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| Name | Class |
|---|---|
| Loma Linda University | OTHER |
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The Pro-Parenting Study seeks to determine the added benefit of targeting both parenting stress and parent management strategies to more effectively reduce behavior problems among children with developmental delay (DD). Findings from this study will improve the scientific understanding of evidence-based interventions for behavior problems among children with DD and the mechanisms underlying therapeutic change.
Behavior problems are a common and concerning challenge among children with developmental delay (DD). Approximately 50% of children with DD have a comorbid mental disorder or serious behavior problems- a prevalence three times as high as that found in typically developing youths. Behavioral parent training (BPT) is the gold-standard intervention for treating child behavior problems in typically developing children and in children with DD. However, high levels of parental stress are associated with reduced or no response to BPT for children with DD. Consequently, parental stress may attenuate the efficacy of the gold-standard, empirically supported treatment for behavior problems among children with DD. As such, parental stress is a critical point of intervention for improving both parent and child outcomes in families of children with DD. The purpose of this study is to quantify the therapeutic benefit of adding a parent stress-reduction intervention prior to delivering BPT in order to more effectively reduce child behavior problems, and to investigate the mechanisms through which intervention outcomes occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPT-E | Experimental | Behavioral parent training (BPT) plus a psychoeducation program. Includes a 10-week standard BPT, plus a 6-week psychoeducation program delivered prior to the standard BPT. |
|
| BPT-M | Experimental | Behavioral parent training (BPT) plus mindfulness-based stress reduction (MBSR). Includes a 10-week standard BPT, plus a 6-week MBSR delivered prior to the standard BPT. |
|
| Teachers | No Intervention | At each wave of data collection, caregivers in both conditions were asked to identify a teacher who could provide an evaluation of their child's behavior outside the home. Participating teachers completed a brief 2-page questionnaire about the child. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPT-M | Behavioral | Participants randomized to the BPT-M condition receive the Mindfulness-Based Stress Reduction (MBSR) intervention, followed by Behavioral Parent Training (BPT). The MBSR module includes six weekly 2.5 hour group sessions, 30-45 minutes of daily home practice guided by audio CDs, and an MBSR parent workbook. In the sessions, participants practice formal mindfulness exercises, and are provided instruction on stress physiology and using mindfulness for coping with stress in everyday life. The BPT component of the intervention includes 10 weekly sessions lasting 2.5 hours. Each session is structured around videotape vignettes and uses discussion, role-playing, modeling, and feedback to foster mastery of the material. Parents are given weekly homework assignments and practice their skills. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Child Behavior Problems (Parent Report) | Parents report on child behavior using the Child Behavior Checklist-Ages 1.5-5 years (Achenbach, 2000), a 99-item questionnaire that assesses behavioral problems in young children. Parents were asked to rate how accurately each item described their child's behavior over the past 2 months using a 3-pt scale (0=not true/ 1= somewhat or sometimes true/ 2= very true or often true). A Total Behavior Problems score was derived by taking the sum of all 99 items, with a possible range of 0-198. A high score indicates greater problem behavior. | baseline, immediately after 16-week intervention, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Parenting Behavior (Parent Report) | Parents report on their parenting behavior using the Parenting Practices Interview (The Incredible Years, 2015), a 73-item questionnaire with 7 summary scales. Parents were asked how often they engaged in various parenting practices when their child misbehaved, or their likelihood of responding with a certain parenting behavior in provided scenarios of negative child behavior. The Appropriate Discipline summary scale (12 items) was used in the present study. Scores ranged from 1 to 7. Higher scores indicate greater use of appropriate disciplinary practices. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura L McIntyre, PhD | University of Oregon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States | ||
| University of Oregon |
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A total of 1041 families were assessed for eligibility, and 779 were excluded (591 did not meet inclusion criteria, 43 refused to participate, and 145 were excluded for other reasons such as not completing screening, geographic reasons, or scheduling challenges). In the end, 262 families (i.e., caregiver + child) were randomized and assigned to an arm. Children's current teachers were also invited to participate at each wave. A total of 660 teachers were invited; 438 completed a survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | BPT-E | Behavioral parent training (BPT) plus a psychoeducation program. Includes a 10-week standard BPT, plus a 6-week psychoeducation program delivered prior to the standard BPT. BPT-E: Participants randomized to the BPT-E condition will received 6 weeks of a psychoeducation program followed by 10 weeks of the Behavioral Parent Training (BPT) used in both conditions. The psychoeducation module consists of 6 weekly 2.5-hour sessions, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Each of the 6 weekly sessions includes a general topic for discussion. These include preparing for IEP meetings, navigating the regional center and developmental service agencies, communicating with teachers, advocacy, sibling issues, and community resources. |
| FG001 | BPT-M | Behavioral parent training (BPT) plus mindfulness-based stress reduction (MBSR). Includes a 10-week standard BPT, plus a 6-week MBSR delivered prior to the standard BPT. BPT-M: Participants randomized to the BPT-M condition receive the Mindfulness-Based Stress Reduction (MBSR) intervention, followed by Behavioral Parent Training (BPT). The MBSR module includes six weekly 2.5 hour group sessions, 30-45 minutes of daily home practice guided by audio CDs, and an MBSR parent workbook. In the sessions, participants practice formal mindfulness exercises, and are provided instruction on stress physiology and using mindfulness for coping with stress in everyday life. The BPT component of the intervention includes 10 weekly sessions lasting 2.5 hours. Each session is structured around videotape vignettes and uses discussion, role-playing, modeling, and feedback to foster mastery of the material. Parents are given weekly homework assignments and practice their skills. |
| FG002 | Teachers | Caregivers in both conditions were asked to identify a teacher at each wave of data collection who could provide an evaluation of the child's behavior outside the home. Teacher participation was not longitudinal, meaning that different teachers provided evaluations at each wave of data collection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
At baseline,131 caregivers in each condition provided data for themselves and their children, and 128 children in each condition participated in observation/ play tasks. Three additional children engaged in play tasks at later waves and are included here as having "started" the study. The current teacher of each child was recruited at each wave, resulting in a total of 438 teachers providing data about students at some point during the study. 170 teachers completed surveys at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | BPT-E | Behavioral parent training (BPT) plus a psychoeducation program. Includes a 10-week standard BPT, plus a 6-week psychoeducation program delivered prior to the standard BPT. BPT-E: Participants randomized to the BPT-E condition will received 6 weeks of a psychoeducation program followed by 10 weeks of the Behavioral Parent Training (BPT) used in both conditions. The psychoeducation module consists of 6 weekly 2.5-hour sessions, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Each of the 6 weekly sessions includes a general topic for discussion. These include preparing for IEP meetings, navigating the regional center and developmental service agencies, communicating with teachers, advocacy, sibling issues, and community resources. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One caregiver in the BPT-M condition did not answer question. Child age was measured in years in the first cohort but months in later cohorts. Given that age was measured differently for the first cohort, their data are not included here to simplify reporting. Teacher age was measured with ranges rather than exact years. These data are included in a separate table. |
| 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 | Change From Baseline in Child Behavior Problems (Parent Report) | Parents report on child behavior using the Child Behavior Checklist-Ages 1.5-5 years (Achenbach, 2000), a 99-item questionnaire that assesses behavioral problems in young children. Parents were asked to rate how accurately each item described their child's behavior over the past 2 months using a 3-pt scale (0=not true/ 1= somewhat or sometimes true/ 2= very true or often true). A Total Behavior Problems score was derived by taking the sum of all 99 items, with a possible range of 0-198. A high score indicates greater problem behavior. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow up surveys). | Posted | Mean | Standard Deviation | score on a scale | baseline, immediately after 16-week intervention, 6 months, 12 months |
|
Caregivers and children were monitored for adverse events over the study period (e.g., up to 24 months from baseline).
Adverse event data were not collected from teachers.
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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 | BPT-E | Behavioral parent training (BPT) plus a psychoeducation program. Includes a 10-week standard BPT, plus a 6-week psychoeducation program delivered prior to the standard BPT. BPT-E: Participants randomized to the BPT-E condition will received 6 weeks of a psychoeducation program followed by 10 weeks of the Behavioral Parent Training (BPT) used in both conditions. The psychoeducation module consists of 6 weekly 2.5-hour sessions, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Each of the 6 weekly sessions includes a general topic for discussion. These include preparing for IEP meetings, navigating the regional center and developmental service agencies, communicating with teachers, advocacy, sibling issues, and community resources. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Lee McIntyre | University of Oregon | 541-346-7452 | llmcinty@uoregon.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2024 | Nov 7, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2019 | Nov 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| BPT-E | Behavioral | Participants randomized to the BPT-E condition will received 6 weeks of a psychoeducation program followed by 10 weeks of the Behavioral Parent Training (BPT) used in both conditions. The psychoeducation module consists of 6 weekly 2.5-hour sessions, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Each of the 6 weekly sessions includes a general topic for discussion. These include preparing for IEP meetings, navigating the regional center and developmental service agencies, communicating with teachers, advocacy, sibling issues, and community resources. |
|
| baseline, immediately after 16-week intervention, 6 months, 12 months |
| Change From Baseline in Parenting Stress (Parent Self-Report) | Parents report on their parenting stress using the Parenting Stress Index-Fourth Edition, Short Form (PSI4-SF; Abidin, 1995). Parents were asked to indicate their agreement with 36 statements about their feelings on a 5 pt scale (strongly agree, agree, not sure, disagree, strongly disagree). A Total Stress Score was derived from responses to these items, and scores could range from 36-180. High scores indicate greater parenting stress. | baseline, immediately after 16-week intervention, 6 months, 12 months |
| Portland |
| Oregon |
| 97209 |
| United States |
| BG001 | BPT-M | Behavioral parent training (BPT) plus mindfulness-based stress reduction (MBSR). Includes a 10-week standard BPT, plus a 6-week MBSR delivered prior to the standard BPT. BPT-M: Participants randomized to the BPT-M condition receive the Mindfulness-Based Stress Reduction (MBSR) intervention, followed by Behavioral Parent Training (BPT). The MBSR module includes six weekly 2.5 hour group sessions, 30-45 minutes of daily home practice guided by audio CDs, and an MBSR parent workbook. In the sessions, participants practice formal mindfulness exercises, and are provided instruction on stress physiology and using mindfulness for coping with stress in everyday life. The BPT component of the intervention includes 10 weekly sessions lasting 2.5 hours. Each session is structured around videotape vignettes and uses discussion, role-playing, modeling, and feedback to foster mastery of the material. Parents are given weekly homework assignments and practice their skills. |
| BG002 | Teachers | Regardless of treatment condition to which parents were assigned, children's current teachers were invited to participate at each wave of data collection. Participating teachers completed a 2-page questionnaire about their participating student. Because children moved to different classrooms with different teachers throughout the study, different teachers reported on a given child at each wave. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers. | Count of Participants | Participants |
|
| Sex: Female, Male | Demographic data were only collected from 274 teachers. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Demographic data were only collected from 274 teachers. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Demographic data were only collected from 274 teachers. | Count of Participants | Participants |
|
| Region of Enrollment | At baseline, 131 caregivers in the BPT-E and 131 caregivers in the BPT-M conditions provided baseline data about themselves and their child. However, only 128 children in each condition participated in play/ observation tasks at baseline (i.e., N=259 in each condition). At later waves, 3 children (2 in BPT-E and 1 in BPT-M) who did not participate in play tasks at baseline chose to do so, resulting in N=261 in BPT-E (131 parents + 130 children) and N=260 in BPT-M (131 parents + 129 children). | Number | participants |
|
Behavioral parent training (BPT) plus a psychoeducation program.
Includes a 10-week standard BPT, plus a 6-week psychoeducation program delivered prior to the standard BPT.
BPT-E: Participants randomized to the BPT-E condition will received 6 weeks of a psychoeducation program followed by 10 weeks of the Behavioral Parent Training (BPT) used in both conditions. The psychoeducation module consists of 6 weekly 2.5-hour sessions, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Each of the 6 weekly sessions includes a general topic for discussion. These include preparing for IEP meetings, navigating the regional center and developmental service agencies, communicating with teachers, advocacy, sibling issues, and community resources.
| OG001 | BPT-M | Behavioral parent training (BPT) plus mindfulness-based stress reduction (MBSR). Includes a 10-week standard BPT, plus a 6-week MBSR delivered prior to the standard BPT. BPT-M: Participants randomized to the BPT-M condition receive the Mindfulness-Based Stress Reduction (MBSR) intervention, followed by Behavioral Parent Training (BPT). The MBSR module includes six weekly 2.5 hour group sessions, 30-45 minutes of daily home practice guided by audio CDs, and an MBSR parent workbook. In the sessions, participants practice formal mindfulness exercises, and are provided instruction on stress physiology and using mindfulness for coping with stress in everyday life. The BPT component of the intervention includes 10 weekly sessions lasting 2.5 hours. Each session is structured around videotape vignettes and uses discussion, role-playing, modeling, and feedback to foster mastery of the material. Parents are given weekly homework assignments and practice their skills. |
|
|
|
| Secondary | Change From Baseline in Parenting Behavior (Parent Report) | Parents report on their parenting behavior using the Parenting Practices Interview (The Incredible Years, 2015), a 73-item questionnaire with 7 summary scales. Parents were asked how often they engaged in various parenting practices when their child misbehaved, or their likelihood of responding with a certain parenting behavior in provided scenarios of negative child behavior. The Appropriate Discipline summary scale (12 items) was used in the present study. Scores ranged from 1 to 7. Higher scores indicate greater use of appropriate disciplinary practices. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys). | Posted | Mean | Standard Deviation | score on a scale | baseline, immediately after 16-week intervention, 6 months, 12 months |
|
|
|
|
| Secondary | Change From Baseline in Parenting Stress (Parent Self-Report) | Parents report on their parenting stress using the Parenting Stress Index-Fourth Edition, Short Form (PSI4-SF; Abidin, 1995). Parents were asked to indicate their agreement with 36 statements about their feelings on a 5 pt scale (strongly agree, agree, not sure, disagree, strongly disagree). A Total Stress Score was derived from responses to these items, and scores could range from 36-180. High scores indicate greater parenting stress. | Number of participants differs between baseline and follow-up due to attrition (e.g., participants not returning follow-up surveys). | Posted | Mean | Standard Deviation | score on a scale | baseline, immediately after 16-week intervention, 6 months, 12 months |
|
|
|
|
| 0 |
| 261 |
| 0 |
| 261 |
| 0 |
| 261 |
| EG001 | BPT-M | Behavioral parent training (BPT) plus mindfulness-based stress reduction (MBSR). Includes a 10-week standard BPT, plus a 6-week MBSR delivered prior to the standard BPT. BPT-M: Participants randomized to the BPT-M condition receive the Mindfulness-Based Stress Reduction (MBSR) intervention, followed by Behavioral Parent Training (BPT). The MBSR module includes six weekly 2.5 hour group sessions, 30-45 minutes of daily home practice guided by audio CDs, and an MBSR parent workbook. In the sessions, participants practice formal mindfulness exercises, and are provided instruction on stress physiology and using mindfulness for coping with stress in everyday life. The BPT component of the intervention includes 10 weekly sessions lasting 2.5 hours. Each session is structured around videotape vignettes and uses discussion, role-playing, modeling, and feedback to foster mastery of the material. Parents are given weekly homework assignments and practice their skills. | 0 | 260 | 0 | 260 | 0 | 260 |
| EG002 | Teachers | Caregivers in both conditions were asked to identify a teacher at each wave of data collection who could provide an evaluation of the child's behavior at school. Teacher participation was not longitudinal, meaning that different teachers provided evaluations at each wave of data collection. Adverse events data were not collected from teachers. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| Hispanic or Latino |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| Hispanic or Latino |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Immediately after 16-week intervention |
|
|
| 6-month follow-up |
|
|
| 12-month follow-up |
|
|
Baseline versus 6-months after BPT-E intervention |
| Superiority |
| t-test, 2 sided | .000 | Baseline versus 12 months after BPT-E intervention | Superiority |
| t-test, 2 sided | .000 | Baseline versus immediately after 16-week BPT-M intervention | Superiority |
| t-test, 2 sided | .000 | Baseline versus 6 months after BPT-M intervention | Superiority |
| t-test, 2 sided | .000 | Baseline versus 12 months after BPT-M intervention | Superiority |
| Immediately After 16-week Intervention |
|
|
| 6-month Follow-up |
|
|
| 12-month Follow-up |
|
|
Baseline versus 6 months after BPT-E intervention |
| Superiority |
| t-test, 2 sided | .000 | Baseline versus 12 months after BPT-E intervention | Superiority |
| t-test, 2 sided | .000 | Baseline versus immediately after 16-week BPT-M intervention | Superiority |
| t-test, 2 sided | .000 | Baseline versus 6 months after BPT-M intervention | Superiority |
| t-test, 2 sided | .000 | baseline versus 12 months after BPT-M intervention | Superiority |