Effectiveness of the Coping With and Caring for Infants With Special Needs Program in Infants at Risk of Neurodevelopmental Disorders. A Comparison With Conventional Pediatric Physiotherapy Models and Parent Training
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Seville
- Enrollment
- 40
- Primary Endpoint
- Infant Motor Profile (IMP)
Study Overview
Brief Summary
The purpose of this clinical trial is to evaluate whether the COPCA® program (Coping with and Caring for Infants with Special Needs) is more effective than conventional pediatric physiotherapy and parent education in improving development in infants at risk of neurodevelopmental disorders, as well as empowering their families.
This study will include infants younger than 12 months of corrected age who are at risk of neurodevelopmental disorders and are currently receiving early intervention or pediatric physiotherapy services, together with their parents or primary caregivers.
The main questions this study aims to answer are:
Does the COPCA® program improve motor development and functional abilities in infants at risk of neurodevelopmental disorders more than conventional pediatric physiotherapy or parent education?
Does the COPCA® program increase family empowerment and improve parents' perception of the care they receive compared with traditional intervention models?
The researchers will compare outcomes across four study groups:
In-person COPCA® intervention
Online COPCA® intervention
Parent education group
Conventional pediatric physiotherapy group
Participants will be randomly assigned to one of the four groups. The intervention period will last 6 months, with assessments conducted at the start of the study, during the intervention, and during follow-up.
Infants will take part in age-appropriate daily activities and play situations. Parents or caregivers will actively participate in the intervention sessions and will be supported in learning how to promote their child's development during everyday routines.
The study will assess infant motor development, functional abilities, overall development, family empowerment, and parents' perception of family-centered care using validated assessment tools and interviews. The results of this study may help improve early intervention strategies for infants at risk of neurodevelopmental disorders and support more family-centered approaches to care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infants at risk of neurodevelopmental disorders.
- •Participation in pediatric physiotherapy and/or Early Intervention programs at the time of study inclusion, regardless of the reference center.
- •Corrected age under 12 months at the time of recruitment.
Exclusion Criteria
- •Infants with confirmed neurodevelopmental disorders at the time of inclusion.
- •Presence of additional medical conditions requiring complex medical or surgical interventions that could interfere with participation in the study (e.g., recent or planned surgery).
- •Severe family socio-communicative difficulties that limit participation in coaching sessions (e.g., significant language barriers).
Arms & Interventions
In-person COPCA® Intervention
COPCA®-based intervention focused on caregiver coaching and promotion of infant motor initiative and variability. One weekly in-person session at the family home, up to 45 minutes, for 6 months.
Intervention: Coping with and Caring for Infants with Special Needs (Other)
Online COPCA® Intervention
COPCA®-based intervention delivered via videoconferencing, focused on caregiver coaching and infant motor initiative and variability. One weekly session of up to 45 minutes for 6 months, following an initial in-person assessment.
Intervention: Parental Education Program (Other)
Parental Education Group
Online group-based parental education on motor development and home stimulation, without individualized child intervention. Sessions of 90 minutes every two weeks for 6 months.
Intervention: Conventional Pediatric Physiotherapy (Other)
Conventional Pediatric Physiotherapy
Standard pediatric physiotherapy delivered according to usual clinical practice in Early Intervention services, with therapist-led sessions using structured exercises and movement facilitation techniques.
Intervention: Coping with and Caring for Infants with Special Needs (Other)
Outcomes
Primary Outcomes
Infant Motor Profile (IMP)
Time Frame: Baseline, during intervention (3 months), post-intervention (6 months) and follow up (3 and 6 months after intervention)
Assessment of motor development and quality of motor behavior in infants. The IMP total score ranges from 0 to 100, where higher scores indicate better motor performance and motor behavior quality.
Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: Baseline, during intervention (3 months), post-intervention (6 months) and follow-up after intervention (3 and 6 months)
Assessment of functional abilities and performance in daily activities. Scaled scores range from 0 to 100, where higher scores indicate better functional performance and greater independence.
Merrill-Palmer-Revised Scales of Development (MP-R)
Time Frame: Baseline, post-intervention (6 months) and follow-up (6 months after intervention)
Assessment of overall development across cognitive, motor, and socio-emotional domains. Higher scores indicate higher developmental functioning. The score varies according to age so it does not have a general fixed minimum or maximum value.
Measurement of Processes of Care (MPOC-20)
Time Frame: Post-intervention (6 months)
Assessment of caregivers' perception of family-centered care. Items are rated on a 7-point Likert scale (1 to 7), where higher scores indicate a higher perception of family-centered care.
Secondary Outcomes
- Family Empowerment Scale (FES)(Post-intervention (6 months))
- Semi-structured interview(Post-intervention (6 months))
Investigators
Elena Piñero Pinto
PT, PhD
University of Seville