Improving the Health of Parents and Their Adolescent and Transition-age Youth With Intellectual and Developmental Disabilities

NCT05986305 | Active Not Recruiting

• 1 other identifier: 23-0739
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 2

Brief Summary

This study will determine the comparative effectiveness of Go Act, a tailored advocacy curriculum versus Peer parent-directed peer learning for increasing parent activation for parents of youth with intellectual and developmental disabilities. Second, it will determine the comparative effectiveness of the two study arms for improving parent and youth health outcomes while assessing whether parent activation serves as a mechanism that mediates their effects on health outcomes.

Conditions

Intellectual Disability

Outcome Measures

Primary Outcomes (3)

• Difference in change in parent activation

  The Parent Patient Activation Measure will be used to capture parent activation on behalf of their child (mean score=70) at 6, 12 and 18 months after intervention. The Parent Patient Activation Measure is a parent self-report 13-item scale with 4-level likert responses and scores ranging from 0 to 100.

  up to18 months after intervention

• Difference in change in youth social functioning- life satisfaction

  Youth social functioning will be assessed using the NIH Patient-Reported Outcomes Measurement Information System for children life satisfaction measure at 6, 12 and 18 months after intervention.

  up to18 months after intervention

• Difference in change in parent depression

  Parent depression will be measured with the 8-item Patient Health Questionnaire at 6, 12 and 18 months after intervention. The Patient Health Questionnaire is scored from 0 to 24.

  up to 18 months after intervention

Secondary Outcomes (10)

• Difference in change in parenting self-efficacy

  up to 18 months after intervention

• Difference in change in shared decision-making

  up to 18 months after intervention

• Difference in change in alliance

  up to 18 months after intervention

• Difference in change in goal attainment

  up to 18 months after intervention

• Difference in change in stress

  up to 18 months after intervention

Study Arms (2)

Go Act

ACTIVE COMPARATOR

Go Act is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period.

Behavioral: Go Act

Peer

ACTIVE COMPARATOR

Peer is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period.

Behavioral: Peer

Interventions

Go Act BEHAVIORAL

Go Act sessions address becoming a parent who can 'Go Act,' caring for one's self as a parent, understanding and managing youth health needs, working with health providers as partners, and working with other service providers such as schools and vocational services. The intervention uses motivational interviewing, story-telling with self-disclosure, psycho-education introduced with a know-want to know-learned strategy, problem-solving, role play, and practice outside of class.

Go Act

Peer BEHAVIORAL

During Peer sessions facilitators lay ground rules for respectful and confidential sharing and encourage group discussion. The group provides a format to make personal connections through shared identity. Participants may discuss strategies for individualized advocacy, so that they learn from the experiences of others.

Peer

Eligibility Criteria

• Age: 11 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parents
• Raising an adolescent or young adult child (age 11-27), with diagnosed or suspected intellectual or developmental disability
• Able to attend group sessions
• Able to give informed consent
• Resident of any state except New York or Illinois due to electronic signature law
• Youth
• Being between the ages of 11 and 27
• Having diagnosed or suspected intellectual or developmental disability

You may not qualify if:

• Parents
• Having evidence of emergency mental health needs

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

The Carolina Institute for Developmental Disabilities

Carrboro, North Carolina, 27510, United States

Location

UNC Adult Psychiatry Clinic

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kathleen C Thomas, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 8, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved Institutional Review Board, Independent Ethics Committee, or Research Ethics Board and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.

Locations

US (2)