Self-Efficacy Enhancement Using a Multicomponent Support Group for Caregivers of Children With DMD/SMA (SEE-NMD)

January 21, 2026 updated by: Sara Khan, Aga Khan University

Effect of a Multicomponent Support Group on Self-Efficacy of Primary Caregivers of Children With Spinal Muscular Atrophy or Duchenne Muscular Dystrophy Enrolled in Treat-NMD Registry of Pakistan

The goal of this clinical trial is to learn if providing a multicomponent intervention improves the confidence of caregivers of children with DMD or SMA. The main question it aims to answer is:

Does this intervention increase their self-efficacy scores over 8 weeks time?

Researchers will compare scores at baseline (pre intervention) and after 8 weeks (post intervention)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMD) are severe neuromuscular disorders that significantly impact the lives of affected children and their families, placing immense pressure on primary caregivers who often experience diminished self-efficacy due to the complexities of caregiving. Both conditions necessitate specialized and time-consuming care, creating substantial challenges for caregivers.These challenges are compounded by the progressive nature of these diseases, which often leads to increased functional decline, discomfort, and respiratory dysfunction in affected children. The constant need for monitoring, administering medication, providing physical support, and managing medical equipment can be overwhelming and exhausting. The complex care requirements associated with SMA and DMD can also lead to social isolation, financial strain, and emotional distress for caregivers, effecting their overall quality of life and potentially reducing their confidence in their ability to manage their caregiving responsibilities. Therefore, understanding interventions that can bolster self-efficacy among primary caregivers of children with SMA or DMD is of paramount importance.

Self-efficacy, defined as an individual's belief in their capacity to execute behaviours necessary to produce specific performance attainments, plays a pivotal role in coping with chronic illnesses and their demanding care routines. When caregivers possess high self-efficacy, they are more likely to approach challenges with confidence, persevere through difficulties, and experience lower levels of stress and burnout. Conversely, low self-efficacy can result in feelings of helplessness, anxiety, and depression, which can ultimately compromise the quality of care provided to the child and their own well-being. Given the substantial impact of SMA and DMD on both the affected children and their caregivers, interventions aimed at enhancing self-efficacy are critical. One such intervention is participation in support groups, which provide caregivers with opportunities to share experiences, gain knowledge, and receive emotional support from others facing similar challenges. While traditional in-person support groups have been shown to be beneficial, they may not always be accessible to caregivers due to geographical limitations, time constraints, or transportation difficulties.

Online support groups have emerged as a promising alternative, offering convenience, accessibility, and anonymity, which may be particularly appealing to caregivers who are already burdened with numerous responsibilities and constraints. These online platforms can facilitate peer-to-peer support, professional guidance, and access to valuable resources, all from the comfort of one's own home. Furthermore, multicomponent support groups using online modalities can integrate various elements, such as educational videos, interactive discussions, and lectures by trained professionals like Neurologists, Nutritionists, Physiotherapists. These may be particularly effective in enhancing self-efficacy by addressing the multifaceted needs of caregivers. Considering the potential benefits of multicomponent support group for primary caregivers of children with SMA or DMD, and the increasing prevalence and duration of chronic illness, there is a need for array of supports for them.

This study is designed to evaluate the effect of a multicomponent support group on the self-efficacy of primary caregivers of children with SMA or DMD enrolled in the Treat-NMD registry of Pakistan. By examining the effect of this intervention, we hope to provide evidence-based recommendations for improving the well-being of caregivers and, ultimately, the quality of care for children with SMA and DMD. The findings from this study will have significant implications for healthcare providers, support organizations, and policymakers involved in the care of individuals with neuromuscular disorders and their families.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primary caregiver of a child diagnosed with SMA or DMD.
  • Enrolled in the Treat-NMD registry- Pakistan.
  • Access to a smart phone with internet connectivity.

Exclusion Criteria:

  • Caregivers who are currently participating in another support group intervention.
  • Caregivers who are unable to understand the language of communication (Urdu)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multicomponent Support Group Intervention for Caregivers of Children with DMD or SMA
Participants receive a structured, online multicomponent support group designed for primary caregivers of children with DMD or SMA enrolled in the Treat-NMD Registry of Pakistan. The intervention includes educational sessions, peer support discussions, and guidance from professionals in physiotherapy, respiratory care, occupational therapy, and psychosocial coping. Caregiver self-efficacy will be assessed before and after the intervention to measure changes associated with participation.
Behavioral: Multicomponent Support Group
A multifaceted strategy will be employed. Multiple groups will be created for SMA and DMD patients. Each group will include up to 10 patients caregivers, 1 neurologist, 1 pediatric neurologist, 1 physiotherapist, 1 nutritionist, 1 speech therapist, 1 occupational therapist, 1 epidemiologist and 1 Research Associate. Sessions with each group will integrate peer support, coaching to address the multifaceted needs of patients, and time for open questions and answer sessions with the group. The session with each group will be 1 hours duration. It will start with 5 minutes talk from each expert about the basic needs for SMA and DMD patients. Following the first session, after a few weeks gap, another similar 1 hour session will be conducted which will be open to care givers to ask questions off the specialists or other care givers. In between these 2 sessions, short videos or pictorial clips for care will be sent to the participants to re-enforce what they learnt from sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-Efficacy Scores
Time Frame: Baseline and 8 weeks

Change from Baseline in the Self-Efficacy Scores at 8 weeks. Care giver self efficacy tool is a 19-item self-report questionnaire adapted from the original validated scale developed for caregivers of individuals with DMD (DMD-CSES). The scale assesses caregiver self-efficacy across multiple domains of caregiving.

Each item is rated on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree).

Total scores range from 19 to 95, calculated by summing responses across all items.

Higher scores indicate greater caregiver self-efficacy (better outcome).
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Nashit Irfan Aziz, MBBS, MSc, Aga Khan University
  • Principal Investigator: Sara Khan, MBBS, MD, Aga Khan University
  • Principal Investigator: Wardah Khalid, MBBS, MSc, PhD, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 23, 2026

Primary Completion (Estimated)

March 23, 2026

Study Completion (Estimated)

May 23, 2026

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-11875-37040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Duchenne Muscular Dystrophy (DMD)

Clinical Trials on Multicomponent Support Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe