Pilot of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care

Parent-Child Relations Clinical Trial

— PriCARE  

Official title:

Pilot Evaluation of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care (PriCARE) Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110236
• Other study ID #: 19-016283
• Status: Completed
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: August 4, 2022

Study information

• Verified date: March 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of the enhanced PriCARE intervention in improving parenting capacity, decreasing child behavior problems, and reducing risk of child maltreatment at several primary care clinics in Philadelphia and 2 primary care clinics in North Carolina.

Description:

Child behavioral concerns are common among families served by Children's Hospital of Philadelphia (CHOP) and University of North Carolina (UNC) pediatric primary care centers. To address this, Child Adult Relationship Enhancement in Pediatric Primary Care (PriCARE) was developed. PriCARE has been evaluated in primary care centers at CHOP and UNC with promising findings with regards to reductions in child behavioral problems. The PriCARE curriculum has now been enhanced with strategies to increase participant engagement, retention of skills, and attendance. Efficacy of this enhanced PriCARE curriculum has not yet been evaluated. Nor has the impact of the PriCARE intervention on child maltreatment risk been explored.

The primary objective of this study is to evaluate the efficacy of the enhanced PriCARE program to improve parenting capacity as measured by the Parenting Scale total score and 3 sub-scales.

The secondary objectives are to:

1. Measure the impact of PriCARE on parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory intensity and problems scales.

2. Measure the impact of PriCARE on the quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding.

3. Measure the impact of PriCARE on the risk of child maltreatment as measured by the Child Abuse Potential Inventory.

4. Identify and describe predictors of attendance in PriCARE groups.

5. Identify and describe modifiers of the efficacy of PriCARE including but not limited to caregiver and child demographics.

6. Assess caregivers' perceptions of the efficacy of PriCARE on improving parenting skills and child behavior as measured by the Therapeutic Attitude Inventory (TAI).

7. Develop and pilot a new PriCARE Positive Discipline Module.

8. Collect pilot data on added benefit of completing the PriCARE Positive Discipline Module.

The investigators will perform a randomized controlled trial (RCT) of the effectiveness of the enhanced PriCARE on objectives listed above among 2- to 6-year-old children and their parents at several CHOP Primary Care Centers and two University of North Carolina primary care sites. The investigators intend to randomize up to 119 child-caregiver pairs (238 subjects) to receive PriCARE immediately plus usual treatment (intervention group) and up to 119 child-parent pairs (238 subjects) to receive PriCARE at a later time plus usual treatment (control group) for a total of up to 238 child-caregiver pairs (476 subjects). All child-caregivers pairs randomized to the control group will be placed on a waitlist and offered PriCARE after completion of data collection. Child maltreatment risk, parenting attitudes and skills, child behavior, and quality of the child-caregiver relationship will be measured at baseline (time 1) and approximately 8-17 weeks after randomization (time 2) for both the intervention and control groups. The follow up interview will also include a brief satisfaction questionnaire for participants randomized to the intervention group. For the subgroup of participants who complete the Positive Discipline Module, these measurements will be repeated approximately 2-4 weeks after completion of the Positive Discipline intervention (time 3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: August 4, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• Caregiver is 18 years or older

• Caregiver is English speaking

• Caregiver is legal guardian of child and provides informed consent

• Caregiver has cellular phone with text messaging capacity

• Caregiver is available for scheduled times PriCARE hosts groups

• Child is 2-6 years old

• Caregiver must have the appropriate technological tools and access to participate when in-person sessions are not available

• Child attends one of the CHOP primary care sites in Pennsylvania or one of two University of North Carolina (UNC Children's Primary Care and UNC Pediatrics at Panther Creek) primary care sites

Exclusion Criteria:

• Caregiver has already completed the PriCARE program

• Child has already received a behavioral health diagnosis or is already receiving individualized behavior health therapy or associated medication for Oppositional Defiance Disorder, Conduct Disorder, or Attention- Deficit/Hyperactivity Disorder

• Child is being evaluated for or has been diagnosed with autism

• Child has a cognitive age less than 2 years old as determined by screening questions and/or the referring clinician.

• Child has caused physical injuries, such as bruises or cuts, more than once and on purpose to their caregiver, him/herself, or other children or people

Related Conditions & MeSH terms

• Child Behavior Problem
• Parent-Child Relations
• Problem Behavior

Intervention

Behavioral:
• PriCARE
PriCARE is a group caregiver training program designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. Sessions occur in the primary care clinic or virtually. PriCARE uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches skills for giving effective commands in order to set age-appropriate limits and increase compliance. PriCARE includes a stress education section that contextualizes the use of these skills with the types of behaviors and problems exhibited by many children living with psychosocial adversity and familial stress. Caregivers are encouraged to practice the skills with their child in between sessions. Since PriCARE's initial and successful pilot, the intervention has been enhanced in order to increase engagement and effectiveness.
• Positive Discipline Module
The PriCARE Positive Discipline Module is a pilot group caregiver training program designed to teach caregivers positive discipline techniques, including appropriate timeout procedures. The sessions are offered in the primary care setting or virtually. This training will supplement the content of the main PriCARE intervention and provide caregivers with skills for addressing difficult behaviors not reduced through positive attention and strategic ignoring. This module will be offered to a subset of CHOP participants who were randomized to the intervention arm, successfully completed the main study interviews, and attended at least 4 out of the 6 PriCARE sessions.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Annie E. Casey Foundation, The Pew Charitable Trusts

Country where clinical trial is conducted

United States, 

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the Parenting Scale (PS) score from time 2 to time 3	Change in PS from time 2 to time 3 will be measured in the subset of CHOP participants completing the Positive Discipline Module. PS is a 30-item questionnaire that assesses dysfunctional parenting discipline strategies. Participants respond to various hypothetical situations with a 7-point Likert scale, where 7 is the "ineffective" end of the scale and a lower overall score indicates more effective parenting. There are 3 scale factors: 1) laxness, 2) over-reactivity, and 3) verbosity. Some items are unrelated to any of these 3 factors. The 11 Laxness items relate to permissive discipline, lack of rule reinforcement and providing positive consequences for misbehaviors. The 10 Over-Reactivity items reflect anger, irritability or meanness. The 7 Verbosity items suggest longer verbal responses such as talking when talking is ineffective. All item responses are averaged to compute the total score. Each factors' items are averaged to compute the factor scores.	8-17 weeks (time 2) to 16-30 weeks (time 3)
Other	Change in the Eyberg Child Behavior Inventory (ECBI) score from time 2 to time 3	Change in ECBI scores from time 2 to time 3 will be measured in the subset of CHOP participants completing the Positive Discipline Module. The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years old. 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.	8-17 weeks (time 2), 16-30 weeks (time 3)
Other	Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 2 to time 3	Change in DPICS scores from time 2 to time 3 will be measured in the subset of CHOP participants completing the Positive Discipline Module. Each dyad is observed in 3 standard situations that involve varying levels of parental control and display dyadic interactions targeted by PriCARE: child-led play, caregiver-led play, clean-up. The coding manual has definitions, examples, and guidelines for deciding how to code the 24 standard caregiver and child behaviors. The interactions are video-recorded and coded by a blinded research assistant. Zero, or not observed, is the minimum for all behaviors. The total score is the sum of the coded behaviors within each category, thus there is no set maximum. A second research assistant re-codes 25% of randomly selected videos to check for coding reliability. Reliability will be assessed using % agreement, intraclass correlations, and Cohen's kappa. Comparing pre- and post-intervention videos will demonstrate caregiver and child behavior changes.	8-17 weeks (time 2), 16-30 weeks (time 3)
Other	Therapeutic Attitudes Inventory (TAI) at time 3	The investigators will assess caregivers' perceptions of the efficacy of PriCARE on improving parenting skills and child behavior as measured by the TAI at time 3 for the subset of participants completing the Positive Discipline Module. The TAI is a brief 10-question satisfaction measure of parent training and parent-child treatments. Questions are answered on a 5-point Likert scale with 1 indicating the lowest ("nothing", "much worse than before", "much less confident", etc.) and 5 indicating the highest ("very many useful techniques", "very much better than before", "more confident", etc.). Responses are added together and greater TAI total scores indicate greater levels of participant satisfaction. The potential scores range from 10-50.	16-30 weeks (time 3)
Other	Change in the Child Abuse Potential Inventory (CAPI) score from baseline to time 2 to time 3	CAPI change scores from time 2 to 3 will be measured in subjects participating in the Positive Discipline Module. CAPI, a 160-item survey, measures traits & parenting styles typical of known physical child abusers. Each item has a weighted value based on if agree vs. disagree is chosen and then the values are summed. Child physical abuse scores range from 0-486 with higher scores indicating the caregiver has traits similar to those of known child abusers and has a higher risk of abuse. Ranges for factor scales are: distress (0-261), rigidity (0-64), unhappiness (0-69), problems with child and self (0-30), problems with family (0-38), problems with others (0-24) Higher factor scores imply higher symptom levels. Three validity scales and ranges are: lie (0-18), random (0-18), inconsistency (0-20). Ego-strength score ranges from 0-40 with higher score indicating more emotional stability. Loneliness score ranges from 0-15; higher score means more isolation.	8-17 weeks (time 2), 16-30 weeks (time 3)
Primary	Change in the Parenting Scale (PS) score from time 1 to time 2	The primary objective of the study is to evaluate the efficacy of the enhanced PriCARE program to improve parenting capacity as measured by the Parenting Scale (PS), a 30-item questionnaire that assesses dysfunctional parenting discipline strategies. Participants respond to various hypothetical situations with a 7-point Likert scale, where 7 is the "ineffective" end of the scale and a lower overall score indicates more effective parenting. There are 3 scale factors: 1) laxness, 2) over-reactivity, and 3) verbosity. Some items are unrelated to any of these 3 factors. The 11 Laxness items relate to permissive discipline, lack of rule reinforcement and providing positive consequences for misbehaviors. The 10 Over-Reactivity items reflect anger, irritability or meanness. The 7 Verbosity items suggest longer verbal responses such as talking when talking is ineffective. All item responses are averaged to compute the total score. Each factors' items are averaged to compute the factor scores	Baseline (time 1), 8-17 weeks (time 2)
Secondary	Change in the Eyberg Child Behavior Inventory (ECBI) score from time 1 to time 2	The investigators will assess the efficacy of the enhanced PriCARE on decreasing caregiver-reported child behavior problems as measured by the ECBI. The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years old. 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.	Baseline (time 1), 8-17 weeks (time 2)
Secondary	Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 1 to time 2	Investigators will assess the efficacy of enhanced PriCARE on impacting the quality of the caregiver-child relationship with the DPICS. Each dyad is observed in 3 standard situations that involve varying levels of parental control and display dyadic interactions targeted by PriCARE: child-led play, caregiver-led play, clean-up. The coding manual has definitions, examples, and guidelines for deciding how to code the 24 standard caregiver and child behaviors. The interactions are video-recorded and coded by a blinded research assistant. Zero, or not observed, is the minimum for all behaviors. The total score is the sum of the coded behaviors within each category, thus there is no set maximum. A second research assistant re-codes 25% of randomly selected videos to check for coding reliability. Reliability will be assessed using % agreement, intraclass correlations, and Cohen's kappa. Comparing pre- and post-intervention videos will demonstrate caregiver and child behavior changes.	Baseline (time 1), 8-17 weeks (time 2)
Secondary	Change in the Child Abuse Potential Inventory (CAPI) score from time 1 to time 2	CAPI change scores from time 1 to time 2 will be measured. CAPI, a 160-item survey, measures traits & parenting styles typical of known physical child abusers. Each item has a weighted value based on if agree vs. disagree is chosen and then the values are summed. Child physical abuse scores range from 0-486 with higher scores indicating caregiver has traits similar to those of known child abusers and has a higher risk of abuse. Ranges for factor scales are: distress (0-261), rigidity (0-64), unhappiness (0-69), problems with child and self (0-30), problems with family (0-38), problems with others (0-24) Higher factor scores imply higher symptom levels. Three validity scales and ranges are: lie (0-18), random (0-18), inconsistency (0-20). Ego-strength score ranges from 0-40 with higher score indicating more emotional stability. Loneliness score ranges from 0-15; higher score means more isolation.	Baseline (time 1), 8-17 weeks (time 2)
Secondary	Therapeutic Attitudes Inventory (TAI)	The investigators will assess caregivers' perceptions of the efficacy of PriCARE on improving parenting skills and child behavior as measured by the TAI. The TAI is a brief 10-question satisfaction measure of parent training and parent-child treatments. Questions are answered on a 5-point Likert scale with 1 indicating the lowest ("nothing", "much worse than before", "much less confident", etc.) and 5 indicating the highest ("very many useful techniques", "very much better than before", "more confident", etc.). Responses are added together and greater TAI total scores indicate greater levels of participant satisfaction. The potential scores range from 10-50.	8-17 weeks (time 2)