Effectiveness of a Person-Centered Lifestyle Intervention in Mothers of Children With Autism Spectrum Disorder

NCT07311252 | Not Yet Recruiting

• 1 other identifier: OT-ASD-KMYTM-2025
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mothers of children with autism spectrum disorder (ASD) experience substantial physical, emotional, and social strain due to the demands of continuous caregiving. These responsibilities often limit opportunities for health-promoting behaviors and contribute to elevated stress, fatigue, sleep disturbances, and reduced wellbeing. This study aims to evaluate an intervention designed to support the health and wellbeing of mothers who serve as primary caregivers of children with ASD. The intervention focuses on enhancing stress-management skills, improving participation in meaningful daily activities, and promoting balanced health behaviors through structured psychoeducational and occupation-based strategies. The goal of the trial is to determine whether a holistic, individualized, and occupation-centered approach delivered by occupational therapists can improve maternal wellbeing and support sustainable engagement in health-promoting routines.

Conditions

Autism Spectrum Disorder; Caregiver Burden; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Occupational Performance and Satisfaction Occupational Performance and Satisfaction

  Occupational performance and satisfaction will be assessed using the Canadian Occupational Performance Measure. Participants identify meaningful daily activities and rate their performance and satisfaction with performance on a 10-point scale. Higher scores indicate better occupational performance and greater satisfaction.

  Baseline, immediately post-intervention (1 month), and 6 months follow-up

Secondary Outcomes (3)

• Caregiver Burden

  Baseline, immediately post-intervention (1 month), and 6 months follow-up

• Psychological Status

  Baseline, immediately post-intervention (1 month), and 6 months follow-up

• Health-Related Quality of Life

  Baseline, immediately post-intervention (1 month), and 6 months follow-up

Study Arms (2)

arm1

EXPERIMENTAL

Person-Centered Lifestyle Intervention; Participants will receive a person-centered lifestyle intervention consisting of eight sessions delivered twice weekly over a one-month period.

Behavioral: Person-Centered Lifestyle Intervention

arm2-control

NO INTERVENTION

Participants will continue their usual daily routines and will not receive the lifestyle intervention during the study period.

Interventions

Person-Centered Lifestyle Intervention BEHAVIORAL

A structured person-centered lifestyle intervention delivered by occupational therapists, consisting of eight sessions over four weeks, focusing on individualized goal setting, occupational balance, stress management, and health-promoting routines.

arm1

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mother of a child with a medically confirmed diagnosis of autism spectrum disorder
• Primary caregiver and living with the child
• Age 18 years or older
• Ability to participate in all intervention sessions and assessments

You may not qualify if:

• Pregnancy or postpartum period
• Having more than one child with a disability
• Participation in a similar lifestyle or caregiver intervention program within the past year
• Presence of a diagnosed severe physical, mental, or psychiatric condition that would interfere with participation

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Autism Spectrum Disorder; Caregiver Burden

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12