NCT03077321

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

March 2, 2017

Last Update Submit

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 COMPARATOR

The parent-child dyads in the CARE arm will receive the standard CARE program.

Behavioral: CARE

CARE plus peer mentor

EXPERIMENTAL

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

Control

NO INTERVENTION

Wait 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 plus peer mentor
CAREBEHAVIORAL

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.

CARE

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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.

Study Officials

  • Samantha Schilling, MD, MSHP

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

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
Model Details: RCT 1:1:1
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.

Locations