Burden, Caregiver
Conditions
Keywords
Caregiver, Down syndrome, Intellectual Disability, Parent, Stress
Brief 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.
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.
Interventions
BEHAVIORALYoga; Support Group
BEHAVIORAL: Group Exercise Sessions- Yoga. BEHAVIORAL: Social Support Sessions
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 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 | 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 | From baseline to 12 weeks | Mean number of sessions attended out of 12 possible sessions |
| Retention | Weeks 1-12 of intervention | Calculated as percentage of participants who completed the out of those who enrolled |
| Acceptability | 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
| Measure | Time frame | Description |
|---|---|---|
| The Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Perceived Stress Scale Score | 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. |
| Body Mass Index | 12 weeks | Body Mass index (body weight in kilograms per height in meters squared) across 12 weeks |
| Physical Activity | 12 weeks | Moderate to Vigorous Physical Activity and sedentary activity minutes per day assessed by 7 day accelerometer protocol |
| ug/dL Salivary Cortisol | 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. |
| The Multidimensional Scale of Perceived Social Support (MSPSS) | 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. |
| Modified Caregiver Strain Index | 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. |
| The Family Empowerment Scale | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
This was a single-arm pilot trial, therefore all participants were assigned to the intervention arm.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 This is a single arm trial, therefore Arm 1 is the intervention arm. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Arm 1 |
|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Family caregiver | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
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.
Time frame: Between Weeks 12-14
Population: Only 13 of the 20 participants were available for interviews at the end of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Acceptability | 13 Participants |
Primary
Mean Number of Sessions Attended
Mean number of sessions attended out of 12 possible sessions
Time frame: From baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Mean Number of Sessions Attended | 8 Sessions attended | Standard Deviation 3.5 |
Primary
Recruitment
We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire.
Time frame: Baseline
Population: 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%.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Recruitment | 20 Participants |
Primary
Retention
Calculated as percentage of participants who completed the out of those who enrolled
Time frame: Weeks 1-12 of intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Retention | 19 Participants |
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.
Time frame: Weeks 1-12 of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Session Attendance | 8 sessions attended | Standard Deviation 3 |
Secondary
Body Mass Index
Body Mass index (body weight in kilograms per height in meters squared) across 12 weeks
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Body Mass Index | Pre-test mean and standard deviation | 28.9 kg/m2 | Standard Deviation 7.4 |
| Arm 1 | Body Mass Index | Post-test mean and standard deviation | 28.7 kg/m2 | Standard Deviation 7.4 |
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.
Time frame: 12 weeks
Population: 16 participants completed this survey at both baseline and 12 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Modified Caregiver Strain Index | Pre-test mean and standard deviation | 9.2 Numeric score on MCSI measure | Standard Deviation 5.2 |
| Arm 1 | Modified Caregiver Strain Index | Post-test mean and standard deviation | 9.3 Numeric score on MCSI measure | Standard Deviation 4.1 |
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.
Time frame: 12 weeks
Population: 16 participants were available for outcomes assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Perceived Stress Scale Score | Pre-test mean and standard deviation | 22.6 Perceived Stress Scale Numeric Score | Standard Deviation 3.9 |
| Arm 1 | Perceived Stress Scale Score | Post-test mean and standard deviation | 21.3 Perceived Stress Scale Numeric Score | Standard Deviation 4.1 |
Secondary
Physical Activity
Moderate to Vigorous Physical Activity and sedentary activity minutes per day assessed by 7 day accelerometer protocol
Time frame: 12 weeks
Population: Only 11 participants had valid wear time data at both baseline and 12 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Physical Activity | Moderate to Vigorous physical activity Pre-test mean and standard deviation | 31.1 minutes/day | Standard Deviation 17 |
| Arm 1 | Physical Activity | Moderate to Vigorous physical activity Post-test mean and standard deviation | 32.6 minutes/day | Standard Deviation 21.9 |
| Arm 1 | Physical Activity | Sedentary activity Pre-test mean and standard deviation | 494.1 minutes/day | Standard Deviation 95.6 |
| Arm 1 | Physical Activity | Sedentary activity Post-test mean and standard deviation | 487.2 minutes/day | Standard Deviation 121.6 |
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.
Time frame: 12 weeks
Population: 16 participants were available for this outcome assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | The Family Empowerment Scale | Family Subscale Pre-test mean and standard deviation | 3.8 Subscales numeric scores | Standard Deviation 0.6 |
| Arm 1 | The Family Empowerment Scale | Family Subscale Post-test mean and standard deviation | 4.0 Subscales numeric scores | Standard Deviation 4.9 |
| Arm 1 | The Family Empowerment Scale | Services Subscale Pre-test mean and standard deviation | 4.0 Subscales numeric scores | Standard Deviation 0.6 |
| Arm 1 | The Family Empowerment Scale | Services Subscale Post-test mean and standard deviation | 4.0 Subscales numeric scores | Standard Deviation 0.6 |
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.
Time frame: 12 weeks
Population: 15 participants returned surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | The Multidimensional Scale of Perceived Social Support (MSPSS) | Pre-test mean and standard deviation | 5.1 MSPSS numeric score | Standard Deviation 1.4 |
| Arm 1 | The Multidimensional Scale of Perceived Social Support (MSPSS) | Post-test mean and standard deviation | 5.6 MSPSS numeric score | Standard Deviation 0.8 |
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.
Time frame: 12 weeks
Population: 14 participants had valid sleep data at baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | The Pittsburgh Sleep Quality Index (PSQI) | Pre-test mean and standard deviation | 7.5 PSQI numeric score | Standard Deviation 2.9 |
| Arm 1 | The Pittsburgh Sleep Quality Index (PSQI) | Post-test mean and standard deviation | 7.6 PSQI numeric score | Standard Deviation 4 |
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.
Time frame: 12 weeks
Population: 13 participants completed saliva samples at both baseline and 12 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | ug/dL Salivary Cortisol | Pre-test mean and standard deviation | 0.63 ug/dL | Standard Deviation 0.5 |
| Arm 1 | ug/dL Salivary Cortisol | Post-test mean and standard deviation | 0.48 ug/dL | Standard Deviation 0.2 |