Clinical trial NCT05986305: Improving the Health of Parents and Their Adolescent and Transition-age Youth With Intellectual and Developmental Disabilities
Official title: Improving the Health of Parents and Their Adolescent and Transition-age Youth With Intellectual and Developmental Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-08-14
Enrollment: 404
Sex: ALL
Minimum age (years): 11
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A well-functioning system of care should provide a broad array of services that can support families with a child with complex health care needs. Nonetheless, adolescents and transition age youth with intellectual and developmental disabilities experience rates of unmet need for health care up to 6 times higher than others resulting in poor health and quality of life for themselves and their families.

The system of care approach has achieved positive impacts for children with intellectual and developmental disabilities and their families, but updates call for training to help parents develop advocacy skills on behalf of their children. Prior research on diverse populations indicates that parent advocacy skills are a promising target for increasing parent self-efficacy, which in turn is associated with better parent and youth health outcomes. Parent advocacy skills can be increased through a psycho-educational advocacy skills curriculum or through parent-directed peer-learning. However, the comparative effectiveness of these two strategies for families raising youth with intellectual and developmental disabilities is not yet known.

This study has two objectives. First, it 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.

Eligibility criteria: Inclusion Criteria:

Parents

* Bringing their adolescent or young adult child (age 11-27), with diagnosed or suspected intellectual or developmental disability, to one of the participating clinics
* Able to attend group sessions
* Able to give informed consent
* Resident of North Carolina Youth
* Being between the ages of 11 and 27
* Having diagnosed or suspected intellectual or developmental disability
* Being present for a visit at one of the study clinics

Exclusion Criteria:

Parents

* Having evidence of emergency mental health needs
* Not willing to be recorded

Primary outcomes:
measure: Difference in change in parent activation
timeFrame: up to18 months after intervention
measure: Difference in change in youth social functioning- life satisfaction
timeFrame: up to18 months after intervention
measure: Difference in change in parent depression
timeFrame: up to 18 months after intervention
Secondary outcomes:
measure: Difference in change in parenting self-efficacy
timeFrame: up to 18 months after intervention
measure: Difference in change in shared decision-making
timeFrame: up to 18 months after intervention
measure: Difference in change in alliance
timeFrame: up to 18 months after intervention
measure: Difference in change in goal attainment
timeFrame: up to 18 months after intervention
measure: Difference in change in stress
timeFrame: up to 18 months after intervention
measure: Difference in change in observed parent activation
timeFrame: up to18 months after intervention
measure: Difference in change in youth social functioning- meaning & purpose
timeFrame: up to 18 months after intervention
measure: Difference in change in youth unmet need for care
timeFrame: up to 18 months after intervention
measure: Difference in change in youth psychiatric crisis care use
timeFrame: up to 18 months after intervention
measure: Difference in change in number of inpatient psychiatric stays
timeFrame: up to 18 months after intervention
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Family Medicine at the Mountain Area Health Education Center
state: North Carolina
city: Carrboro
country: United States
facility: The Carolina Institute for Developmental Disabilities
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Adult Psychiatry Clinic
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kathleen C Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
References: