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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD093665 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Vanderbilt University Medical Center | OTHER |
| Boston College | OTHER |
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Universal and broad selective parenting education programs that improve parenting skills, increase parents' understanding of child development, and teach positive child discipline strategies can prevent use of corporal punishment and child physical maltreatment. The proposed research addresses this critical need by investigating brief, relatively low-resource intensive primary prevention parenting programs that can be disseminated widely. By reducing cumulative adverse childhood experiences, which include child physical maltreatment, these interventions are expected to reduce long-term health disparities and risks for major public health problems, such as violence, smoking, obesity, drug abuse, risky sexual behavior, mental health disorders, and heart disease, among others
Study design
Our long-term goal is to enlarge the evidence base for low resource-intensive and widely adaptable interventions that effectively target parenting outcomes to reduce risk of child physical abuse in settings with broad reach. The objective of this study is to test the effectiveness of two such interventions in promoting effective parenting and reducing child physical abuse risk as compared with "usual care" parenting education. The central hypothesis is that each of two brief interventions, Triple P-L2 and Play Nicely, will be more effective in improving parenting effectiveness and reducing child behavioral and emotional problems than the "usual care" condition. Full scale Triple-P is an evidence-based, five-level system of interventions shown to reduce risk for child maltreatment when all 5 levels are implemented. However, implementation of a single level would be much less costly, more easily disseminated, and might in itself reduce risk in a broader population. Play Nicely is a brief computer-based intervention that has shown preliminary evidence for shifting attitudes about use of physical discipline when implemented in a pediatric primary care setting. However, it has yet to be tested within a large randomized-controlled trial (RCT). The rationale for this study is to be able to inform policy for parent service or clinic centers serving high-volumes of parents that are interested in adopting relatively low-resource intensive interventions in order to reduce risk of child physical abuse and improve child health and development trajectories.
This is a community-based RCT. Parents (n=1200) with children 2 to 7 years of age will be recruited from local Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics and by open recruitment. Once consented, they will be enrolled, a baseline interview will be conducted, and they will be randomly assigned to one of 3 conditions: (1) Triple P-Level 2 only (L2) intervention, (2) Play Nicely intervention, or (3) a "usual care" control group. Three months later, a follow-up interview will be conducted in order to test for intervention effects. In addition, a long term follow-up will be conducted to test sustained effects of the intervention. Participants' children (n=1200) will be enrolled for the long term follow-up. Children will be invited to participate in order for the adult participant to be observed interacting with the child in several very benign behavioral activities. Adult participants that do not want to enroll their child may participate in the long term follow-up survey which they will have previously consented to. Our study name for presentation in the local community is "Tulane Innovations in Positive Parenting Study" (TIPPS).
Subject Population
We will recruit a total number of 2400 participants for this study. We will recruit 1200 adult participants from City of New Orleans and Jefferson Parish WIC Clinics. During the long-term follow-up visit, one child for each adult with be enrolled (n=1200).
Procedure
Recruitment: Recruitment has taken place in WIC clinic waiting rooms. If a parent is eligible and interested, the TIPPS Staff Member will then confirm that she has completed all necessary WIC documentation and that she is scheduled for a follow-up appointment with WIC before moving forward with consent and enrollment.
Baseline Interview: After the participant is taken through the informed consent process, a TIPPS Team Member will then conduct the Baseline interview. Once the Baseline Interview is complete (approximately 45 minutes), the participant will be informed of their random assignment to one of three conditions: (1) Triple P-Level 2, (2) Play Nicely, or (3) Control. The next procedure will then depend upon which of the three groups the person is assigned to. (See "Arms and Interventions" section for more details.) Debrief: Once both the Baseline Interview and the Intervention phase are complete, a TIPPS Team Member will schedule the 3-month Follow-Up Appointment, provide the control condition, provide an area-specific resource guide, and give the participant our incentive. The whole procedure (enrollment, baseline interview, intervention, and debrief) is expected to take no more than 2 hours.
3-Month Follow-Up Visit: If the participant has a WIC appointment, when they return to WIC for their 3-month visit and once they've completed their WIC documentation, a TIPPS Team Member will conduct the 3-month interview with them. This interview should take no more than 45 minutes. As with the baseline visit, childcare will be offered when available and the Suicide Risk Protocol will be followed if needed. In the event that the participant cannot return to the study site for their 3-month visit, the TIPPS team member will schedule the 3-Month interview as a phone interview. If the participant is unwilling or unable to complete the follow-up interview over the phone, a follow-up interview will be scheduled at a more convenient location for the participant, such as a local business or the participant's home.
The long term follow-up visit protocol described below is possible due to funding from NICHD which will fund this study from 7/2018 - 6/2023.
Long Term Follow-Up Visit : Participants will be asked to arrive at the research site with their child indicated as the index child in the baseline survey visit. A trained research team member will conduct the informed consent procedures followed at the baseline visit. If the adult participate does not want her child to participate, she may complete the long-term follow-up survey which she has consented to previously. If she agrees to participate and gives permission for her child to participate, she must review and sign a new consent form before participating in any Long Term Follow-Up activities. The informed consent form will be a record of the mother's agreement for both her and her child to participate. Upon completion of the informed consent process, a research assistant will conduct the Long Term Follow-Up interview with the adult participant. A separate research assistant will engage the child participant in several tasks. The first task will be the NIH Toolbox, which measures Cognitive flexibility and executive function, administered by tablet. Next, the child will be given the Marshmallow Test, which is an inhibitory control task where the child is told to wait for to eat a marshmallow until the research assistant returns to the room, and if they are able to wait, they will get two marshmallows. The time before the child eats the marshmallow is a validated measure of inhibitory control; inhibitory control has been found to be a significant predictor of child health and development outcomes across the life course.
Following the surveys, ECG data will be collected on the child and mother concurrently, acquired using Mindware Technologies mobile recorders, and transmitted via wireless signals to a computer monitored by a research assistant. After participant and child leads have been connected to ECG machines, the participant and child will do 3 very benign behavioral activities together: 1) watch a short video, 2) tell a story together, and 3) engage in a cooperative task (drawing with an Etch A Sketch). Interactions will be video recorded with parental consent and child assent and coding of parent and child behaviors will be done using the coding interactive behavior (CIB) coding system. Respiratory Sinus Arrhythmia (RSA) values will be processed in 30-second epochs across tasks for mothers and for children, and multilevel growth models will be built examining each 30-second epoch over the course of the task, relative to the individuals' baseline RSA. Dr. Drury will have full oversight of the dyadic coding of video recorded interactions between mother and child. Lastly, a TIPPS Team Member will provide the participant with locally-based health care resources guide.
4. Benefits
There will be no direct benefits to subjects for participating in this research, but the knowledge gained from the study may benefit society in general. Anticipated benefits might include a participant's greater understanding of positive parenting techniques.
5. Costs
There will be no costs to the subject for participating in this research study.
6. Alternatives
Subjects always have the option to not participate in the research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program 1 | Experimental | Triple P-Level 2 (TPL2), parenting education and consultation |
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| Program 2 | Experimental | Play Nicely (PN), multimedia, computer-based parenting education |
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| Control | Placebo Comparator | Our "usual care" control group participants receive a resource and referral list for local social services |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triple P-Level 2 | Other | Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice. |
| Measure | Description | Time Frame |
|---|---|---|
| Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up | The measure was collected at baseline, 3 month post-intervention, and 4 year post-intervention. This question asks participants "How often on average in the past month have you spanked your child?" with seven categories: 0) never, 1) once or twice in the past month, 2) about once a week, 3) about twice a week, 4) about once every other day, 5) about once a day, and 6) more than once a day. Using the 0-6 score response range, the outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates decrease in frequency of spanking at the post-intervention timepoint. | Baseline, 3 months post-intervention, 4 years post-intervention |
| Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up | The Attitudes Towards Spanking (ATS) scale was collected at baseline, 3 months post-intervention, and 4 years post-intervention. The scale score response range was 0-28, with a higher number being stronger support for spanking. This change outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates a decrease in approval of spanking at the post-intervention time point. | Baseline, 3 months post-intervention, 4 years post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Parent - Child Discipline Practices | The Parental Discipline scale of the Parenting and Family Adjustment Scale (PAFAS) was collected at baseline, 3 month follow up, and long-term follow-up. This scale ranges from 0-54, with a higher number indicating more positive parenting. | Baseline, 3 months post-intervention, 4 years post-intervention |
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Inclusion Criteria:
Adult participants must be:
Child participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine A Taylor, PhD | Boston College School of Social Work | Principal Investigator |
| Julia M Fleckman, PhD | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University School of Public Health and Tropical Medicine | New Orleans | Louisiana | 70112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Program 1 (Triple P-Level 2) | Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice. |
| FG001 | Program 2 (Play Nicely) | Play Nicely (PN), multimedia, computer-based parenting education Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes. |
| FG002 | Control | Our "usual care" control group participants receive a resource and referral list for local social services |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Longitudinal Assessment-Adults Only |
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| 4 Year Post-Intervention Clinic-Children |
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| ID | Title | Description |
|---|---|---|
| BG000 | Program 1 (Triple P-Level 2) | Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2: Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The numbers entered for "adults" reflect the number of participants who completed the baseline portion of the overall study. The numbers of "index children" entered reflect those who participated in the 4 year post-intervention clinic visit (also known as the "dyadic visit"). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up | The measure was collected at baseline, 3 month post-intervention, and 4 year post-intervention. This question asks participants "How often on average in the past month have you spanked your child?" with seven categories: 0) never, 1) once or twice in the past month, 2) about once a week, 3) about twice a week, 4) about once every other day, 5) about once a day, and 6) more than once a day. Using the 0-6 score response range, the outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates decrease in frequency of spanking at the post-intervention timepoint. | All available survey data for each time point was used. The baseline to 4 year post-intervention "number analyzed" differs from the baseline to 3 month post-intervention due to study attrition (lost to follow-up). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months post-intervention, 4 years post-intervention |
|
Adverse event data was collected throughout the study period (from baseline through 4-year post-intervention).
Adverse events and all-cause mortality are reported for all adult (n=880) and child participants (n=253).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Program 1 (Triple P-Level 2) - Adults | Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2: Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Taylor, PhD, LCSW, MPH | Boston College School of Social Work | (617) 552-4033 | catherine.taylor.2@bc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2022 | Jun 13, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2024 | Jun 13, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Play Nicely | Other | Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes. |
|
| Usual care | Other | Our "usual care" control group participants receive a resource and referral list for local social services |
|
| Child - Behavioral and Emotional Adjustment |
The Child Adjustment and Parent Efficacy Scale (CAPES) scale was collected at baseline, 3 month follow-up, and long-term follow-up. This scale ranges from 0-81, with a higher number indicating increased levels of emotional or behavioral problems. |
| Baseline, 3 months post-intervention, 4 years post-intervention |
| Child - Externalizing, Internalizing, and Total Symptoms | The 113 item Child Behavior Checklist (CBCL) scale was collected at 4 year long-term follow-up. The outcome is a T-score calculated for total symptoms, with a higher score indicating more internalizing and externalizing behaviors. For the T-score of the CBCL, the population mean is 50 and the standard deviation is 10. T-Scores less than 60 are considered to be in the normal range, the borderline range consists of T-scores of 60-63, and the clinical range consists of T-scores greater than 63. | 4 years post-intervention |
| Parent Sensitivity | The outcome measure reported is the parent sensitivity score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-115. A higher score indicates a higher level of parent sensitivity from caregiver to child. | 4 years post-intervention |
| Child Social Involvement | The outcome measure reported is the child social involvement score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-70. A higher score indicates a higher level of child social involvement from caregiver to child. | 4 years post-intervention |
| Child Negative Emotionality | The outcome measure reported is the child negative emotionality score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-30. A higher score indicates a higher level of child negative emotionality from child. | 4 years post-intervention |
| Dyadic Negative States | The outcome measure reported is the dyadic negative states score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-10. A higher score indicates a higher level of dyadic negative states between caregiver and child. | 4 years post-intervention |
| Dyadic Reciprocity | The outcome measure reported is the dyadic reciprocity score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-15. A higher score indicates a higher level of dyadic reciprocity between caregiver and child. | 4 years post-intervention |
| Parent Limit Setting | The outcome measure reported is the parent limit setting score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-35. A higher score indicates a higher level of parent limit setting from caregiver. | 4 years post-intervention |
| Child Compliance | The outcome measure reported is the child compliance score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-20. A higher score indicates a higher level child compliance. | 4 years post-intervention |
| Parent Baseline RSA | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the baseline task for the caregiver. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating greater variability between interbeat intervals during the task. | 4 years post-intervention |
| Child Baseline RSA | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the baseline task for the child. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating greater variability between interbeat intervals during the task. | 4 years post-intervention |
| RSA Synchrony Challenge Task | Respiratory sinus arrhythmia (RSA) | 4 years post-intervention |
| RSA Lead/Lag During Challenge Task | Respiratory sinus arrhythmia (RSA) | 4 years post-intervention |
| Parent RSA During Challenge Task | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the challenge task for the caregiver. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task. | 4 years post-intervention |
| Child RSA During Challenge Task | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the challenge task for the child. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task. | 4 years post-intervention |
| RSA Synchrony During Social Interaction Task | Respiratory sinus arrhythmia (RSA) | 4 years post-intervention |
| RSA Lead/Lag During Social Interaction Task | Respiratory sinus arrhythmia (RSA) | 4 years post-intervention |
| Parent RSA During Social Interaction Task | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the social interaction task for the caregiver. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task. | 4 years post-intervention |
| Child RSA During Social Interaction Task | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the social interaction task for the child. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task. | 4 years post-intervention |
| Child - Cognitive Flexibility | The outcome measure is the age-corrected scale score of cognitive flexibility (Dimensional Change Card Sort) computed by the NIH Toolbox software. The score is standardized such that the mean score in the overall population is 100 and the standard deviation is 15, with scores above 100 being above the average performance for children of the indicated age. | 4 years post-intervention |
| Child - Delay Time | Behavioral inhibitory control/ marshmallow task | 4 years post-intervention |
| Child - Executive Function | The outcome measure is the age-corrected scale score of executive function (Flanker Inhibitory Control and Attention Test) computed by the NIH Toolbox software. The score is standardized such that the mean score in the overall population is 100 and the standard deviation is 15, with scores above 100 being above the average performance for children of the indicated age. | 4 years post-intervention |
| Child - Distraction Strategy | Behavioral inhibitory control/ marshmallow task | 4 years post-intervention |
| Child - Distress Level | Behavioral inhibitory control/ marshmallow task | 4 years post-intervention |
| Withdrawal by Subject |
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| Baseline survey incomplete |
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| Death |
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| NOT COMPLETED |
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| BG001 | Program 2 (Play Nicely) | Play Nicely (PN), multimedia, computer-based parenting education Play Nicely: Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes. |
| BG002 | Control | Our "usual care" control group participants receive a resource and referral list for local social services Usual care: Our "usual care" control group participants receive a resource and referral list for local social services |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | The numbers entered for "adults" reflect the number of participants who completed the baseline portion of the overall study. The numbers of "index children" entered reflect those who participated in the 4 year post-intervention clinic visit (also known as the "dyadic visit"). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The numbers entered for "adults" reflect the number of participants who completed the baseline portion of the overall study. The numbers of "index children" entered reflect those who participated in the 4 year post-intervention clinic visit (also known as the "dyadic visit"). | Count of Participants | Participants |
|
| Race (NIH/OMB) | The numbers entered for "adults" reflect the number of participants who completed the baseline portion of the overall study. The numbers of "index children" entered reflect those who participated in the 4 year post-intervention clinic visit (also known as the "dyadic visit"). | Count of Participants | Participants |
|
| Region of Enrollment | The numbers entered reflect the overall study. All participants, including the index children who comprise part of the sample at the 4 year post-intervention clinic visit, all resided in the same region, the United States. | Number | participants |
|
| OG000 | Program 1 (Triple P-Level 2) | Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2: Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice. |
| OG001 | Program 2 (Play Nicely) | Play Nicely (PN), multimedia, computer-based parenting education Play Nicely: Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes. |
| OG002 | Control | Our "usual care" control group participants receive a resource and referral list for local social services Usual care: Our "usual care" control group participants receive a resource and referral list for local social services |
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| Primary | Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up | The Attitudes Towards Spanking (ATS) scale was collected at baseline, 3 months post-intervention, and 4 years post-intervention. The scale score response range was 0-28, with a higher number being stronger support for spanking. This change outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates a decrease in approval of spanking at the post-intervention time point. | All available survey data for each time point was used. The baseline to 4 year post-intervention "number analyzed" differs from the baseline to 3 month post-intervention due to study attrition (lost to follow-up). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months post-intervention, 4 years post-intervention |
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| Secondary | Parent - Child Discipline Practices | The Parental Discipline scale of the Parenting and Family Adjustment Scale (PAFAS) was collected at baseline, 3 month follow up, and long-term follow-up. This scale ranges from 0-54, with a higher number indicating more positive parenting. | All available survey data for each time point was used. The baseline, 3 month post-intervention, and 4 year post-intervention "number analyzed" differs due to study attrition (lost to follow-up). | Posted | Mean | Standard Error | score on a scale | Baseline, 3 months post-intervention, 4 years post-intervention |
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| Secondary | Child - Behavioral and Emotional Adjustment | The Child Adjustment and Parent Efficacy Scale (CAPES) scale was collected at baseline, 3 month follow-up, and long-term follow-up. This scale ranges from 0-81, with a higher number indicating increased levels of emotional or behavioral problems. | All available survey data for each time point was used. The baseline, 3 month post-intervention, and 4 year post-intervention "number analyzed" differs due to study attrition (lost to follow-up). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months post-intervention, 4 years post-intervention |
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| Secondary | Child - Externalizing, Internalizing, and Total Symptoms | The 113 item Child Behavior Checklist (CBCL) scale was collected at 4 year long-term follow-up. The outcome is a T-score calculated for total symptoms, with a higher score indicating more internalizing and externalizing behaviors. For the T-score of the CBCL, the population mean is 50 and the standard deviation is 10. T-Scores less than 60 are considered to be in the normal range, the borderline range consists of T-scores of 60-63, and the clinical range consists of T-scores greater than 63. | Posted | Mean | Standard Deviation | T-score | 4 years post-intervention |
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| Secondary | Parent Sensitivity | The outcome measure reported is the parent sensitivity score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-115. A higher score indicates a higher level of parent sensitivity from caregiver to child. | These numbers reflect the 236 adult participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for adult participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6). | Posted | Mean | Standard Deviation | score on a scale | 4 years post-intervention |
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| Secondary | Child Social Involvement | The outcome measure reported is the child social involvement score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-70. A higher score indicates a higher level of child social involvement from caregiver to child. | These numbers reflect the child participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for child participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6). | Posted | Mean | Standard Deviation | score on a scale | 4 years post-intervention |
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| Secondary | Child Negative Emotionality | The outcome measure reported is the child negative emotionality score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-30. A higher score indicates a higher level of child negative emotionality from child. | These numbers reflect the child participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for child participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6). | Posted | Mean | Standard Deviation | score on a scale | 4 years post-intervention |
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| Secondary | Dyadic Negative States | The outcome measure reported is the dyadic negative states score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-10. A higher score indicates a higher level of dyadic negative states between caregiver and child. | These numbers are adult-child dyads (n=236 total dyads, adults [n=236], and index children [n=236]) that completed the 4-year post-intervention clinic visit. No data is available for 17 dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6). | Posted | Mean | Standard Deviation | score on a scale | 4 years post-intervention |
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| Secondary | Dyadic Reciprocity | The outcome measure reported is the dyadic reciprocity score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-15. A higher score indicates a higher level of dyadic reciprocity between caregiver and child. | These numbers are adult-child dyads (n=236 total dyads, adults [n=236], and index children [n=236]) that completed the 4-year post-intervention clinic visit. No data is available for 17 dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6). | Posted | Mean | Standard Deviation | score on a scale | 4 years post-intervention |
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| Secondary | Parent Limit Setting | The outcome measure reported is the parent limit setting score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-35. A higher score indicates a higher level of parent limit setting from caregiver. | These numbers reflect the 236 adult participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for adult participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6). | Posted | Mean | Standard Deviation | score on a scale | 4 years post-intervention |
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| Secondary | Child Compliance | The outcome measure reported is the child compliance score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-20. A higher score indicates a higher level child compliance. | These numbers reflect the child participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for child participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6). | Posted | Mean | Standard Deviation | score on a scale | 4 years post-intervention |
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| Secondary | Parent Baseline RSA | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the baseline task for the caregiver. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating greater variability between interbeat intervals during the task. | Posted | Mean | Standard Deviation | ms^2 | 4 years post-intervention |
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| Secondary | Child Baseline RSA | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the baseline task for the child. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating greater variability between interbeat intervals during the task. | Posted | Mean | Standard Deviation | ms^2 | 4 years post-intervention |
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| Secondary | RSA Synchrony Challenge Task | Respiratory sinus arrhythmia (RSA) | Not Posted | Jun 2025 | 4 years post-intervention | Participants |
| Secondary | RSA Lead/Lag During Challenge Task | Respiratory sinus arrhythmia (RSA) | Not Posted | Jun 2025 | 4 years post-intervention | Participants |
| Secondary | Parent RSA During Challenge Task | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the challenge task for the caregiver. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task. | Posted | Mean | Standard Deviation | ms^2 | 4 years post-intervention |
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| Secondary | Child RSA During Challenge Task | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the challenge task for the child. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task. | Posted | Mean | Standard Deviation | ms^2 | 4 years post-intervention |
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| Secondary | RSA Synchrony During Social Interaction Task | Respiratory sinus arrhythmia (RSA) | Not Posted | Jun 2025 | 4 years post-intervention | Participants |
| Secondary | RSA Lead/Lag During Social Interaction Task | Respiratory sinus arrhythmia (RSA) | Not Posted | Jun 2025 | 4 years post-intervention | Participants |
| Secondary | Parent RSA During Social Interaction Task | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the social interaction task for the caregiver. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task. | Posted | Mean | Standard Deviation | ms^2 | 4 years post-intervention |
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| Secondary | Child RSA During Social Interaction Task | The outcome measure is the average respiratory sinus arrhythmia (RSA) during the social interaction task for the child. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task. | Posted | Mean | Standard Deviation | ms^2 | 4 years post-intervention |
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| Secondary | Child - Cognitive Flexibility | The outcome measure is the age-corrected scale score of cognitive flexibility (Dimensional Change Card Sort) computed by the NIH Toolbox software. The score is standardized such that the mean score in the overall population is 100 and the standard deviation is 15, with scores above 100 being above the average performance for children of the indicated age. | Posted | Mean | Standard Deviation | T-score | 4 years post-intervention |
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| Secondary | Child - Delay Time | Behavioral inhibitory control/ marshmallow task | This test is only valid for children that have not yet begun first grade. Due to a later than expected commencement of our data collection at the 4 year post-intervention clinic visit, none of the children in our study met this requirement and hence the test was not administered. | Posted | 4 years post-intervention |
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| Secondary | Child - Executive Function | The outcome measure is the age-corrected scale score of executive function (Flanker Inhibitory Control and Attention Test) computed by the NIH Toolbox software. The score is standardized such that the mean score in the overall population is 100 and the standard deviation is 15, with scores above 100 being above the average performance for children of the indicated age. | Posted | Mean | Standard Deviation | T-score | 4 years post-intervention |
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| Secondary | Child - Distraction Strategy | Behavioral inhibitory control/ marshmallow task | This test is only valid for children that have not yet begun first grade. Due to a later than expected commencement of our data collection at the 4 year post-intervention clinic visit, none of the children in our study met this requirement and hence the test was not administered. | Posted | 4 years post-intervention |
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| Secondary | Child - Distress Level | Behavioral inhibitory control/ marshmallow task | This test is only valid for children that have not yet begun first grade. Due to a later than expected commencement of our data collection at the 4 year post-intervention clinic visit, none of the children in our study met this requirement and hence the test was not administered. | Posted | 4 years post-intervention |
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| 4 |
| 289 |
| 0 |
| 289 |
| 0 |
| 289 |
| EG001 | Program 2 (Play Nicely) - Adults | Play Nicely (PN), multimedia, computer-based parenting education Play Nicely: Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes. | 4 | 294 | 0 | 294 | 0 | 294 |
| EG002 | Control - Adults | Our "usual care" control group participants receive a resource and referral list for local social services Usual care: Our "usual care" control group participants receive a resource and referral list for local social services | 3 | 297 | 0 | 297 | 0 | 297 |
| EG003 | Program 1 (Triple P-Level 2) - Children | The index children of the parents who were assigned to Triple P-Level 2 (TPL2): Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2: Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice. | 0 | 81 | 0 | 81 | 0 | 81 |
| EG004 | Program 2 (Play Nicely) - Children | The index children of the parents who were assigned to Play Nicely (PN): Play Nicely: Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes. | 1 | 72 | 0 | 72 | 0 | 72 |
| EG005 | Control - Children | The index children of the parents who were assigned to control: Our "usual care" control group participants receive a resource and referral list for local social services Usual care: Our "usual care" control group participants receive a resource and referral list for local social services | 0 | 100 | 0 | 100 | 0 | 100 |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Title | Measurements |
|---|---|
| <=18 years |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Title | Measurements |
|---|---|
| Female |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
| Hispanic or Latino |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Baseline to 4 years post-intervention |
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| 3 month post-intervention |
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| 4 years post-intervention |
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| 3 month post-intervention |
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| 4 years post-intervention |
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