Family ResilienceNCT07816653
MIND-FULNESS-BASED FAMILY RESILIENCE INTERVENTION FOR MOTHERS OF CHILDREN WITH INTELLECTUAL DISABILITIES
A study testing Mindfulness-Based Family Resilience Group Intervention in people with Family Resilience and Mindfulness, run by Sinop University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether an eight-week Mindfulness-Based Family Resilience Group Intervention can improve family resilience and mindfulness in mothers of children with intellectual disabilities. Read more about this study
- Who is it for?
- Ages 27 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Family Resilience, Mindfulness
- What is being tested?
- Mindfulness-Based Family Resilience Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2026to 21 Jul 2026
- 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 27 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- * Mothers of children aged 9-17 years.
- Mothers whose children had mild or moderate intellectual disability.
- Willingness to participate in the study and provide informed consent.
Who cannot join
- Mothers whose children had severe intellectual disability.
- Not meeting the predefined inclusion criteria.
- Declining to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STRENGTHENING FAMILY RESILIENCE THROUGH MINDFULNESS: A RANDOMIZED CONTROLLED MIXED-METHODS GROUP INTERVENTION WITH MOTHERS OF CHILDREN WITH INTELLECTUAL DISABILITIES
The goal of this clinical trial is to learn whether an eight-week Mindfulness-Based Family Resilience Group Intervention can improve family resilience and mindfulness in mothers of children with intellectual disabilities. The intervention combines mindfulness practices with principles from Walsh's systemic family resilience model.
The main questions it aims to answer are:
Read more
- Does the intervention improve mothers' reported family resilience?
- Does the intervention improve mothers' mindfulness?
- How do mothers describe their caregiving experiences, parenting roles, and family life, and how do these experiences change during the intervention?
Researchers will compare mothers who receive the Mindfulness-Based Family Resilience Group Intervention with mothers in a control group who continue to receive usual care.
Participants in the intervention group will:
- Attend one group session per week for eight weeks, with each session lasting approximately 90 minutes.
- Take part in mindfulness practices and activities focused on awareness of thoughts, emotions, and bodily experiences, acceptance, self-compassion, and personal and family resources.
- Complete assessments of family resilience and mindfulness before the intervention, after the intervention, and at a three-month follow-up.
Participants in the control group will continue to receive usual care and will complete the same assessments at the same time points.
The study will also examine participants' experiences during the group intervention to better understand the processes that accompany changes in family resilience and mindfulness.
Read the detailed description
Mothers of children with intellectual disabilities may experience long-term caregiving demands that affect their emotional well-being, coping processes, and family life. Family resilience provides a systemic framework for understanding how families adapt to ongoing challenges by drawing on shared belief systems, organizational resources, communication, and problem-solving processes. Mindfulness, in turn, emphasizes present-moment awareness and a nonjudgmental approach to thoughts, emotions, and bodily experiences. Integrating these two approaches may provide a way to support both individual awareness and family-related coping resources.
The Mindfulness-Based Family Resilience Group Intervention was developed by integrating Walsh's systemic family resilience framework with core mindfulness principles and practices. The program was designed to help mothers become more aware of their thoughts, emotions, and bodily responses; relate to difficult experiences with greater acceptance and self-compassion; recognize automatic patterns of responding; and identify personal and family strengths and resources. Family resilience processes, including meaning-making, organizational patterns, communication, and problem solving, were addressed alongside mindfulness-based experiential practices.
The intervention consisted of eight weekly group sessions, each lasting approximately 90 minutes. Across the program, participants engaged in practices involving breath and body awareness, present-moment attention, nonjudgmental observation of thoughts and emotions, acceptance, self-compassion, emotion regulation, and reflection on personal and family resources. Experiential exercises and group discussions were used to connect mindfulness practices with participants' caregiving experiences, parenting roles, and family relationships.
The study used a randomized controlled, embedded mixed-methods design. The quantitative component was designed to evaluate changes in family resilience and mindfulness over time and to compare these changes between the intervention and usual-care control conditions. The qualitative component was embedded within the intervention process to provide a more detailed understanding of participants' experiences and the processes accompanying change.
Qualitative information obtained from group-session recordings and field notes was examined using thematic analysis. This component focused on how participants described and made sense of their caregiving experiences, difficult thoughts and emotions, parenting roles, personal and family resources, and changes experienced during the intervention. Integrating the quantitative and qualitative components was intended to provide a broader understanding of both changes in the measured outcomes and the experiential processes accompanying those changes.
- Conditions
- Family Resilience, Mindfulness
- Being tested
- Mindfulness-Based Family Resilience Group Intervention
- Keywords
- Family resilience, Mindfulness, Intellectual disability, Mothers, Mindfulness-based intervention, 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.
Mindfulness-Based Family Resilience Group InterventionBehavioural
The Mindfulness-Based Family Resilience Group Intervention was an eight-week, group-based behavioral intervention integrating mindfulness practices with Walsh's systemic family resilience framework. The intervention was delivered once weekly, with each session lasting approximately 90 minutes. The eight sessions focused sequentially on: (1) building safety and awareness, (2) acceptance of emotions and self-compassion, (3) values and meaning-making, (4) acceptance of uncertainty, (5) flexible problem solving, (6) discovering family strengths, (7) consolidating gains and relapse prevention, and (8) integration and closure. Core mindfulness components included breath and body awareness, acceptance-based mindfulness, values-focused mindfulness, cognitive defusion and observing thoughts, strength-focused mindfulness, the three-minute breathing space, and compassion and gratitude meditation. Experiential and group activities were used to support emotional awareness, acceptance, psychological
| Study group | Role | What they receive |
|---|---|---|
| Change in Family Resilience and Change in Mindfulness | Experimental | Participants assigned to the experimental arm received the eight-week Mindfulness-Based Family Resilience Group Intervention. The intervention was delivered once weekly, with each group session lasting approximately 90 minutes. The program integrated Walsh's systemic family resilience framework with mindfulness-based practices, including breath and body awareness, nonjudgmental observation of thoughts and emotions, acceptance, self-compassion, emotion regulation, and activities aimed at identifying personal and family resources. Receives: Behavioral: Mindfulness-Based Family Resilience Group Intervention |
| Control Group | No intervention | Participants assigned to the control group continued to receive usual care during the study period and did not receive the Mindfulness-Based Family Resilience Group Intervention. They completed the same outcome assessments as the experimental group at baseline, post-intervention, and the three-month follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Resilience Scale (FRS)
Family resilience was assessed using the Family Resilience Scale (FRS), developed by Kaner and Bayraklı (2010). The scale consists of 37 items rated on a 5-point Likert scale ranging from 1 ("Does not describe me at all") to 5 ("Describes me very well"). Total scores range from 37 to 185, with higher scores indicating higher levels of family resilience. The scale includes four subscales: Resilience/Challenge (17 items), Self-Efficacy (9 items), Commitment to Life (8 items), and Control (3 items).
Measured: Baseline (March 13, 2026), immediately post-intervention (May 1, 2026), and 3-month follow-up (July 31, 2026)
Mindful Attention Awareness Scale (MAAS)
Mindfulness was assessed using the Mindful Attention Awareness Scale (MAAS), developed by Brown and Ryan (2003). The scale consists of 15 items rated on a 6-point Likert scale ranging from 1 ("Almost always") to 6 ("Almost never"). Total scores range from 15 to 90, with higher scores indicating higher levels of mindful attention and awareness. The Turkish adaptation, validity, and reliability study of the scale was conducted by Özyeşil et al. (2011).
Measured: Baseline (March 13, 2026), immediately post-intervention (May 1, 2026), and 3-month follow-up (July 31, 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start13 Mar 2026
- Primary completion1 May 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family 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
- This study used a two-arm, parallel-group randomized controlled design. Participants were randomly assigned to either the intervention group or the control group. The intervention group received the eight-week Mindfulness-Based Family Resilience Group Intervention, delivered once weekly in approximately 90-minute group sessions. The control group continued to receive usual care. Both groups were assessed before the intervention, immediately after the intervention, and at the three-month follow-up.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT07816653
- Sponsor's protocol ID
- 2025/613
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 14 Sep 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 made publicly available because of participant confidentiality and privacy considerations. The study included a relatively small sample and qualitative data derived from group-session recordings and field notes, which may increase the risk of participant identification even after de-identification. In addition, specific consent for public sharing of individual participant data was not obtained from participants. Aggregate study findings will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRENGTHENING FAMILY RESILIENCE THROUGH MINDFULNESS: A RANDOMIZED CONTROLLED MIXED-METHODS GROUP INTERVENTION WITH MOTHERS OF CHILDREN WITH INTELLECTUAL DISABILITIES
- ClinicalTrials.gov ID
- NCT07816653
- Acronym / sponsor ID
- 2025/613
- Conditions
- Family Resilience, Mindfulness
- Keywords
- Family resilience, Mindfulness, Intellectual disability, Mothers, Mindfulness-based intervention, Mixed methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 14 Sep 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.
The goal of this clinical trial is to learn whether an eight-week Mindfulness-Based Family Resilience Group Intervention can improve family resilience and mindfulness in mothers of children with intellectual disabilities. The intervention combines mindfulness practices with principles from Walsh's systemic family resilience model.
The main questions it aims to answer are:
- Does the intervention improve mothers' reported family resilience?
- Does the intervention improve mothers' mindfulness?
- How do mothers describe their caregiving experiences, parenting roles, and family life, and how do these experiences change during the intervention?
Researchers will compare mothers who receive the Mindfulness-Based Family Resilience Group Intervention with mothers in a control group who continue to receive usual care.
Participants in the intervention group will:
- Attend one group session per week for eight weeks, with each session lasting approximately 90 minutes.
- Take part in mindfulness practices and activities focused on awareness of thoughts, emotions, and bodily experiences, acceptance, self-compassion, and personal and family resources.
- Complete assessments of family resilience and mindfulness before the intervention, after the intervention, and at a three-month follow-up.
Participants in the control group will continue to receive usual care and will complete the same assessments at the same time points.
The study will also examine participants' experiences during the group intervention to better understand the processes that accompany changes in family resilience and mindfulness.
Detailed description
Mothers of children with intellectual disabilities may experience long-term caregiving demands that affect their emotional well-being, coping processes, and family life. Family resilience provides a systemic framework for understanding how families adapt to ongoing challenges by drawing on shared belief systems, organizational resources, communication, and problem-solving processes. Mindfulness, in turn, emphasizes present-moment awareness and a nonjudgmental approach to thoughts, emotions, and bodily experiences. Integrating these two approaches may provide a way to support both individual awareness and family-related coping resources.
The Mindfulness-Based Family Resilience Group Intervention was developed by integrating Walsh's systemic family resilience framework with core mindfulness principles and practices. The program was designed to help mothers become more aware of their thoughts, emotions, and bodily responses; relate to difficult experiences with greater acceptance and self-compassion; recognize automatic patterns of responding; and identify personal and family strengths and resources. Family resilience processes, including meaning-making, organizational patterns, communication, and problem solving, were addressed alongside mindfulness-based experiential practices.
The intervention consisted of eight weekly group sessions, each lasting approximately 90 minutes. Across the program, participants engaged in practices involving breath and body awareness, present-moment attention, nonjudgmental observation of thoughts and emotions, acceptance, self-compassion, emotion regulation, and reflection on personal and family resources. Experiential exercises and group discussions were used to connect mindfulness practices with participants' caregiving experiences, parenting roles, and family relationships.
The study used a randomized controlled, embedded mixed-methods design. The quantitative component was designed to evaluate changes in family resilience and mindfulness over time and to compare these changes between the intervention and usual-care control conditions. The qualitative component was embedded within the intervention process to provide a more detailed understanding of participants' experiences and the processes accompanying change.
Qualitative information obtained from group-session recordings and field notes was examined using thematic analysis. This component focused on how participants described and made sense of their caregiving experiences, difficult thoughts and emotions, parenting roles, personal and family resources, and changes experienced during the intervention. Integrating the quantitative and qualitative components was intended to provide a broader understanding of both changes in the measured outcomes and the experiential processes accompanying those changes.
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
- This study used a two-arm, parallel-group randomized controlled design. Participants were randomly assigned to either the intervention group or the control group. The intervention group received the eight-week Mindfulness-Based Family Resilience Group Intervention, delivered once weekly in approximately 90-minute group sessions. The control group continued to receive usual care. Both groups were assessed before the intervention, immediately after the intervention, and at the three-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Change in Family Resilience and Change in Mindfulness | Experimental | Behavioral: Mindfulness-Based Family Resilience Group InterventionParticipants assigned to the experimental arm received the eight-week Mindfulness-Based Family Resilience Group Intervention. The intervention was delivered once weekly, with each group session lasting approximately 90 minutes. The program integrated Walsh's systemic family resilience framework with mindfulness-based practices, including breath and body awareness, nonjudgmental observation of thoughts and emotions, acceptance, self-compassion, emotion regulation, and activities aimed at identifying personal and family resources. |
| Control Group | No intervention | –Participants assigned to the control group continued to receive usual care during the study period and did not receive the Mindfulness-Based Family Resilience Group Intervention. They completed the same outcome assessments as the experimental group at baseline, post-intervention, and the three-month follow-up. |
Who may qualify
- Ages
- 27 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- * Mothers of children aged 9-17 years.
Key exclusion criteria (3 listed)
- Mothers whose children had severe intellectual disability.
- Not meeting the predefined inclusion criteria.
- Declining to participate in 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 |
|---|---|---|
| Mindfulness-Based Family Resilience Group InterventionThe Mindfulness-Based Family Resilience Group Intervention was an eight-week, group-based behavioral intervention integrating mindfulness practices with Walsh's systemic family resilience framework. The intervention was delivered once weekly, with each session lasting approximately 90 minutes. The eight sessions focused sequentially on: (1) building safety and awareness, (2) acceptance of emotions and self-compassion, (3) values and meaning-making, (4) acceptance of uncertainty, (5) flexible problem solving, (6) discovering family strengths, (7) consolidating gains and relapse prevention, and (8) integration and closure. Core mindfulness components included breath and body awareness, acceptance-based mindfulness, values-focused mindfulness, cognitive defusion and observing thoughts, strength-focused mindfulness, the three-minute breathing space, and compassion and gratitude meditation. Experiential and group activities were used to support emotional awareness, acceptance, psychological | Behavioural | Change in Family Resilience and Change in Mindfulness |
Primary outcome
Family Resilience Scale (FRS)
Time frame: Baseline (March 13, 2026), immediately post-intervention (May 1, 2026), and 3-month follow-up (July 31, 2026)
Family resilience was assessed using the Family Resilience Scale (FRS), developed by Kaner and Bayraklı (2010). The scale consists of 37 items rated on a 5-point Likert scale ranging from 1 ("Does not describe me at all") to 5 ("Describes me very well"). Total scores range from 37 to 185, with higher scores indicating higher levels of family resilience. The scale includes four subscales: Resilience/Challenge (17 items), Self-Efficacy (9 items), Commitment to Life (8 items), and Control (3 items).
Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline (March 13, 2026), immediately post-intervention (May 1, 2026), and 3-month follow-up (July 31, 2026)
Mindfulness was assessed using the Mindful Attention Awareness Scale (MAAS), developed by Brown and Ryan (2003). The scale consists of 15 items rated on a 6-point Likert scale ranging from 1 ("Almost always") to 6 ("Almost never"). Total scores range from 15 to 90, with higher scores indicating higher levels of mindful attention and awareness. The Turkish adaptation, validity, and reliability study of the scale was conducted by Özyeşil et al. (2011).
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because of participant confidentiality and privacy considerations. The study included a relatively small sample and qualitative data derived from group-session recordings and field notes, which may increase the risk of participant identification even after de-identification. In addition, specific consent for public sharing of individual participant data was not obtained from participants. Aggregate study findings will be reported in scientific publications.
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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 Mindfulness-Based Family Resilience Group Intervention in people with Family Resilience and Mindfulness, 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 3 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 14 Sep 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?
Family Resilience Scale (FRS) (time frame: Baseline (March 13, 2026), immediately post-intervention (May 1, 2026), and 3-month follow-up (July 31, 2026)). The study lists 2 primary outcomes in all. 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 14 Sep 2026.