- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07757295
Effectiveness of an Online Psychological Support Program for Mothers of Children With Autism
Effectiveness of an Online Psychological Support Program for Mothers of Children Diagnosed With Autism Spectrum Disorder: A Controlled Study
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Ankara, Törökország (Türkiye)
- Herguner Therapy Private Clinic
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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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Nincs beavatkozás: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Changes in Depression, Anxiety, and Stress
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Changes in Parenting Stress
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Tanulmányi igazgató: Sabri Hergüner, Assoc.Prof., Herguner Tharapy Private Clinic
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- ACTParentsAutism
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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