NCT07738289

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

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

Study Start

First participant enrolled

December 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 27, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

Intellectual DisabilityPsychological resilienceFamily FunctioningGroup TherapyMixed-Methods

Outcome Measures

Primary Outcomes (1)

  • Resilience Scale for Adults (RSA)

    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.

    Baseline, Week 7, and Week 19

Secondary Outcomes (1)

  • Family Assessment Device (FAD)

    Baseline, Week 7, and Week 19

Study Arms (2)

Group Therapy Intervention

EXPERIMENTAL

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.

Behavioral: Structured Group Therapy

Control Group

NO INTERVENTION

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.

Interventions

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

Group Therapy Intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly mothers of children with intellectual disabilities were eligible for participation because the structured group therapy intervention was specifically developed to enhance their psychological resilience and family functioning.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop University

Sinop, Merkez, 57100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly allocated to either an intervention group or a control group using a simple randomization procedure conducted by an independent academic. The intervention group participated in a structured seven-session face-to-face group therapy program delivered once weekly, whereas the control group received no intervention during the study period. Both groups completed the same outcome assessments at baseline, post-intervention, and three-month follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 31, 2026

Study Start

December 18, 2023

Primary Completion

February 8, 2024

Study Completion

May 20, 2024

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to participant confidentiality and the absence of consent for public data sharing.

Locations