Effectiveness of an Online Psychological Support Program for Mothers of Children With Autism
7. srpna 2026 aktualizováno: Sabri Hergüner
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.
Přehled studie
Postavení
Dokončeno
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
181
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ankara, Turecko (Türkiye)
- Herguner Therapy Private Clinic
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: The intervention group
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.
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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.
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Žádný zásah: The control group
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Changes in Depression, Anxiety, and Stress
Časové okno: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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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.
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Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Changes in Parenting Stress
Časové okno: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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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.
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Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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Changes in Autistic Traits (Autism Spectrum Quotient-10, AQ-10)
Časové okno: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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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.
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Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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Changes in Psychological Flexibility (Acceptance and Action Questionnaire-II, AAQ-II)
Časové okno: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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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.
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Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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Changes in Cognitive Fusion (Cognitive Fusion Questionnaire, CFQ)
Časové okno: Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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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.
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Baseline (T1), End of Week 5 (T2), End of Week 11 (T3)
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Changes in Autism Severity (Social Responsiveness Scale, SRS)
Časové okno: Baseline (T1), End of Week 5 (T2)
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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.
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Baseline (T1), End of Week 5 (T2)
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Changes in Behavioral Problems (Abnormal Behavior Checklist, ABC)
Časové okno: Baseline (T1), End of Week 5 (T2)
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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.
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Baseline (T1), End of Week 5 (T2)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Sabri Hergüner, Assoc.Prof., Herguner Tharapy Private Clinic
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
5. ledna 2025
Primární dokončení (Aktuální)
28. února 2025
Dokončení studie (Aktuální)
30. dubna 2025
Termíny zápisu do studia
První předloženo
25. prosince 2024
První předloženo, které splnilo kritéria kontroly kvality
7. srpna 2026
První zveřejněno (Aktuální)
11. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ACTParentsAutism
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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