Improving Access to a Primary Care Based Positive Parenting Program

NCT ID: NCT03077321

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2019-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Program Implementation Child Behavior Problem Positive Parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT 1:1:1
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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CARE

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

Group Type ACTIVE_COMPARATOR

CARE

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

CARE plus Peer Mentor

Intervention Type BEHAVIORAL

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.

Control

Wait list control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samantha Schilling, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31809392 (View on PubMed)

Other Identifiers

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17-0545

Identifier Type: -

Identifier Source: org_study_id

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