Autism Spectrum DisorderNCT07757295
Effectiveness of an Online Psychological Support Program for Mothers of Children With Autism
A study testing Online Acceptance and Commitment Therapy-Based Parent Support Program in people with Autism Spectrum Disorder and Parenting, run by Sabri Hergüner at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study to evaluate the effectiveness of an online psychological support program for mothers of children diagnosed with Autism Spectrum Disorder (ASD). In this study, investigators aim to assess the impact of the psychological support program on mothers' mental health and parenting stress levels… Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder, Parenting, Well-Being
- What is being tested?
- Online Acceptance and Commitment Therapy-Based Parent Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participant must have at least one child with a clinically confirmed diagnosis of ASD.
- The child with autism must be between 2 and 11 years of age.
- Parents must be able to speak and read Turkish sufficiently.
- Parents must agree not to participate in any other mental health support program during the study.
Who cannot join
- Incomplete completion of the scales
- The child with autism is not between the ages of 2 and 11
- Parents are participating in another mental health support program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Online Psychological Support Program for Mothers of Children Diagnosed With Autism Spectrum Disorder: A Controlled Study
The aim of this study to evaluate the effectiveness of an online psychological support program for mothers of children diagnosed with Autism Spectrum Disorder (ASD). In this study, investigators aim to assess the impact of the psychological support program on mothers' mental health and parenting stress levels, investigate the factors associated with changes in parenting stress, and examine the effect of reduced parenting stress on children's behavioral problems and the severity of autism.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in social communication and interaction, repetitive behaviors, and restricted interests. Since ASD is a developmental disorder that affects language, speech, cognitive, social, and emotional skills, raising a child with ASD can be a challenging experience for parents. Parents of children with ASD generally experience higher levels of stress, anxiety, and depression compared to parents of typically developing children, and their chronic stress levels are also higher compared to parents of children with developmental delays. A longitudinal study has shown that acceptance plays a protective role in parents' adaptation to an autism diagnosis and is associated with lower levels of depression both cross-sectionally and over time. In contrast, caregivers with increasing levels of self-blame and hopelessness toward the diagnosis have been observed to experience worsened mental health and decreased life satisfaction.
Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioral therapy that focuses on acceptance and mindfulness. This therapeutic approach aims to increase psychological flexibility by altering individuals' relationship with events and their function through six flexible hexagonal concepts (acceptance, defusion, present moment contact, context-based self, values, and value-driven behavior). A review study conducted in 2022 demonstrated that ACT interventions for parents of children with ASD can be beneficial.
The rationale for this study stems from the need for approaches to improve the mental health of mothers of children diagnosed with ASD, as these mothers experience higher levels of stress, anxiety, and depression. The literature on the effects of ACT-based interventions on parents' psychological well-being is limited. Research on the effectiveness of ACT-based psychological support programs for parents of children with ASD is still in its early stages. Therefore, it is important to evaluate how ACT-based psychological support programs affect the anxiety, stress, and depression levels of parents of children with ASD, the factors related to these effects, and how reductions in parenting stress influence children's behavioral problems and autism severity.
- Conditions
- Autism Spectrum Disorder, Parenting, Well-Being, Psychological
- Being tested
- Online Acceptance and Commitment Therapy-Based Parent Support Program
- Keywords
- ASD, ACT, Parent, Well-Being
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Acceptance and Commitment Therapy-Based Parent Support ProgramBehavioural
The sessions are structured around the core ACT skills (contact with the present moment, acceptance, defusion, values, commitment, and contextual self). Each session includes stages of information sharing, exemplification, meditation practice, feedback, and group discussion. The topics and practices are derived from standardized content commonly used in ACT groups. After each session, home exercises related to the weekly topic are provided, and feedback on these exercises is gathered from participants at the beginning of the next session. Audio recordings for the meditation practices are created and sent to participants via email.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | Parents in the intervention group will participate in a 5-week Online Acceptance and Commitment Therapy (ACT) Based Parent Support Program. Six weeks after the program completion, they will attend a follow-up session for additional support. Receives: Behavioral: Online Acceptance and Commitment Therapy-Based Parent Support Program |
| The control group | No intervention | Participants assigned to the control group will not receive the intervention during the study period. They will remain on a waitlist and will receive the online ACT-based parent support program after completion of the post-intervention assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Depression, Anxiety, and Stress
The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-report questionnaire assessing symptoms of depression, anxiety, and stress. Each item is rated on a 4-point Likert scale (0-3). Scores for each subscale range from 0 to 42, with higher scores indicating greater symptom severity. The total score ranges from 0 to 126, with higher scores indicating greater overall psychological distress. The scale will be administered at baseline (T1), at the end of the 5-week intervention (T2), and at the 6-week follow-up (T3) in the intervention group. The control group will be assessed at T1 and T2 only. Changes in scores from T1 to T2 will be compared between groups using analysis of covariance (ANCOVA), controlling for baseline values. Within-group changes across T1, T2, and T3 will also be evaluated in the intervention group.
Measured: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
Secondary outcomes (6)
Changes in Parenting Stress
The 15-item version of the Parent Stress Scale (PSS) was used to assess parenting-related stress. Items are rated on a 5-point Likert scale. Total scores range from 15 to 75, with higher scores indicating greater parenting stress. The scale was administered at baseline (T1), at the end of the 5-week intervention (T2), and at 6-week follow-up (T3) in the intervention group. The control group was assessed at T1 and T2 only. Changes in scores from T1 to T2 will be compared between the intervention and control groups using analysis of covariance (ANCOVA), controlling for baseline values. Within-group changes across T1, T2, and T3 will be evaluated for the intervention group.
Measured: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
Changes in Autistic Traits (Autism Spectrum Quotient-10, AQ-10)
The Autism Spectrum Quotient-10 (AQ-10) was used to assess autistic traits. The scale consists of 10 items scored in a binary format (0-1). Total scores range from 0 to 10, with higher scores indicating greater levels of autistic traits. The scale was administered at T1, T2, and T3 in the intervention group, and at T1 and T2 in the control group. Changes in scores from T1 to T2 will be compared between groups using ANCOVA, controlling for baseline values. Within-group changes across T1, T2, and T3 will be evaluated for the intervention group.
Measured: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
Changes in Psychological Flexibility (Acceptance and Action Questionnaire-II, AAQ-II)
The Acceptance and Action Questionnaire-II (AAQ-II) was used to assess psychological flexibility. The scale consists of 7 items rated on a 7-point Likert scale. Total scores range from 7 to 49, with higher scores indicating greater psychological inflexibility (i.e., lower psychological flexibility). The scale was administered at T1, T2, and T3 in the intervention group, and at T1 and T2 in the control group. Changes in scores from T1 to T2 will be compared between groups using ANCOVA, controlling for baseline values. Within-group changes across T1, T2, and T3 will be evaluated for the intervention group.
Measured: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
Changes in Cognitive Fusion (Cognitive Fusion Questionnaire, CFQ)
The Cognitive Fusion Questionnaire (CFQ) was used to assess cognitive fusion. The scale consists of 7 items rated on a 7-point Likert scale. Total scores range from 7 to 49, with higher scores indicating greater cognitive fusion. The scale was administered at T1, T2, and T3 in the intervention group, and at T1 and T2 in the control group. Changes in scores from T1 to T2 will be compared between groups using ANCOVA, controlling for baseline values. Within-group changes across T1, T2, and T3 will be evaluated for the intervention group.
Measured: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
Changes in Autism Severity (Social Responsiveness Scale, SRS)
The Social Responsiveness Scale (SRS) was used to assess autism-related social impairments in children. The scale consists of 65 items rated on a Likert scale. Total scores range from 0 to 195, with higher scores indicating greater severity of autism symptoms. The scale was administered at baseline (T1) and at the end of the 5-week intervention (T2) in both groups. Changes in scores from T1 to T2 will be compared between the intervention and control groups using ANCOVA, controlling for baseline values.
Measured: Baseline (T1), End of Week 5 (T2)
Changes in Behavioral Problems (Abnormal Behavior Checklist, ABC)
The Abnormal Behavior Checklist (ABC) was used to evaluate behavioral problems in children. The scale consists of 58 items rated on a 4-point Likert scale. Total scores range from 0 to 174, with higher scores indicating greater severity of behavioral problems. The scale was administered at T1 and T2 in both groups. Changes in scores from T1 to T2 will be compared between the intervention and control groups using ANCOVA, controlling for baseline values.
Measured: Baseline (T1), End of Week 5 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start5 Jan 2025
- Primary completion28 Feb 2025
- Study completion30 Apr 2025
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parents of children with autism spectrum disorder (ASD) will be included in the study. The parents will be randomly assigned to either the intervention group or the control group. Participants from both groups will be asked to complete the forms one week before the intervention begins (T1). While the intervention group participates in the training, the control group will wait for the program to begin. After the intervention group completes the training, both groups will fill out the forms again (T2). Six weeks after the program ends, participants in the intervention group will be asked to complete the forms once more (T3).
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sabri Hergüner
- Sponsor type
- University, hospital or other
- Collaborators
- Herguner Therapy Private Clinic
- Responsible party
- Sponsor-investigator, Sabri Hergüner, Herguner Therapy Private Clinic
- Investigators
- Sabri Hergüner, Assoc.Prof., Study director, Herguner Tharapy Private Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757295
- Sponsor's protocol ID
- ACTParentsAutism
- Status last verified
- Aug 2026
- First submitted
- 25 Dec 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and confidentiality restrictions. The data include sensitive information from parents and children, and the informed consent obtained did not include permission for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Online Psychological Support Program for Mothers of Children Diagnosed With Autism Spectrum Disorder: A Controlled Study
- ClinicalTrials.gov ID
- NCT07757295
- Acronym / sponsor ID
- ACTParentsAutism
- Conditions
- Autism Spectrum Disorder, Parenting, Well-Being, Psychological
- Keywords
- ASD, ACT, Parent, Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Sabri HergünerUniversity, hospital or other
- Collaborators
- Herguner Therapy Private Clinic
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Aug 2026 (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.
The aim of this study to evaluate the effectiveness of an online psychological support program for mothers of children diagnosed with Autism Spectrum Disorder (ASD). In this study, investigators aim to assess the impact of the psychological support program on mothers' mental health and parenting stress levels, investigate the factors associated with changes in parenting stress, and examine the effect of reduced parenting stress on children's behavioral problems and the severity of autism.
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in social communication and interaction, repetitive behaviors, and restricted interests. Since ASD is a developmental disorder that affects language, speech, cognitive, social, and emotional skills, raising a child with ASD can be a challenging experience for parents. Parents of children with ASD generally experience higher levels of stress, anxiety, and depression compared to parents of typically developing children, and their chronic stress levels are also higher compared to parents of children with developmental delays. A longitudinal study has shown that acceptance plays a protective role in parents' adaptation to an autism diagnosis and is associated with lower levels of depression both cross-sectionally and over time. In contrast, caregivers with increasing levels of self-blame and hopelessness toward the diagnosis have been observed to experience worsened mental health and decreased life satisfaction.
Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioral therapy that focuses on acceptance and mindfulness. This therapeutic approach aims to increase psychological flexibility by altering individuals' relationship with events and their function through six flexible hexagonal concepts (acceptance, defusion, present moment contact, context-based self, values, and value-driven behavior). A review study conducted in 2022 demonstrated that ACT interventions for parents of children with ASD can be beneficial.
The rationale for this study stems from the need for approaches to improve the mental health of mothers of children diagnosed with ASD, as these mothers experience higher levels of stress, anxiety, and depression. The literature on the effects of ACT-based interventions on parents' psychological well-being is limited. Research on the effectiveness of ACT-based psychological support programs for parents of children with ASD is still in its early stages. Therefore, it is important to evaluate how ACT-based psychological support programs affect the anxiety, stress, and depression levels of parents of children with ASD, the factors related to these effects, and how reductions in parenting stress influence children's behavioral problems and autism severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parents of children with autism spectrum disorder (ASD) will be included in the study. The parents will be randomly assigned to either the intervention group or the control group. Participants from both groups will be asked to complete the forms one week before the intervention begins (T1). While the intervention group participates in the training, the control group will wait for the program to begin. After the intervention group completes the training, both groups will fill out the forms again (T2). Six weeks after the program ends, participants in the intervention group will be asked to complete the forms once more (T3).
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: Online Acceptance and Commitment Therapy-Based Parent Support ProgramParents in the intervention group will participate in a 5-week Online Acceptance and Commitment Therapy (ACT) Based Parent Support Program. Six weeks after the program completion, they will attend a follow-up session for additional support. |
| The control group | No intervention | –Participants assigned to the control group will not receive the intervention during the study period. They will remain on a waitlist and will receive the online ACT-based parent support program after completion of the post-intervention assessment. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The participant must have at least one child with a clinically confirmed diagnosis of ASD.
- The child with autism must be between 2 and 11 years of age.
- Parents must be able to speak and read Turkish sufficiently.
- Parents must agree not to participate in any other mental health support program during the study.
Key exclusion criteria (3 listed)
- Incomplete completion of the scales
- The child with autism is not between the ages of 2 and 11
- Parents are participating in another mental health support program.
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 |
|---|---|---|
| Online Acceptance and Commitment Therapy-Based Parent Support ProgramThe sessions are structured around the core ACT skills (contact with the present moment, acceptance, defusion, values, commitment, and contextual self). Each session includes stages of information sharing, exemplification, meditation practice, feedback, and group discussion. The topics and practices are derived from standardized content commonly used in ACT groups. After each session, home exercises related to the weekly topic are provided, and feedback on these exercises is gathered from participants at the beginning of the next session. Audio recordings for the meditation practices are created and sent to participants via email. | Behavioural | The intervention group |
Primary outcome
Changes in Depression, Anxiety, and Stress
Time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-report questionnaire assessing symptoms of depression, anxiety, and stress. Each item is rated on a 4-point Likert scale (0-3). Scores for each subscale range from 0 to 42, with higher scores indicating greater symptom severity. The total score ranges from 0 to 126, with higher scores indicating greater overall psychological distress. The scale will be administered at baseline (T1), at the end of the 5-week intervention (T2), and at the 6-week follow-up (T3) in the intervention group. The control group will be assessed at T1 and T2 only. Changes in scores from T1 to T2 will be compared between groups using analysis of covariance (ANCOVA), controlling for baseline values. Within-group changes across T1, T2, and T3 will also be evaluated in the intervention group.
6 secondary outcomes
Changes in Parenting Stress
Time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
Changes in Autistic Traits (Autism Spectrum Quotient-10, AQ-10)
Time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
Changes in Psychological Flexibility (Acceptance and Action Questionnaire-II, AAQ-II)
Time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
Changes in Cognitive Fusion (Cognitive Fusion Questionnaire, CFQ)
Time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
Changes in Autism Severity (Social Responsiveness Scale, SRS)
Time frame: Baseline (T1), End of Week 5 (T2)
Changes in Behavioral Problems (Abnormal Behavior Checklist, ABC)
Time frame: Baseline (T1), End of Week 5 (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and confidentiality restrictions. The data include sensitive information from parents and children, and the informed consent obtained did not include permission for data sharing.
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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. This study is not recruiting at the moment.
Sabri Hergüner, Assoc.Prof. study director
Herguner Tharapy Private Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Acceptance and Commitment Therapy-Based Parent Support Program in people with Autism Spectrum Disorder and Parenting, run by Sabri Hergüner at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Depression, Anxiety, and Stress (time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)). 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 11 Aug 2026.