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| ID | Type | Description | Link |
|---|---|---|---|
| 3KL2TR002367-08S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga; Support Group | Behavioral | BEHAVIORAL: Group Exercise Sessions- Yoga. BEHAVIORAL: Social Support Sessions |
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| 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 |
| Mean Number of Sessions Attended | Mean number of sessions attended out of 12 possible sessions | From baseline to 12 weeks |
| Retention | Calculated as percentage of participants who completed the out of those who enrolled | 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. | Between Weeks 12-14 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Bodde, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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This was a single-arm pilot trial, therefore all participants were assigned to the intervention arm.
From all recruitment methods, 25 caregivers were interested in the intervention and completed the eligibility questionnaire. All 25 were eligible, however the study team was unable to reach 3 participants and 2 more decided not to participate, resulting in a recruitment rate of 80% and an average of 4 participants recruited per month of recruitment. One participant formally dropped out of the study and 3 participants were unavailable for post-test outcomes measurement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | This is a single arm trial, therefore Arm 1 is the intervention arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | This is a single arm trial, therefore Arm 1 is the intervention arm. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age of participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment | We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire. | 25 participants completed the eligibility questionnaire. All 25 were eligible, however the study team was unable to reach 3 participants and 2 more decided not to participate, resulting in a recruitment rate of 80%. | Posted | Count of Participants | Participants | Baseline |
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From enrollment in the study to the end of measures completion, approximately 14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | This is a single arm trial, therefore Arm 1 is the intervention arm. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | One participant was hospitalized for pneumonia. This was not study related. The participant was discharged and recovered from the illness. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One participant reported injuring their back outside of the study. They did not participate in one yoga class but then continued afterward with no problems. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Bodde | University of Kansas Medical Center | 913-588-7983 | abodde@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2023 | Jul 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| D004314 | Down Syndrome |
| D008607 | Intellectual Disability |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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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 |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Midwestern United States | Number | Participants |
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| Family caregiver | Family member versus non-family member caregiver | Count of Participants | Participants |
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| Primary | 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. | Posted | Mean | Standard Deviation | sessions attended | Weeks 1-12 of intervention |
|
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| Primary | Mean Number of Sessions Attended | Mean number of sessions attended out of 12 possible sessions | Posted | Mean | Standard Deviation | Sessions attended | From baseline to 12 weeks |
|
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| Primary | Retention | Calculated as percentage of participants who completed the out of those who enrolled | Posted | Count of Participants | Participants | Weeks 1-12 of intervention |
|
|
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| Secondary | 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. | 16 participants were available for outcomes assessment | Posted | Mean | Standard Deviation | Perceived Stress Scale Numeric Score | 12 weeks |
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| Secondary | 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. | 13 participants completed saliva samples at both baseline and 12 weeks. | Posted | Mean | Standard Deviation | ug/dL | 12 weeks |
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| Secondary | 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. | 15 participants returned surveys. | Posted | Mean | Standard Deviation | MSPSS numeric score | 12 weeks |
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| Secondary | 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. | 16 participants completed this survey at both baseline and 12 weeks. | Posted | Mean | Standard Deviation | Numeric score on MCSI measure | 12 weeks |
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| Secondary | 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. | 16 participants were available for this outcome assessment | Posted | Mean | Standard Deviation | Subscales numeric scores | 12 weeks |
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| Secondary | 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. | 14 participants had valid sleep data at baseline and 12 weeks | Posted | Mean | Standard Deviation | PSQI numeric score | 12 weeks |
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| Secondary | Physical Activity | Moderate to Vigorous Physical Activity and sedentary activity minutes per day assessed by 7 day accelerometer protocol | Only 11 participants had valid wear time data at both baseline and 12 weeks. | Posted | Mean | Standard Deviation | minutes/day | 12 weeks |
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| Secondary | Body Mass Index | Body Mass index (body weight in kilograms per height in meters squared) across 12 weeks | Posted | Mean | Standard Deviation | kg/m2 | 12 weeks |
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| Primary | Acceptability | Number of Participants who Found the Intervention Helpful. Semi-structured interviews were conducted with each caregiver to assess satisfaction with the intervention components. | Only 13 of the 20 participants were available for interviews at the end of the study. | Posted | Count of Participants | Participants | Between Weeks 12-14 |
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| 20 |
| 1 |
| 20 |
| 1 |
| 20 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Services Subscale Post-test mean and standard deviation |
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| Title |
|---|
| Measurements |
|---|
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| Sedentary activity Post-test mean and standard deviation |
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