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

Effectiveness of a Person-Centered Lifestyle Intervention in Mothers of Children With Autism Spectrum Disorder: A Randomized Controlled Trial With 6-Month Follow-Up

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Caregiver Burden; Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Person-Centered Lifestyle Intervention

Detailed Description

Caregivers provide extensive support to individuals with special needs across the lifespan by assisting with daily living activities and health-related needs. In many societies, caregiving is primarily assumed as a family responsibility, and women, particularly mothers, most often undertake the primary caregiving role for children with special needs. Mothers of children with autism spectrum disorder frequently devote substantial time and energy to caregiving tasks and to facilitating their children's participation in daily life, which may limit opportunities for self-care, health-promoting activities, rest, and access to healthcare services.

Autism spectrum disorder is a highly heterogeneous condition that requires long-term and multifaceted support across educational, health, and social domains. The continuous caregiving demands associated with autism spectrum disorder place mothers at increased risk for physical strain, psychological distress, reduced quality of life, and disruptions in daily routines. Caregiving is a subjective experience, and the needs and expectations of caregivers of children differ from those caring for adults, highlighting the importance of individualized and context-sensitive interventions.

Most existing interventions for caregivers focus primarily on improving parenting skills or child outcomes, while fewer programs directly target caregiver health and wellbeing. Evidence suggests that interventions incorporating cognitive, behavioral, and educational components may support stress management, problem-solving skills, and healthy lifestyle behaviors. However, no single intervention approach adequately addresses the complex and individualized needs of caregiving mothers.

This study is designed as a randomized controlled trial with a six-month follow-up period to examine the effectiveness of a person-centered lifestyle intervention for mothers who are primary caregivers of children diagnosed with autism spectrum disorder. Participants will be randomly assigned to an intervention group or a control group using a computer-assisted randomization process. The intervention consists of eight sessions delivered twice weekly over one month and focuses on individualized goal setting, occupational balance, health-promoting routines, stress management strategies, and meaningful participation in daily activities. The control group will continue their usual daily routines without receiving the intervention during the study period.

Outcomes related to occupational performance and satisfaction, caregiver burden, psychological status, and health-related quality of life will be assessed at baseline, immediately following the intervention, and at six months to evaluate short-term and sustained effects of the intervention. The study adopts a holistic, biopsychosocial, and person-centered approach consistent with occupational therapy practice, with the aim of informing future caregiver-focused interventions in pediatric rehabilitation.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arm1; 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; 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.
No Intervention: arm2-control; Participants will continue their usual daily routines and will not receive the lifestyle intervention during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Burden	Caregiver burden will be evaluated using the Zarit Caregiver Burden Interview, which assesses the perceived impact of caregiving responsibilities on emotional, social, and physical wellbeing. Higher scores indicate greater caregiver burden.	Baseline, immediately post-intervention (1 month), and 6 months follow-up
Psychological Status	Psychological status will be assessed using the Depression Anxiety Stress Scale, which measures symptoms related to depression, anxiety, and stress. Higher scores reflect greater psychological distress.	Baseline, immediately post-intervention (1 month), and 6 months follow-up
Health-Related Quality of Life	Health-related quality of life will be assessed using the Nottingham Health Profile, which evaluates perceived health problems across physical, emotional, and social domains. Higher scores indicate poorer perceived health status.	Baseline, immediately post-intervention (1 month), and 6 months follow-up

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Stress, Psychological; Behavior; Autism Spectrum Disorder; Caregiver Burden
• Other Study ID Numbers: OT-ASD-KMYTM-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No