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

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Summary

This ClinicalTrials.gov registry entry describes a mixed-methods study conducted at a university hospital's Pediatric Chest Diseases Outpatient Clinic, recruiting 13 mothers of infants aged 12–36 months with Spinal Muscular Atrophy (SMA) Type 1. Ten mothers will receive a 12-week online developmental support program (once weekly, 90 minutes per session), while three mothers will serve as controls receiving standard care. The study will evaluate infant developmental outcomes using the Ages and Stages Questionnaires (ASQ and ASQ-SE) and assess maternal developmental knowledge through the Caregiver Knowledge of Child Development Inventory (CKCDI).

“Ten mothers will be assigned to the intervention group, and three to the control group.”

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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This ClinicalTrials.gov registry entry documents the launch of an interventional study (NCT07547189) examining developmental support for mothers of infants with SMA Type 1. The study uses a quasi-experimental design with 10 participants in an intervention group receiving weekly 90-minute online sessions over 12 weeks and 3 participants in a control group receiving standard care. Outcome measures include infant developmental progress (ASQ, ASQ-SE) and maternal knowledge of child development (CKCDI), with follow-up assessments at 4 weeks post-intervention.

Healthcare providers and clinical investigators involved in rare pediatric neurology or developmental care should note this registry entry as evidence of ongoing research into integrated maternal-infant support models for neurodegenerative conditions. The study's inclusion criteria (infants receiving pharmacological treatment without tracheostomy) may inform eligibility considerations for similar trials or clinical programs.

Archived snapshot

Apr 24, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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

N/A NCT07547189 Kind: NA Apr 23, 2026

Abstract

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 interes...

Conditions: Spinal Muscular Atrophy, Developmental Delay

Interventions: Online Early Intervention Program for Infants with SMA Type 1, Standard Care

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Last updated

Classification

Agency
NIH
Published
April 23rd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Pediatric neurology research Maternal-infant developmental support
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Public Health

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