Burden, CaregiverCareWellNCT05938998
Social Support and Stress Reduction for Caregivers of Young Adults With IDD
A study testing Yoga; Support Group in people with Burden, Caregiver, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burden, Caregiver
- What is being tested?
- Yoga; Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) caregiver of a young adult with IDD 2) self-reported ability to participate in a yoga class with no contraindications to participation.
Who cannot join
- 1) Actively participating in another health lifestyles interventional research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the 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.
- Conditions
- Burden, Caregiver
- Being tested
- Yoga; Support Group
- Keywords
- Caregiver, Down syndrome, Intellectual Disability, Parent, Stress
- Medical subject headings
- Caregiver Burden, Down Syndrome, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga; Support GroupBehavioural
BEHAVIORAL: Group Exercise Sessions- Yoga. BEHAVIORAL: Social Support Sessions
| Study group | Role | What they receive |
|---|---|---|
| Social Support and Yoga | Experimental | 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. Receives: Behavioral: Yoga; Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire.
Measured: 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.
Measured: Weeks 1-12 of intervention
Mean Number of Sessions Attended
Mean number of sessions attended out of 12 possible sessions
Measured: From baseline to 12 weeks
Retention
Calculated as percentage of participants who completed the out of those who enrolled
Measured: Weeks 1-12 of intervention
Acceptability
Number of Participants who Found the Intervention Helpful. Semi-structured interviews were conducted with each caregiver to assess satisfaction with the intervention components.
Measured: Between Weeks 12-14
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Physical Activity
Moderate to Vigorous Physical Activity and sedentary activity minutes per day assessed by 7 day accelerometer protocol
Measured: 12 weeks
Body Mass Index
Body Mass index (body weight in kilograms per height in meters squared) across 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start31 Mar 2023
- Primary completion30 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Burden, CaregiverStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Amy Bodde, PhD, MPH, University of Kansas Medical Center
- Investigators
- Amy Bodde, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938998
- Sponsor's protocol ID
- STUDY00149679
- Other IDs
- 3KL2TR002367-08S1
- Acronym
- CareWell
- Status last verified
- Aug 2025
- First submitted
- 29 Jun 2023
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Support and Stress Reduction for Caregivers of Young Adults With IDD
- ClinicalTrials.gov ID
- NCT05938998
- Acronym / sponsor ID
- CareWell / STUDY00149679
- Conditions
- Burden, Caregiver
- Keywords
- Caregiver, Down syndrome, Intellectual Disability, Parent, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social Support and Yoga | Experimental | Behavioral: Yoga; Support GroupThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) caregiver of a young adult with IDD 2) self-reported ability to participate in a yoga class with no contraindications to participation.
Key exclusion criteria (1 listed)
- 1) Actively participating in another health lifestyles interventional research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga; Support GroupBEHAVIORAL: Group Exercise Sessions- Yoga. BEHAVIORAL: Social Support Sessions | Behavioural | Social Support and Yoga |
Primary outcome
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.
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.
Mean Number of Sessions Attended
Time frame: From baseline to 12 weeks
Mean number of sessions attended out of 12 possible sessions
Retention
Time frame: Weeks 1-12 of intervention
Calculated as percentage of participants who completed the out of those who enrolled
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.
8 secondary outcomes
Perceived Stress Scale Score
Time frame: 12 weeks
ug/dL Salivary Cortisol
Time frame: 12 weeks
The Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 12 weeks
Modified Caregiver Strain Index
Time frame: 12 weeks
The Family Empowerment Scale
Time frame: 12 weeks
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 weeks
Physical Activity
Time frame: 12 weeks
Body Mass Index
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Bodde, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga; Support Group in people with Burden, Caregiver, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.