Autism Spectrum DisorderNCT07311252
Effectiveness of a Person-Centered Lifestyle Intervention in Mothers of Children With Autism Spectrum Disorder
A study testing Person-Centered Lifestyle Intervention in people with Autism Spectrum Disorder and Caregiver Burden, run by Hacettepe University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Autism Spectrum Disorder, Caregiver Burden, Quality of Life
- What is being tested?
- Person-Centered Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Caregiver Burden, Quality of Life
- Being tested
- Person-Centered Lifestyle Intervention
- Medical subject headings
- Autism Spectrum Disorder, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-Centered Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately post-intervention (1 month), and 6 months follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately post-intervention (1 month), and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruya Gul Temel, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311252
- Sponsor's protocol ID
- OT-ASD-KMYTM-2025
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Person-Centered Lifestyle Intervention in Mothers of Children With Autism Spectrum Disorder: A Randomized Controlled Trial With 6-Month Follow-Up
- ClinicalTrials.gov ID
- NCT07311252
- Acronym / sponsor ID
- OT-ASD-KMYTM-2025
- Conditions
- Autism Spectrum Disorder, Caregiver Burden, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm1 | Experimental | Behavioral: Person-Centered Lifestyle InterventionPerson-Centered Lifestyle Intervention; Participants will receive a person-centered lifestyle intervention consisting of eight sessions delivered twice weekly over a one-month period. |
| arm2-control | No intervention | –Participants will continue their usual daily routines and will not receive the lifestyle intervention during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-Centered Lifestyle InterventionA 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. | Behavioural | arm1 |
Primary outcome
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.
3 secondary outcomes
Caregiver Burden
Time frame: 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
Health-Related Quality of Life
Time frame: Baseline, immediately post-intervention (1 month), and 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Person-Centered Lifestyle Intervention in people with Autism Spectrum Disorder and Caregiver Burden, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational Performance and Satisfaction Occupational Performance and Satisfaction (time frame: Baseline, immediately post-intervention (1 month), and 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.