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Completed

NCT Number: NCT05938998

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

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.

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Key information

Conditions

Burden, Caregiver Abnormalities, Multiple Behavior Behavioral Symptoms Caregiver Burden Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yoga; Support Group

Behavioral

BEHAVIORAL: Group Exercise Sessions- Yoga. BEHAVIORAL: Social Support Sessions

Primary outcomes

  1. Recruitment

    Time frame: Baseline

    We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire.

  2. Session Attendance

    Time frame: 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.

  3. Mean Number of Sessions Attended

    Time frame: From baseline to 12 weeks

    Mean number of sessions attended out of 12 possible sessions

  4. Retention

    Time frame: Weeks 1-12 of intervention

    Calculated as percentage of participants who completed the out of those who enrolled

  5. Acceptability

    Time frame: 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 outcomes

  1. Perceived Stress Scale Score

    Time frame: 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.

  2. ug/dL Salivary Cortisol

    Time frame: 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.

  3. The Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: 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.

  4. Modified Caregiver Strain Index

    Time frame: 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.

  5. The Family Empowerment Scale

    Time frame: 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.

  6. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  7. Physical Activity

    Time frame: 12 weeks

    Moderate to Vigorous Physical Activity and sedentary activity minutes per day assessed by 7 day accelerometer protocol

  8. Body Mass Index

    Time frame: 12 weeks

    Body Mass index (body weight in kilograms per height in meters squared) across 12 weeks

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Acronym: CareWell

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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