Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders.

University of Seville

Status: Begins enrollment this month

Conditions: Neurodevelopmental Disorders; Neurodevelopmental Disorders and Developmental Abnormalities

Treatments: Other: Conventional Pediatric Physiotherapy; Other: Coping with and Caring for Infants with Special Needs; Other: Parental Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07387627

SICEIA-2025-003712 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 4 patient groups

In-person COPCA® Intervention

Experimental group

Description:

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.

Treatment:

Other: Coping with and Caring for Infants with Special Needs

Online COPCA® Intervention

Active Comparator group

Description:

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.

Treatment:

Other: Parental Education Program

Parental Education Group

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Pediatric Physiotherapy

Conventional Pediatric Physiotherapy

Active Comparator group

Description:

Standard pediatric physiotherapy delivered according to usual clinical practice in Early Intervention services, with therapist-led sessions using structured exercises and movement facilitation techniques.

Treatment:

Other: Coping with and Caring for Infants with Special Needs