Pilot of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care

NCT04110236 | Completed

• 1 other identifier: 19-016283
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Child Behavior Problem; Parent-Child Relations

Keywords

Child behavior problems; Caregiver child relationship; Primary care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the Eyberg Child Behavior Inventory (ECBI) score from time 1 to time 2

  Baseline (time 1), 8-17 weeks (time 2)

• Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 1 to time 2

  Baseline (time 1), 8-17 weeks (time 2)

• Change in the Child Abuse Potential Inventory (CAPI) score from time 1 to time 2

  Baseline (time 1), 8-17 weeks (time 2)

• Therapeutic Attitudes Inventory (TAI)

  8-17 weeks (time 2)

Other Outcomes (5)

• Change in the Parenting Scale (PS) score from time 2 to time 3

  8-17 weeks (time 2) to 16-30 weeks (time 3)

• Change in the Eyberg Child Behavior Inventory (ECBI) score from time 2 to time 3

  8-17 weeks (time 2), 16-30 weeks (time 3)

• Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 2 to time 3

  8-17 weeks (time 2), 16-30 weeks (time 3)

Study Arms (4)

Immediate PriCARE

EXPERIMENTAL

Caregiver-child dyads assigned to the immediate PriCARE group will receive the PriCARE intervention as soon as possible plus usual treatment. The intervention will last approximately 6-8 weeks. Each group will have approximately 4-13 participants and 1-2 facilitators and will meet 6 times for 1-2 hours per session. Parents are expected to practice the skills they learn with their children between sessions.

Behavioral: PriCARE

Delayed PriCARE

NO INTERVENTION

The delayed PriCARE group will not receive the PriCARE intervention until after their data collection for this study is complete (in 3-6 months). In addition, they will be immediately offered usual treatment. 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.

Immediate PriCARE Positive Discipline Module

EXPERIMENTAL

A subset of participants (up to 40 caregiver-child pairs) who were assigned to the immediate PriCARE group will be offered to participate in the PriCARE Positive Discipline Module if they attended at least 4 PriCARE sessions and completed both main study interviews. If they are randomized to the immediate PriCARE Positive Discipline group, they will attend an additional 4-6 sessions 4-6 weeks after completion of the 6-week PriCARE intervention. This module teaches techniques related to behavior reward charts, appropriate timeout protocol, and other positive discipline techniques for handling persistent behaviors not addressed by the other PriCARE skills.

Behavioral: Positive Discipline Module

Delayed PriCARE Positive Discipline Module

NO INTERVENTION

The delayed Positive Discipline group will not receive the Positive Discipline Module intervention until after their third interview data collection is complete (in 2-3 months). In addition, they will be immediately offered usual treatment. 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.

Interventions

PriCARE BEHAVIORAL

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.

Also known as: Child Adult Relationship Enhancement in Primary Care

Immediate PriCARE

Positive Discipline Module BEHAVIORAL

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.

Also known as: PriCARE Positive Discipline Module

Immediate PriCARE Positive Discipline Module

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Annie E. Casey Foundation: collaborator
• The Pew Charitable Trusts: collaborator

Study Sites (2)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (34)

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• Kiely J, DePaul E, Rojas S, Cortes S, Schilling S, Dougherty S, Wood JN. Evaluation of Virtual Enhanced Child Adult Relationship Enhancement in Primary Care Intervention. J Dev Behav Pediatr. 2024 Sep-Oct 01;45(5):e439-e447. doi: 10.1097/DBP.0000000000001292. Epub 2024 Jun 21.

  PMID: 39413305 DERIVED

MeSH Terms

Interventions

Primary Health Care

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Joanne Wood, MD, MSHP

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study team member who will administer the follow-up study interviews will remain blinded to the group status throughout the duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: December 3, 2019
• Primary Completion: June 22, 2022
• Study Completion: August 4, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)