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Improving Access to a Primary Care Based Positive Parenting Program

Primary Purpose

Program Implementation, Child Behavior Problem, Positive Parenting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CARE plus Peer Mentor
CARE
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Program Implementation

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

CARE

CARE plus peer mentor

Control

Arm Description

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

The parent-child dyads in the CARE plus peer mentor arm will receive the CARE program that is delivered with the peer mentor.

Wait list control

Outcomes

Primary Outcome Measures

Program Adoption
mean number of sessions attended

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
March 2, 2017
Last Updated
October 18, 2019
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03077321
Brief Title
Improving Access to a Primary Care Based Positive Parenting Program
Official Title
Improving Access to a Primary Care Based Positive Parenting Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Program Implementation, Child Behavior Problem, Positive Parenting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT 1:1:1
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CARE
Arm Type
Active Comparator
Arm Description
The parent-child dyads in the CARE arm will receive the standard CARE program.
Arm Title
CARE plus peer mentor
Arm Type
Experimental
Arm Description
The parent-child dyads in the CARE plus peer mentor arm will receive the CARE program that is delivered with the peer mentor.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Wait list control
Intervention Type
Behavioral
Intervention Name(s)
CARE plus Peer Mentor
Intervention Description
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
Intervention Name(s)
CARE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Program Adoption
Description
mean number of sessions attended
Time Frame
6-12 weeks
Secondary Outcome Measure Information:
Title
Child Behavior
Description
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.
Time Frame
0 weeks and 6-12 weeks
Title
Dysfunctional Parenting Behaviors
Description
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.
Time Frame
0 weeks and 6-12 weeks
Title
Dysfunctional Parenting Attitudes
Description
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).
Time Frame
0 weeks and 6-12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha Schilling, MD, MSHP
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share the data with other researchers.
Citations:
PubMed Identifier
31809392
Citation
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.
Results Reference
derived

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Improving Access to a Primary Care Based Positive Parenting Program

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