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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burden, Caregiver

Intervention / Treatment
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* Behavioral: Yoga; Support Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social Support and Yoga<br>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<br>* BEHAVIORAL: Group Exercise Sessions- Yoga. BEHAVIORAL: Social Support Sessions<br>|

What is the study measuring?
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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 | 
| Acceptability | Semi-structured interviews will be conducted with each caregiver to assess satisfaction with the intervention components. Interviews will be recorded and transcribed for analysis. | Between Weeks 12-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Perceived Stress Scale | 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. | Change from baseline to 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. | Change from baseline to 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. | Change from baseline to 12 weeks | 
| Modified Caregiver Strain Index | Modified Caregiver Strain Index 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. | Change from baseline to 12 weeks | 
| The Family Empowerment Scale | The Family Empowerment Scale, only subscales family and service systems will be administered, at baseline and 12 weeks. Each subscale scores from 0-60, with a higher score indicating better family empowerment. | Change from baseline to 12 weeks | 
| The Pittsburgh Sleep Quality Index | 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. | Change from baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, Down syndrome, Intellectual Disability, Parent, Stress