- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07738289
Does Group Therapy Improve Resilience and Family Functioning Among Mothers of Children With Intellectual Disabilities?
Effectiveness of a Group Therapy Intervention in Enhancing Resilience and Family Functioning Among Mothers of Children With Intellectual Disabilities: A Mixed-Methods Study
Abstract This study examined the effectiveness of a seven-week structured group therapy intervention designed to enhance the psychological resilience and family functioning of mothers of children with intellectual disabilities. A randomized controlled mixed-methods design was employed, involving an intervention group (n = 10) and a control group (n = 10). Participants were randomly assigned to study groups through a simple randomization procedure conducted by an independent academic who was not involved in participant recruitment, intervention delivery, or outcome assessment.
The intervention consisted of seven weekly face-to-face group sessions, each lasting approximately 90-120 minutes, and was delivered by a licensed social worker using a structured manualized protocol. The program integrated psychoeducation, cognitive-behavioral techniques, mindfulness-informed practices, self-compassion exercises, relaxation techniques, strengths-based approaches, and therapeutic group processes. Quantitative outcomes were assessed using the Resilience Scale for Adults (RSA) and the Family Assessment Device (FAD) at baseline, immediately after the intervention, and at a three-month follow-up. The quantitative component employed a two-way mixed-design repeated measures ANOVA to evaluate changes across assessment points. The qualitative component involved the collection of participants' verbal narratives and group interactions throughout the intervention, which were analyzed using reflexive thematic analysis and group process analysis to explore participants' experiences and therapeutic processes.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Detailed Description
Mothers of children with intellectual disabilities often experience substantial psychological, emotional, and social challenges associated with long-term caregiving responsibilities. These challenges may adversely affect psychological resilience, family functioning, and overall well-being. Although psychosocial interventions have demonstrated promising effects, evidence regarding structured group therapy programs specifically developed for this population remains limited.
The present study aimed to evaluate the effectiveness of a structured seven-session group therapy intervention in enhancing psychological resilience and family functioning among mothers of children with intellectual disabilities using a randomized controlled mixed-methods design. Eligible participants were randomly assigned to either an intervention group or a control group through a simple randomization procedure conducted by an independent academic who was not involved in participant recruitment, intervention delivery, or outcome assessment.
The intervention consisted of seven weekly face-to-face group sessions delivered by a licensed social worker. Each session lasted approximately 90-120 minutes and followed a structured manualized protocol integrating psychoeducation, cognitive-behavioral techniques, mindfulness-informed practices, self-compassion exercises, relaxation techniques, strengths-based approaches, and therapeutic group processes. Session topics included building trust and group cohesion, emotional awareness and expression, acceptance and stress management, cognitive reframing and family adaptation, self-compassion, awareness of personal needs and social support, and integration of therapeutic gains into daily life.
Participants allocated to the control group received no intervention during the study period. Quantitative outcomes were assessed using the Resilience Scale for Adults (RSA) and the Family Assessment Device (FAD) at baseline, immediately after the intervention, and three months after completion of the intervention.
To complement the quantitative component, qualitative data were collected throughout the intervention from participants' verbal narratives and group interactions. These data were analyzed using reflexive thematic analysis and group process analysis to explore participants' experiences, perceived changes, and therapeutic processes.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Merkez
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Sinop, Merkez, Turecko (Türkiye), 57100
- Sinop University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria
- Female adults aged 18 years or older.
- Mothers who were the primary caregivers of a child diagnosed with intellectual disability according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- Had provided continuous care for the child with intellectual disability for at least five years.
- Able to communicate in Turkish and participate in group sessions.
- Voluntarily agreed to participate in the study and provided written informed consent.
Exclusion Criteria
- Presence of a chronic physical or mental illness severe enough to interfere with participation in the group intervention or group interaction.
- Inability or unwillingness to participate throughout the intervention.
- Withdrawal of informed consent at any stage of the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Group Therapy Intervention
Participants received a structured seven-session face-to-face group therapy intervention delivered once weekly by a licensed social worker.
Each session lasted approximately 90-120 minutes and incorporated psychoeducation, cognitive-behavioral techniques, mindfulness-informed practices, self-compassion exercises, relaxation techniques, strengths-based approaches, and therapeutic group processes.
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Intervention Description Participants assigned to the intervention group received an eight-session manualized group therapy program, delivered once weekly in face-to-face group sessions by a licensed social worker. Each session lasted approximately 90-120 minutes and followed a structured protocol designed to enhance resilience and family functioning among mothers of children with intellectual disabilities. The intervention integrated psychoeducation, cognitive-behavioral techniques, mindfulness-based practices, relaxation exercises, self-compassion training, strengths-based approaches, and group process interventions. The sessions addressed (1) group cohesion and psychological safety, (2) emotional awareness and expression, (3) acceptance and stress management, (4) cognitive reframing and family adaptation, (5) self-compassion and realistic expectations, (6) social support and awareness of personal needs, (7) integration of therapeutic gains into daily life, and program review, evalua |
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Žádný zásah: Control Group
Participants assigned to the control group received no intervention during the study period and completed the same outcome assessments as the intervention group at baseline, post-intervention, and three-month follow-up.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Resilience Scale for Adults (RSA)
Časové okno: Baseline, Week 7, and Week 19
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Psychological resilience was assessed using the Resilience Scale for Adults (RSA), a 33-item self-report instrument that evaluates six domains of resilience: perception of self, perception of future, structured style, social competence, family cohesion, and social resources.
Higher total scores indicate greater psychological resilience.
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Baseline, Week 7, and Week 19
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Family Assessment Device (FAD)
Časové okno: Baseline, Week 7, and Week 19
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Family functioning was assessed using the Family Assessment Device (FAD), a 60-item self-report instrument based on the McMaster Model of Family Functioning.
The scale evaluates problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general functioning.
Lower scores indicate healthier family functioning, whereas higher scores indicate greater family dysfunction.
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Baseline, Week 7, and Week 19
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2023/243
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Popis plánu IPD
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