- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07303062
Adolescent Mental Health Parenting Program for Child-Adult Relationship Enhancement (AMP-CARE)
Evaluating the Impact of Adolescent Mental Health Parenting Program for Child-Adult Relationship Enhancement (AMP-CARE)
The purpose of this research study is to learn if a parenting program called Adolescent Mental Health Parenting Program for Child Adult Relationship Enhancement (AMP-CARE) can help parents have more confidence in parenting their teen and improve their knowledge about normal teen development and teen mental health. The main questions it aims to answer are:
- Does the AMP-CARE parenting program improve confidence in teen parenting and positive parenting?
- Does the AMP-CARE parenting program improve parent knowledge about mental health?
Researchers will compare participants who complete the parenting program to those who do not.
Participants will:
- Complete 2 surveys, one at the start of the study and one 6 -12 weeks later
- Half of the participants will be randomly picked to attend the 6 virtual AMP-CARE sessions right away.
- The other half will have the opportunity to attend AMP-CARE after they complete the second survey.
Study Overview
Status
Conditions
Detailed Description
In this randomized controlled trial, 60 parents of teens, ages 11-14 years, will be randomized to either AMP-CARE or wait-list control to achieve the following aims:
AIM 1. To measure the impact of AMP-CARE on parent mental health literacy as measured by the Parental Child Mental Health Literacy Questionnaire (PCMHLQ).
AIM 2: To measure the impact of AMP-CARE on parenting self-efficacy as measured by the Parenting Self Efficacy Scale.
AIM 3: To measure the impact of AMP-CARE on promotive parenting practices assessed by the Positive Parenting and Parental Involvement subscales of the Alabama Parenting Questionnaire.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Cary, North Carolina, United States, 27519
- UNC Pediatrics at Panther Creek
-
Contact:
- Priyanka Rao, MD
- Phone Number: 919-481-4997
- Email: priyanka_rao@med.unc.edu
-
Chapel Hill, North Carolina, United States, 27517
- UNC Children's Primary and Specialty Care at Carolina Pointe II
-
Contact:
- Katherine Jordan, MD
- Phone Number: 984-974-6669
- Email: katherine_jordan@med.unc.edu
-
Principal Investigator:
- Yasamin Sanii, MD
-
Sub-Investigator:
- Samantha Schilling, MD, MSPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent or guardian of teen age 11-14 years
- Receiving primary care at selected study sites
- English speaking
Exclusion Criteria:
- Parents of children with severe mental illness (indicated by psychiatric hospitalization in the last 12 months or previous diagnosis of psychosis)
- Parents of children with severe developmental delay (indicated by prior diagnosis of severe neurodevelopmental impairment, global developmental delay, severe expressive language delay)
- Not available at time group is scheduled
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AMP-CARE
Parents will attend the 6 virtual sessions with a group of about 5-10 parents and 2 facilitators.
The AMP-CARE group sessions are held for about 90 minutes once per week.
Sessions include didactics, role playing, vignettes, and weekly home practice to build positive parenting techniques.
|
The goals of AMP-CARE are to teach parents how to form a positive relationship with their teen and to teach about typical adolescent development and mental health.
Each AMP-CARE session will be led by 1 or 2 trainers.
About 4 to 13 parents will attend each virtual session lasting approximately 1.5 hours.
Sessions will be weekly for 6 weeks.
Participants are encouraged to practice the skills learned at AMP-CARE between the sessions.
|
|
No Intervention: Waitlist Control
Parents in the control group will be offered the intervention after completing the second study questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Mental Health Literacy
Time Frame: From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Parent Mental Health Literacy was assessed with 23-item self-report measure, the Parental Child Mental Health Literacy Questionnaire.
Using a 5-pt scale with endpoints of "0=strongly disagree" and "4=strongly agree," parents were asked to indicate their level of agreement with statements related to 5 constructs: mental health recognition, beliefs, knowledge, help-seeking confidence, and fear of stigma.
Scores ranged from 0 to 4. Higher scores indicate greater literacy.
|
From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Self Efficacy
Time Frame: From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Parenting self-efficacy was assessed with the 19-item self-report measure Parenting Self Efficacy Scale.
Using a 5-point scale, parents indicated how frequently states related to their efficacy to develop positive teenager behavior, their efficacy to respond competently to negative teenager behavior, and their monitoring efficacy were true from "1=never" to 5 "always."
Total scores ranged from 1 to 5 with higher scores indicating greater self-efficacy.
|
From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
|
Promotive Parenting Practices
Time Frame: From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Promotive parenting practices were assessed with 16 self-report items from two subscales of Alabama Parenting Questionnaire.
The positive involvement subscale includes 10 items, with a range of possible scores from 10 to 50.
The positive parenting subscale includes 6 items, with a range of possible scores from 6 to 30.
Parents rate the frequency with which each parenting practice occurs in their home from "1=never" to "5=always."
Higher scores indicate more positive parenting.
|
From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Collaborators and Investigators
Investigators
- Study Director: Samantha Schilling, MD MSHP, University of North Carolina, Chapel Hill
- Principal Investigator: Yasamin Sanii, MD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-3652
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adolescent Behavior
-
World Health OrganizationLondon School of Hygiene and Tropical Medicine; University of Ghana; Biomedical... and other collaboratorsRecruitingHealth-Related Behavior | Adolescent Behavior | Adolescent Development | Health Care Seeking BehaviorGhana, Tanzania, Zimbabwe
-
University of CoimbraRecruitingAdolescent Behavior | Adolescent - Emotional ProblemPortugal
-
Seattle Children's HospitalRecruiting
-
Child TrendsUniversity of California, San Francisco; Power to DecideRecruiting
-
Karabuk UniversityCompleted
-
Centerstone Research InstituteActive, not recruitingRisk Reduction | Adolescent Behavior | Adolescent Problem BehaviorUnited States
-
Stanford UniversityRecruitingAdolescent BehaviorUnited States
-
Rhode Island HospitalCompletedSexual Behavior | Adolescent Behavior
-
The University of Texas Medical Branch, GalvestonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Child TrendsUniversity of Maryland; Identity, Inc.Completed
Clinical Trials on Adolescent Mental Health Parenting Program for Child-Adult Relationship Enhancement (AMP-CARE)
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingParent-Child Relations | Child MaltreatmentUnited States