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

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.

Study Overview

• Status: Completed
• Conditions: Burden, Caregiver
• Intervention / Treatment: Behavioral: Yoga; Support Group

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Support and Yoga; This is a single arm trial. This arm includes one hour of a guided social support group and one hour of yoga, weekly for 12 total weeks.	Behavioral: Yoga; Support Group; BEHAVIORAL: Group Exercise Sessions- Yoga. BEHAVIORAL: Social Support Sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire.	Baseline
Session Attendance	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.	Weeks 1-12 of intervention
Retention	Calculated as percentage of participants who completed the out of those who enrolled	Weeks 1-12 of intervention
Mean Number of Sessions Attended	Mean number of sessions attended out of 12 possible sessions	From baseline to 12 weeks
Acceptability	Number of Participants who Found the Intervention Helpful. Semi-structured interviews were conducted with each caregiver to assess satisfaction with the intervention components.	Between Weeks 12-14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale Score	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.	12 weeks
ug/dL Salivary Cortisol	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.	12 weeks
The Multidimensional Scale of Perceived Social Support (MSPSS)	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.	12 weeks
Modified Caregiver Strain Index	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.	12 weeks
The Family Empowerment Scale	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.	12 weeks
The Pittsburgh Sleep Quality Index (PSQI)	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.	12 weeks
Physical Activity	Moderate to Vigorous Physical Activity and sedentary activity minutes per day assessed by 7 day accelerometer protocol	12 weeks
Body Mass Index	Body Mass index (body weight in kilograms per height in meters squared) across 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Amy Bodde, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Stress; Caregiver; Down syndrome; Parent; Intellectual Disability
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Behavioral Symptoms; Neurobehavioral Manifestations; Congenital Abnormalities; Neurodevelopmental Disorders; Abnormalities, Multiple; Stress, Psychological; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Caregiver Burden; Intellectual Disability; Down Syndrome; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Organizations; Health Care Economics and Organizations; Yoga; Self-Help Groups
• Other Study ID Numbers: STUDY00149679; 3KL2TR002367-08S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No