Psychological ResilienceNCT07738289
Does Group Therapy Improve Resilience and Family Functioning Among Mothers of Children With Intellectual Disabilities?
A study testing Structured Group Therapy in people with Psychological Resilience and Family Functioning, run by Sinop University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Resilience, Family Functioning
- What is being tested?
- Structured Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2023to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Psychological Resilience, Family Functioning
- Being tested
- Structured Group Therapy
- Keywords
- Intellectual Disability, Psychological resilience, Family Functioning, Group Therapy, Mixed-Methods
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Group TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 7, and Week 19
Secondary outcomes (1)
Family Assessment Device (FAD)
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.
Measured: Baseline, Week 7, and Week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start18 Dec 2023
- Primary completion8 Feb 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological ResilienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz ER, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738289
- Sponsor's protocol ID
- 2023/243
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality and the absence of consent for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Group Therapy Intervention in Enhancing Resilience and Family Functioning Among Mothers of Children With Intellectual Disabilities: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07738289
- Acronym / sponsor ID
- 2023/243
- Conditions
- Psychological Resilience, Family Functioning
- Keywords
- Intellectual Disability, Psychological resilience, Family Functioning, Group Therapy, Mixed-Methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group Therapy Intervention | Experimental | Behavioral: Structured Group TherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Group TherapyIntervention 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 | Behavioural | Group Therapy Intervention |
Primary outcome
Resilience Scale for Adults (RSA)
Time frame: Baseline, Week 7, and Week 19
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.
1 secondary outcome
Family Assessment Device (FAD)
Time frame: Baseline, Week 7, and Week 19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant confidentiality and the absence of consent for public data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Group Therapy in people with Psychological Resilience and Family Functioning, run by Sinop University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience Scale for Adults (RSA) (time frame: Baseline, Week 7, and Week 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.