NCT07757295

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

December 25, 2024

Last Update Submit

August 7, 2026

Conditions

Keywords

ASD, ACT, Parent, Well-Being

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)

Secondary Outcomes (6)

  • Changes in Parenting Stress

    Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)

  • Changes in Autistic Traits (Autism Spectrum Quotient-10, AQ-10)

    Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)

  • Changes in Psychological Flexibility (Acceptance and Action Questionnaire-II, AAQ-II)

    Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)

  • Changes in Cognitive Fusion (Cognitive Fusion Questionnaire, CFQ)

    Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)

  • Changes in Autism Severity (Social Responsiveness Scale, SRS)

    Baseline (T1), End of Week 5 (T2)

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

The intervention group

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hergüner Therapy Private Clinic

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sabri Hergüner, Assoc.Prof.

    Herguner Tharapy Private Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor Dr Sabri Hergüner

Study Record Dates

First Submitted

December 25, 2024

First Posted

August 11, 2026

Study Start

January 5, 2025

Primary Completion

February 28, 2025

Study Completion

April 30, 2025

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations