Social Support and Stress Reduction for Caregivers of Young Adults With IDD

Not Applicable

Completed

• Conditions: Burden, Caregiver

• Registration Number: NCT05938998
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The objective of this study is to evaluate the feasibility and stress reduction impacts of a yoga and support group intervention on caregivers of individuals with intellectual and developmental disabilities.

Detailed Description

This is a single arm longitudinal trial. We will recruit up to 40 caregivers of young adults with intellectual and developmental disabilities (IDD). This is a 12-week social support, resources, and stress reduction intervention delivered in person to a group of caregivers of young adults IDD. Participants will be asked to attend one 2 hour group session each week. All sessions will have a 1-hour discussion on resources and social support and 1-hour of yoga. All yoga sessions will be taught by 200 Registered Yoga Teacher certified instructors. Outcome assessments will be collected at baseline and after the 12-week intervention.

Study Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-11
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-30
• Results First Submitted: 2025-07-28
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-22
• Last Update Submitted: 2025-08-22
• Results First Posted: 2025-09-12
• Last Update Posted: 2025-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1) caregiver of a young adult with IDD 2) self-reported ability to participate in a yoga class with no contraindications to participation.

Exclusion Criteria

• 1) Actively participating in another health lifestyles interventional research study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recruitment	Baseline	We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire.
Session Attendance	Weeks 1-12 of intervention	The group session leaders will record attendance at weekly sessions. The participants will only be considered present if they complete the entire 2-hour session. The outcome variable will be the number of sessions attended (count) and percentage of attendance out of the total 12 scheduled sessions.
Mean Number of Sessions Attended	From baseline to 12 weeks	Mean number of sessions attended out of 12 possible sessions
Retention	Weeks 1-12 of intervention	Calculated as percentage of participants who completed the out of those who enrolled
Acceptability	Between Weeks 12-14	Number of Participants who Found the Intervention Helpful. Semi-structured interviews were conducted with each caregiver to assess satisfaction with the intervention components.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale Score	12 weeks	The Perceived Stress Scale will be administered at baseline and post intervention. Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.
ug/dL Salivary Cortisol	12 weeks	Cortisol will be used of measure physiologic stress collected at baseline and post intervention, self-collected using saliva swabs. Test kits can detect salivary cortisol in the range between 0.012-3.000 ug/dL.
The Multidimensional Scale of Perceived Social Support (MSPSS)	12 weeks	The Multidimensional Scale of Perceived Social Support (MSPSS) will be given at baseline and post intervention. This measure scores from 12-84 with the higher score indicating more perceived support.
Modified Caregiver Strain Index	12 weeks	Modified Caregiver Strain Index (MCSI) will be given to participants at baseline and post intervention. Scoring ranges from 26 to 0; a higher score indicates a higher level of caregiver strain.
The Family Empowerment Scale	12 weeks	The Family Empowerment Scale subscales for family and service systems will be administered, at baseline and 12 weeks. Each subscale (family subscale and service subscale) scores from 0-60, with a higher score indicating better family empowerment.
The Pittsburgh Sleep Quality Index (PSQI)	12 weeks	The Pittsburgh Sleep Quality Index will be administered at baseline and post intervention. Overall scores range from 0 to 21, where lower scores denote a healthier sleep quality.
Physical Activity	12 weeks	Moderate to Vigorous Physical Activity and sedentary activity minutes per day assessed by 7 day accelerometer protocol
Body Mass Index	12 weeks	Body Mass index (body weight in kilograms per height in meters squared) across 12 weeks

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States