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Improving Access to a Primary Care Based Positive Parenting Program

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ClinicalTrials.gov Identifier: NCT03077321
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Program Implementation Child Behavior Problem Positive Parenting Behavioral: CARE plus Peer Mentor Behavioral: CARE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT 1:1:1
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Prevention
Official Title: Improving Access to a Primary Care Based Positive Parenting Program
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

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



Primary Outcome Measures :
  1. Program Adoption [ Time Frame: 6-12 weeks ]
    mean number of sessions attended


Secondary Outcome Measures :
  1. Child Behavior [ Time Frame: 0 weeks and 6-12 weeks ]
    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.

  2. Dysfunctional Parenting Behaviors [ Time Frame: 0 weeks and 6-12 weeks ]
    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.

  3. Dysfunctional Parenting Attitudes [ Time Frame: 0 weeks and 6-12 weeks ]
    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).



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077321


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Samantha Schilling, MD, MSHP University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03077321     History of Changes
Other Study ID Numbers: 17-0545
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share the data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms