NCT05938998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 12, 2025

Completed
Last Updated

September 12, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

June 29, 2023

Results QC Date

July 28, 2025

Last Update Submit

August 22, 2025

Conditions

Keywords

CaregiverDown syndromeIntellectual DisabilityParentStress

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (8)

  • Perceived Stress Scale Score

    12 weeks

  • ug/dL Salivary Cortisol

    12 weeks

  • The Multidimensional Scale of Perceived Social Support (MSPSS)

    12 weeks

  • Modified Caregiver Strain Index

    12 weeks

  • The Family Empowerment Scale

    12 weeks

  • +3 more secondary outcomes

Study Arms (1)

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.

Behavioral: Yoga; Support Group

Interventions

BEHAVIORAL: Group Exercise Sessions- Yoga. BEHAVIORAL: Social Support Sessions

Social Support and Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) caregiver of a young adult with IDD 2) self-reported ability to participate in a yoga class with no contraindications to participation.

You may not qualify if:

  • \) Actively participating in another health lifestyles interventional research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Caregiver BurdenDown SyndromeIntellectual Disability

Interventions

YogaSelf-Help Groups

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesOrganizationsHealth Care Economics and Organizations

Results Point of Contact

Title
Dr. Amy Bodde
Organization
University of Kansas Medical Center

Study Officials

  • Amy Bodde, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 11, 2023

Study Start

March 31, 2023

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

September 12, 2025

Results First Posted

September 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations