Clinical Trial

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

Completed
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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 included eight mothers of infants/children diagnosed with SMA Type 1 who were recruited through purposive sampling from a university hospital. Quantitative data were collected using a General Information Form, the Ages and Stages Questionnaires (ASQ), the Ages and Stages Questionnaires: Social-Emotional (ASQ-SE), and the Caregiver Knowledge of Child Development Inventory (CKCDI). Qualitative data were obtained through semi-structured interviews exploring mothers' experiences with the developmental support program. The intervention consisted of a 12-week online developmental support program delivered once a week for 90 minutes. Outcome assessments were conducted at baseline, immediately after the intervention, and four weeks after the intervention (follow-up assessment) to evaluate the sustainability of the intervention effects.
Protocol Amendment History 3 changes
critical Trial completed 2026-07-10
notable Enrollment reduced: 13 -> 8 participants 2026-07-10
minor Trial arms changed: 2 -> 1 2026-07-10
Trial Details
NCT Number NCT07547189
Lead Sponsor Medipol University
Collaborators: Istanbul Medipol University Hospital
Conditions Spinal Muscular Atrophy, Developmental Delay
Enrollment 8 participants
Start Date 2026-04-08
Primary Completion 2026-06-03 (estimated)
Study Completion 2026-07-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-09