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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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The purpose of this research study is to learn whether or not a brief parenting program called Child Adult Relationship Enhancement (CARE) offered at a primary care office can help improve behavior problems in children who are 2-6 years old.
The study will be a randomized controlled trial (RCT) of the CARE intervention. The study will include 2-6 year old children who receive their primary care at the Children's Hospital of Philadelphia, South Philadelphia Primary Care clinic and whose caregiver and/or doctor has concern about a behavior problem in the child. The caregivers will also be subjects in the study.
Child-caregiver pairs who agree to be in the study will be randomly assigned to receive the CARE training immediately or in 3-4 months.
The CARE intervention will last 6 weeks and child behavior and parenting will be measured at baseline, 6-8 weeks, and 14-18 weeks. Investigators will also measure parent satisfaction with the CARE intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed CARE | No Intervention | 40 child-caregiver pairs will be randomized to usual treatment plus delayed CARE (control). Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed CARE) will receive the CARE training, if desired. | |
| Immediate CARE | Experimental | 40 child-caregiver pairs will be randomized to usual treatment plus immediate CARE. The trainings are administered to groups of 4-10 caregivers at a time and are led by two mental health providers trained in the CARE curriculum. The children do not attend the training; however, caregivers are expected to practice the skills that they learn in CARE with their child between sessions. The curriculum involves 6 sessions over 6-8 weeks. Each session will be 1-2 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate CARE | Behavioral | CARE is a group parent training informed by the principles of Parent Child Interaction Therapy and was developed by Trauma Treatment Training Center and CHOP Policy Lab. CARE has been used in many populations including residential treatment center/domestic violence shelter staff, daycare providers, graduate students, biological parents, and foster parents/caseworkers. Goals are to decrease stress for caregivers, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. The training teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. The focus is on giving attention to child's pro-social behavior and ignoring minor misbehavior. The second phase teaches techniques for giving effective commands. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks) | Behavior will be measured by the Eyberg Child Behavior Inventory (ECBI). The primary outcome is the ECBI change score (time 3-time1). The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years. The instrument contains 36 items that assess behavior on two scales. The problem scale provides a yes/no problem identification rating for each item, and the sum of yes responses yields a problem score with a potential range from 0 to 36 with a clinical cutoff of 15. The intensity scale provides a frequency-of-occurrence rating for each item, ranging from never (1) to always (7) and the ratings are summed to yield an intensity score with a potential range from 36 to 252 with a clinical cutoff of 131. Higher scores indicate worse outcomes. The ECBI has demonstrated strong internal consistency, test-retest reliability, and discriminant validity and has been shown to be a sensitive indicator of intervention efficacy for child behavior problems. | Mean Change in ECBI Scores from Baseline to 14-18 weeks. Decreases in ECBI scores reflect improvements in behavior. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks) | Investigators want to determine the effect of the CARE intervention on diminishing harsh parenting as measured by the Adult Adolescent Parenting Inventory-2. The Adult Adolescent Parenting Inventory-2 (AAPI-2) is a 40 item parent-report measure that assesses parenting attitudes along 5 dimensions: inappropriate expectations of children, parental lack of empathy towards children's needs, strong belief in the use of corporal punishment as a means of discipline, reversing parent-child role responsibilities, and oppressing children's power and independence. Parents respond to each item on a five point Likert Scale of Strongly Agree, Agree, Disagree, Strongly Disagree and Uncertain. This measure yields a score of 1-10 for each construct. Higher scores indicate lower risk parenting. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne N Wood, MD, MSHP | CHOP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHOP Primary Care, South Philadelphia | Philadelphia | Pennsylvania | 19145 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Intervention: Delayed CARE | 40 child-caregiver pairs will be randomized to usual treatment plus delayed PriCARE (control). Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed PriCARE) will receive the PriCARE training, if desired. |
| FG001 | Experimental: Immediate CARE | 80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention: Delayed CARE | 40 child-caregiver pairs will be randomized to usual treatment plus delayed PriCARE (control). Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed PriCARE) will receive the PriCARE training, if desired |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | For child participants age in years was collected. For caregiver participants age was categorized as 18-29 years, 30-39 years, or 40-49 years, 50-59 years, 60-69 years, or 70 plus years. There were 3 caregivers in the 60-69 years for which it is unknown whether they were <65 or >65. For reporting purposes these 3 caregivers are included in the < 65 category in the table below. |
| 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 the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks) | Behavior will be measured by the Eyberg Child Behavior Inventory (ECBI). The primary outcome is the ECBI change score (time 3-time1). The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years. The instrument contains 36 items that assess behavior on two scales. The problem scale provides a yes/no problem identification rating for each item, and the sum of yes responses yields a problem score with a potential range from 0 to 36 with a clinical cutoff of 15. The intensity scale provides a frequency-of-occurrence rating for each item, ranging from never (1) to always (7) and the ratings are summed to yield an intensity score with a potential range from 36 to 252 with a clinical cutoff of 131. Higher scores indicate worse outcomes. The ECBI has demonstrated strong internal consistency, test-retest reliability, and discriminant validity and has been shown to be a sensitive indicator of intervention efficacy for child behavior problems. | Eyberg Child Behavior Inventory (ECBI) is a 36 item parent rating scale that measures problem behaviors in children 2-16 on the problem scale and intensity scale.The intensity score (range 36-252) is the total frequency of occurrence for the behaviors. The problem score (range 0-36) is the total number of behaviors for which the response is "yes". | Posted | Mean | 95% Confidence Interval | units on a scale | Mean Change in ECBI Scores from Baseline to 14-18 weeks. Decreases in ECBI scores reflect improvements in behavior. |
2 years
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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 | No Intervention: Delayed CARE | 40 child-caregiver pairs will be randomized to usual treatment plus delayed CARE (control). Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed CARE) will receive the CARE training, if desired. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanne Wood, PI | Children's Hospital of Philadelphia | 267-426-3107 | woodjo@email.chop.edu |
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| Mean change in scores from baseline to 14-18 weeks. Increases in scores indicate decreased risk for abuse and better outcomes. |
| BG001 | Experiemental: Immediate CARE | 80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Caregiver relationship to child | Caregiver relationship is provided for caregiver participants only | Count of Participants | Participants |
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| ECBI Problem Scale | The Eyberg Child Behavior Inventory (ECBI) is a 36 item parent rating scale that measures problem behaviors (externalizing or conduct-disordered behaviors) in children 2-16 on the Intensity scale and the Problem scale. The problem score (range 0-36) is the total number of behaviors for which the parent identifies that the behavior is problematic. Higher scores indicate worse behavioral problems. Baseline ECBI Problem Scale was collected by parental report for Child Participants only. | ECBI measures were only collected on child participants and not caregivers | Mean | Standard Deviation | units on a scale |
|
| ECBI Intensity Scale | The Eyberg Child Behavior Inventory (ECBI) is a 36 item parent rating scale that measures problem behaviors (externalizing or conduct-disordered behaviors) in children 2-16 on the Intensity scale and the Problem scale. Each of the 36 behaviors is rated on a 7-point intensity scale. The Intensity score (range 36-252) is the total frequency of occurrence for the behaviors. Higher scores indicate worse behavioral problems. Baseline ECBI Intensity Scale was collected by parental report for Child Participants only. | ECBI Measures only collected for child participants. | Mean | Standard Deviation | units on a scale |
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| Adult Adolescent Parenting Inventory 2 (AAPI2) | Adult Adolescent Parenting Inventory 2 (AAPI-2) is a 40-item parent self-report measure that assesses parenting attitudes on five subscales: 1) inappropriate expectations of children 2) parental lack of empathy towards child's needs, 3) strong belief in the use of corporal punishment as a means of discipline, 4) reversing parent-child role responsibilities and 5) oppressing child's power and independence. Standardized sten scores for each of the 5 subscales range from 1-10 with lower scores indicating higher risk for child maltreatment. | AAPI scores were only measured and reported for caregiver participants | Mean | Standard Deviation | units on a scale |
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| Secondary | Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks) | Investigators want to determine the effect of the CARE intervention on diminishing harsh parenting as measured by the Adult Adolescent Parenting Inventory-2. The Adult Adolescent Parenting Inventory-2 (AAPI-2) is a 40 item parent-report measure that assesses parenting attitudes along 5 dimensions: inappropriate expectations of children, parental lack of empathy towards children's needs, strong belief in the use of corporal punishment as a means of discipline, reversing parent-child role responsibilities, and oppressing children's power and independence. Parents respond to each item on a five point Likert Scale of Strongly Agree, Agree, Disagree, Strongly Disagree and Uncertain. This measure yields a score of 1-10 for each construct. Higher scores indicate lower risk parenting. | Adult Adolescent Parenting Inventory (AAPI-2): assesses 5 parenting constructs:1) inappropriate expectations of child,2) lack of empathy towards child's needs,3)belief in corporal punishment, 4) reverses parent-child roles, 5) restricts child's power and independence.Range for each scale is 1-10. Lower numbers indicate higher abuse risk. | Posted | Mean | Standard Deviation | units on a scale | Mean change in scores from baseline to 14-18 weeks. Increases in scores indicate decreased risk for abuse and better outcomes. |
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| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Experiemental: Immediate CARE | 80 child-caregiver pairs will be randomized to immediate CARE. Immediate CARE: CARE is a group parent training informed by the principles of Parent Child Interaction Therapy and was developed by Trauma Treatment Training Center and CHOP Policy Lab. CARE has been used in many populations including residential treatment center/domestic violence shelter staff, daycare providers, graduate students, biological parents, and foster parents/caseworkers. Goals are to decrease stress for caregivers, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. The training teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. The focus is on giving attention to child's pro-social behavior and ignoring minor misbehavior. The second phase teaches techniques for giving effective commands. | 0 | 160 | 0 | 160 | 0 | 160 |
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| Unknown or Not Reported |
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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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| Grandmother |
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| Use of Corporal Punishment |
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| Parent-Child Family Roles |
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| Children's Power and Independence |
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