NCT07816653

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

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

March 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 6, 2026

Last Update Submit

September 6, 2026

Conditions

Keywords

Family resilienceMindfulnessIntellectual disabilityMothersMindfulness-based interventionMixed methods

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    Baseline (March 13, 2026), immediately post-intervention (May 1, 2026), and 3-month follow-up (July 31, 2026)

Study Arms (2)

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.

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.

Interventions

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

Change in Family Resilience and Change in Mindfulness

Eligibility Criteria

Age27 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility was limited to women because the study was specifically designed for mothers of children with intellectual disabilities. The intervention focused on mothers' caregiving experiences, family resilience, and mindfulness; therefore, only mothers were included to maintain consistency with the predefined target population and intervention framework.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \* 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.

You may not qualify if:

  • Mothers whose children had severe intellectual disability.
  • Declining to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop University

Sinop, Sinop, 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
Masking Details
Participants and intervention facilitators were not blinded due to the nature of the group-based intervention. However, the datasets were coded so that group identities were concealed during statistical analysis, and the analyses were conducted without knowledge of group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

September 6, 2026

First Posted

September 14, 2026

Study Start

March 13, 2026

Primary Completion

May 1, 2026

Study Completion

July 21, 2026

Last Updated

September 14, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations