Improving Access to a Primary Care Based Positive Parenting Program
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2017
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedStudy Start
First participant enrolled
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedOctober 22, 2019
October 1, 2019
1.7 years
March 2, 2017
October 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Program Adoption
mean number of sessions attended
6-12 weeks
Secondary Outcomes (3)
Child Behavior
0 weeks and 6-12 weeks
Dysfunctional Parenting Behaviors
0 weeks and 6-12 weeks
Dysfunctional Parenting Attitudes
0 weeks and 6-12 weeks
Study Arms (3)
CARE
ACTIVE COMPARATORThe parent-child dyads in the CARE arm will receive the standard CARE program.
CARE plus peer mentor
EXPERIMENTALThe parent-child dyads in the CARE plus peer mentor arm will receive the CARE program that is delivered with the peer mentor.
Control
NO INTERVENTIONWait list control
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- year old child at UNC Children's Primary Care Clinic and their parent
- English speaking
You may not qualify if:
- child is developmentally younger than 2 years old
- child is already received mental health services for behavioral problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Related Publications (1)
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.
PMID: 31809392DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Samantha Schilling, MD, MSHP
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The therapists and the parents will not be blinded to group because they will be providing and receiving the intervention. The investigators who are collecting the data will be blinded to arm.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2017
First Posted
March 10, 2017
Study Start
September 20, 2017
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
October 22, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
We do not plan to share the data with other researchers.