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

NCT ID: NCT07311252

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autism Spectrum Disorder Caregiver Burden Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Person-Centered Lifestyle Intervention

Intervention Type 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.

arm2-control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Ruya Gul Temel

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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OT-ASD-KMYTM-2025

Identifier Type: -

Identifier Source: org_study_id