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

NCT07547189 | Completed

• 1 other identifier: E-10840098-202.3.02-5419
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Muscular Atrophy; Developmental Delay

Keywords

Spinal Muscular Atrophy; Baby; Developmental Support; Parent Education

Outcome Measures

Primary Outcomes (2)

• Developmental progress measured by the Ages and Stages Questionnaires - Turkish Adaptation (ASQ)

  Developmental progress of infants aged 12-36 months diagnosed with SMA Type 1 will be assessed using ASQ. The scale evaluates communication, gross motor, fine motor, problem solving, and personal-social domains. Domain scores range from 0 to 60. Higher scores indicate better developmental performance.

  Baseline, Week 12, Week 16

• Social-emotional developmental progress measured by the Ages and Stages Questionnaires: Social-Emotional - Turkish Adaptation (ASQ-SE)

  Social-emotional development will be assessed using ASQ-SE. Total scores range from 0 to 60. Higher scores indicate better social-emotional development.

  Baseline, Week 12, Week 16

Secondary Outcomes (1)

• Caregiver Knowledge of Child Development Inventory "CKCDI"

  Baseline, Week 12, Week 16

Other Outcomes (1)

• Parental reflections on developmental support

  Week 12

Study Arms (1)

Intervention Group

EXPERIMENTAL

Participants' mothers received a 12-week online developmental support program designed for families of infants/children diagnosed with SMA Type 1. The program consisted of weekly 90-minute sessions and provided education and guidance on child development and family-centered developmental support. Outcome assessments were conducted at baseline, immediately after the intervention, and four weeks later (follow-up assessment).

Behavioral: Online Early Intervention Program for Infants with SMA Type 1

Interventions

Online Early Intervention Program for Infants with SMA Type 1 BEHAVIORAL

A 12-week online early intervention program designed and implemented by the researcher for mothers of infants/children diagnosed with SMA Type 1. Conducted once a week for 90 minutes, the program provided education and guidance to support children's overall development, enhance mothers' developmental knowledge, and promote family-centered developmental practices. Post-intervention assessments were conducted immediately after completion of the program, followed by a follow-up assessment four weeks later.

Also known as: SMA Type 1 Early Intervention Program

Intervention Group

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Medipol University: lead
• Istanbul Medipol University Hospital: collaborator

Study Sites (1)

ISTANBUL MEDIPOL UNIVERSITY - Department of Child Development

Istanbul, Beykoz, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Atrophy, Spinal; Learning Disabilities

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Aysil S TOGUR, MSc

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants were enrolled in a single-group pretest-posttest-follow-up study. Mothers of infants/children diagnosed with SMA Type 1 participated in a 12-week online early intervention program consisting of weekly 90-minute sessions. Outcome assessments were conducted at baseline, immediately after the intervention, and four weeks later to evaluate the sustainability of intervention effects. The program aimed to enhance mothers' developmental knowledge and support children's communication, gross motor, fine motor, problem-solving, personal-social, and social-emotional development through a family-centered early intervention approach.

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 23, 2026
• Study Start: April 8, 2026
• Primary Completion: June 3, 2026
• Study Completion: July 3, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)