Hergüner Therapy Private Clinic
Ankara, Turkey (Türkiye)
NCT Number: NCT07757295
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.
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Notify Me2 year–11 year
All sexes
Interventional
Not applicable
Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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.
Time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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.
Time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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.
Time frame: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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.
Time frame: Baseline (T1), End of Week 5 (T2)
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.
Time frame: Baseline (T1), End of Week 5 (T2)
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.
Sabri Hergüner
Other
Effectiveness of an Online Psychological Support Program for Mothers of Children Diagnosed With Autism Spectrum Disorder: A Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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