Trial Outcomes & Findings for Social Support and Stress Reduction for Caregivers of Young Adults With IDD (NCT NCT05938998)

NCT ID: NCT05938998

Last Updated: 2025-09-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-09-12

Participant Flow

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.

This was a single-arm pilot trial, therefore all participants were assigned to the intervention arm.

Participant milestones

Measure	Arm 1 This is a single arm trial, therefore Arm 1 is the intervention arm.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm 1 n=20 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Age, Continuous	51.6 years STANDARD_DEVIATION 11.7 • n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	20 Participants n=93 Participants
Family caregiver	19 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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%.

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

Outcome measures

Measure	Arm 1 n=25 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Recruitment	20 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm 1 n=19 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Session Attendance	8 sessions attended Standard Deviation 3

PRIMARY outcome

Timeframe: From baseline to 12 weeks

Mean number of sessions attended out of 12 possible sessions

Outcome measures

Measure	Arm 1 n=19 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Mean Number of Sessions Attended	8 Sessions attended Standard Deviation 3.5

PRIMARY outcome

Timeframe: Weeks 1-12 of intervention

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

Outcome measures

Measure	Arm 1 n=20 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Retention	19 Participants

PRIMARY outcome

Timeframe: Between Weeks 12-14

Population: Only 13 of the 20 participants were available for interviews at the end of the study.

Number of Participants who Found the Intervention Helpful. Semi-structured interviews were conducted with each caregiver to assess satisfaction with the intervention components.

Outcome measures

Measure	Arm 1 n=13 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Acceptability	13 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: 16 participants were available for outcomes assessment

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.

Outcome measures

Measure	Arm 1 n=16 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Perceived Stress Scale Score Pre-test mean and standard deviation	22.6 Perceived Stress Scale Numeric Score Standard Deviation 3.9
Perceived Stress Scale Score Post-test mean and standard deviation	21.3 Perceived Stress Scale Numeric Score Standard Deviation 4.1

SECONDARY outcome

Timeframe: 12 weeks

Population: 13 participants completed saliva samples at both baseline and 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.

Outcome measures

Measure	Arm 1 n=13 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
ug/dL Salivary Cortisol Pre-test mean and standard deviation	0.63 ug/dL Standard Deviation 0.5
ug/dL Salivary Cortisol Post-test mean and standard deviation	0.48 ug/dL Standard Deviation 0.2

SECONDARY outcome

Timeframe: 12 weeks

Population: 15 participants returned surveys.

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.

Outcome measures

Measure	Arm 1 n=15 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
The Multidimensional Scale of Perceived Social Support (MSPSS) Pre-test mean and standard deviation	5.1 MSPSS numeric score Standard Deviation 1.4
The Multidimensional Scale of Perceived Social Support (MSPSS) Post-test mean and standard deviation	5.6 MSPSS numeric score Standard Deviation 0.8

SECONDARY outcome

Timeframe: 12 weeks

Population: 16 participants completed this survey at both baseline and 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.

Outcome measures

Measure	Arm 1 n=16 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Modified Caregiver Strain Index Pre-test mean and standard deviation	9.2 Numeric score on MCSI measure Standard Deviation 5.2
Modified Caregiver Strain Index Post-test mean and standard deviation	9.3 Numeric score on MCSI measure Standard Deviation 4.1

SECONDARY outcome

Timeframe: 12 weeks

Population: 16 participants were available for this outcome assessment

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.

Outcome measures

Measure	Arm 1 n=16 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
The Family Empowerment Scale Family Subscale Pre-test mean and standard deviation	3.8 Subscales numeric scores Standard Deviation 0.6
The Family Empowerment Scale Family Subscale Post-test mean and standard deviation	4.0 Subscales numeric scores Standard Deviation 4.9
The Family Empowerment Scale Services Subscale Pre-test mean and standard deviation	4.0 Subscales numeric scores Standard Deviation 0.6
The Family Empowerment Scale Services Subscale Post-test mean and standard deviation	4.0 Subscales numeric scores Standard Deviation 0.6

SECONDARY outcome

Timeframe: 12 weeks

Population: 14 participants had valid sleep data at baseline and 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.

Outcome measures

Measure	Arm 1 n=14 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
The Pittsburgh Sleep Quality Index (PSQI) Pre-test mean and standard deviation	7.5 PSQI numeric score Standard Deviation 2.9
The Pittsburgh Sleep Quality Index (PSQI) Post-test mean and standard deviation	7.6 PSQI numeric score Standard Deviation 4.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Only 11 participants had valid wear time data at both baseline and 12 weeks.

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

Outcome measures

Measure	Arm 1 n=11 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Physical Activity Moderate to Vigorous physical activity Pre-test mean and standard deviation	31.1 minutes/day Standard Deviation 17
Physical Activity Moderate to Vigorous physical activity Post-test mean and standard deviation	32.6 minutes/day Standard Deviation 21.9
Physical Activity Sedentary activity Pre-test mean and standard deviation	494.1 minutes/day Standard Deviation 95.6
Physical Activity Sedentary activity Post-test mean and standard deviation	487.2 minutes/day Standard Deviation 121.6

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Arm 1 n=16 Participants This is a single arm trial, therefore Arm 1 is the intervention arm.
Body Mass Index Pre-test mean and standard deviation	28.9 kg/m2 Standard Deviation 7.4
Body Mass Index Post-test mean and standard deviation	28.7 kg/m2 Standard Deviation 7.4

Adverse Events

Arm 1

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1 n=20 participants at risk This is a single arm trial, therefore Arm 1 is the intervention arm.
Respiratory, thoracic and mediastinal disorders Pneumonia hospitalization	5.0% 1/20 • Number of events 1 • From enrollment in the study to the end of measures completion, approximately 14 weeks

Other adverse events

Measure	Arm 1 n=20 participants at risk This is a single arm trial, therefore Arm 1 is the intervention arm.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 1 • From enrollment in the study to the end of measures completion, approximately 14 weeks

Additional Information

Dr. Amy Bodde

University of Kansas Medical Center

Phone: 913-588-7983

Email: abodde@kumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place