Effects of Developmental Support for Mothers of Infants With Spinal Muscular Atrophy (NCT07547189) | Clinical Trial Compass
CompletedNot Applicable
Effects of Developmental Support for Mothers of Infants With Spinal Muscular Atrophy
Turkey (Türkiye)8 participantsStarted 2026-04-08
Plain-language 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.
Who can participate
Age range
12 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Infants/children aged 12-36 months diagnosed with SMA Type 1 Infants/children receiving or having previously received any approved pharmacological treatment for SMA Type 1 Infants/children not receiving any developmental support intervention other than routine physical therapy and swallowing therapy Mothers who are the primary caregivers of the infants/children Mothers who are able to communicate in Turkish Mothers who voluntarily provide written informed consent and agree to participate in the intervention program
Exclusion Criteria Infants/children with a tracheostomy Infants/children younger than 12 months or older than 36 months Infants/children receiving any developmental intervention other than routine physical therapy and swallowing therapy Mothers who decline participation or withdraw informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Developmental progress measured by the Ages and Stages Questionnaires - Turkish Adaptation (ASQ)
Timeframe: Baseline, Week 12, Week 16
2
Social-emotional developmental progress measured by the Ages and Stages Questionnaires: Social-Emotional - Turkish Adaptation (ASQ-SE)