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Effects of Developmental Support for Mothers of Infants With Spinal Muscular Atrophy

NCT07547189 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-04-23

No results posted yet for this study

Summary

Spinal muscular atrophy (SMA) is an autosomal recessive neurodegenerative disorder causing progressive muscle weakness and atrophy. This mixed-methods study aims to provide developmental support to mothers of infants (aged 12-36 months) with SMA Type 1 and to evaluate its impact on infants' developmental outcomes and mothers' developmental knowledge.

Participants will include 13 mothers recruited via purposive sampling from a university hospital's Pediatric Chest Diseases Outpatient Clinic. Inclusion criteria require mothers to have infants with SMA Type 1 who are receiving pharmacological treatment and do not have a tracheostomy. Ten mothers will be assigned to the intervention group, and three to the control group.

Data will be gathered using quantitative and qualitative tools. Quantitative instruments include a General Information Form, the Ages and Stages Questionnaires (ASQ) and its Social-Emotional version (ASQ-SE) for developmental progress, and the researcher-adapted Caregiver Knowledge of Child Development Inventory (CKCDI). Qualitative data will be collected via "Parental reflections on developmental support" from the intervention group.

The intervention consists of a 12-week online developmental support program, held once weekly for 90 minutes. Post-test measurements will be administered to both groups immediately after the intervention, followed by a retention test for the intervention group four weeks later. Finally, prioritizing the children's best interests, the control group will receive a four-session developmental support program after the study concludes.

Conditions

Interventions

BEHAVIORAL

Online Early Intervention Program for Infants with SMA Type 1

A 12-week online program designed and implemented by the researcher for mothers of infants diagnosed with SMA Type 1. Conducted once a week for 90 minutes, the program provides education and guidance to support infants' overall development and enhance parental knowledge and coping skills. Post-test assessments are conducted at the end of the program, and a retention test is administered 4 weeks later. Applied only to the Intervention Group.

OTHER

Standard Care

Routine medical care without additional developmental support. Applied to the Control Group during the study.

Sponsors & Collaborators

  • Istanbul Medipol University Hospital

    collaborator OTHER

  • Medipol University

    lead OTHER

Principal Investigators

  • Aysil S TOGUR, MSc · Ankara University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2026-06-30
Completion
2026-08-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07547189 on ClinicalTrials.gov