Improving Access to a Primary Care Based Positive Parenting Program

This is a randomized clinical trial of the impact of incorporating a peer mentor into a primary care based group parenting program on increasing program participation by parents and improving program outcomes.

Study Overview

• Status: Completed
• Conditions: Child Behavior Problem; Positive Parenting; Program Implementation
• Intervention / Treatment: Behavioral: CARE; Behavioral: CARE plus Peer Mentor

Detailed Description

The investigators will perform a randomized controlled trial of the impact of Child Adult Relationship Enhancement (CARE) plus peer mentor on increasing program adoption, acceptability, and appropriateness among 2-6 year old children and their parents at UNC Children's Primary Care Clinic. The investigators will also examine the effectiveness of CARE plus peer mentor on dysfunctional parenting and child behavior problems. Participants will be randomized to CARE plus peer mentor or standard CARE. Program attendance, acceptability, and appropriateness will be measured upon completion of the 6-week program. Dysfunctional parenting and child behavior will be measured at baseline and 6 weeks. The investigators will conduct semi-structured interviews among a sample of parents (~20-30) in order to understand the impact of the peer mentors on program implementation, as well as barriers and facilitators to program initiation and long-term participation.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 2-6 year old child at UNC Children's Primary Care Clinic and their parent
• English speaking

Exclusion Criteria:

• child is developmentally younger than 2 years old
• child is already received mental health services for behavioral problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CARE; The parent-child dyads in the CARE arm will receive the standard CARE program.	Behavioral: CARE; CARE involves 6 weekly 90-minute sessions administered to 6-10 parents by 2 therapists. The initial phase focuses on developing parenting skills aimed at increasing attention to children's pro-social behaviors while ignoring minor attention seeking misbehaviors. The second phase teaches techniques for giving children effective commands in order to set age-appropriate limits and increase compliance. Children do not attend the training but parents are expected to practice the skills with their children between sessions.
Experimental: CARE plus peer mentor; The parent-child dyads in the CARE plus peer mentor arm will receive the CARE program that is delivered with the peer mentor.	Behavioral: CARE plus Peer Mentor; A parent who has completed the standard CARE program will be recruited to be a peer mentor. The peer mentor will attend the CARE training for group leaders and will also be trained in motivational interviewing. These skills will then be used strategically in weekly phone discussions between the peer mentor and parent about practicing the CARE parenting skills in the home setting and planning for attending the 6 training sessions. The parent mentor will co-facilitate the CARE groups in the peer mentor arm along with 2 additional CARE therapists. The peer mentor will also call the parents in the peer mentor arm before each session to discuss progress on homework, and to address barriers for program attendance.
No Intervention: Control; Wait list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Adoption	mean number of sessions attended	6-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Behavior	Child behavior as measured by the Eyberg Child Behavior Inventory. The Eyberg Child Behavior Inventory (ECBI) is a 36 item paper-and-pencil rating scales completed by parents that assesses the severity of conduct problems in children as well as the extent to which parents find the behaviors troublesome. It assesses the frequency of disruptive behaviors occurring in the home setting. It provides an Intensity Raw Score and a Problem Raw Score. The intensity scale (range 36-252) and the problem scale (range 0-36). In both cases higher values indicate more externalizing behaviors.	0 weeks and 6-12 weeks
Dysfunctional Parenting Behaviors	Dysfunctional parenting Behaviors as measured by the Parenting Scale.The Parenting Scale is a 30-item parent-report instrument that measures dysfunctional parenting practices for parents of young children. Specifically, the Parenting Scale measures laxness (permissive, inconsistent discipline); over-reactivity (harsh, emotional, authoritarian discipline); and hostility (use of verbal or physical force). It provides a total score, and three sub scale scores (laxness, over-reactivity, and hostility), each with a range of 1-7. Higher scores are indicative of more dysfunctional parenting.	0 weeks and 6-12 weeks
Dysfunctional Parenting Attitudes	Dysfunctional parenting attitudes as measured by the Adult Adolescent Parenting Inventory-2.The AAPI-2 is a 40 item self-report measure. The AAPI-2 assesses parenting attitudes along 5 dimensions: (1) inappropriate expectations of children, (2) parental lack of empathy towards children'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 children's power and independence. Raw scores with a range from 1 to 10 are provided for each dimension and translated into risk categories: high (1-3), medium (4-7), low(8-10).	0 weeks and 6-12 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Samantha Schilling, MD, MSHP, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Schilling S, Ritter V, Wood JN, Fine J, Zolotor AJ. Child-Adult Relationship Enhancement in Primary Care: A Randomized Trial of a Skill-Based Parent Training with Parent Mentor Adaptation. J Dev Behav Pediatr. 2020 May;41(4):272-280. doi: 10.1097/DBP.0000000000000759.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: 17-0545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share the data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No