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

December 16, 2025 updated by: Ruya Gul Temel, Hacettepe University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occupational Performance and Satisfaction Occupational Performance and Satisfaction
Time Frame: Baseline, immediately post-intervention (1 month), and 6 months follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregiver Burden
Time Frame: Baseline, immediately post-intervention (1 month), and 6 months follow-up
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
Time Frame: Baseline, immediately post-intervention (1 month), and 6 months follow-up
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
Time Frame: Baseline, immediately post-intervention (1 month), and 6 months follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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