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NCT Number: NCT07387627

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

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.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorders Neurodevelopmental Disorders and Developmental Abnormalities

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escuela Infantil El Nido de los Perdigones

Seville, 41009, Spain

Location status: Recruiting

Location contact

Elena Pinero-Pinto

CONTACT

[email protected]

+34 655108763

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Coping with and Caring for Infants with Special Needs

Other

COPCA®-based intervention focused on caregiver coaching and promotion of infant motor initiative and variability. Delivered weekly for up to 45 minutes over 6 months, either in person or online after an initial in-person assessment, integrated into daily routines and emphasizing self-exploration.

Parental Education Program

Other

Online group-based parental education on motor development and home stimulation, delivered in 90-minute sessions every two weeks for 6 months, without individualized child intervention.

Conventional Pediatric Physiotherapy

Other

Standard pediatric physiotherapy delivered according to routine clinical practice in Early Intervention services. The intervention consists of therapist-led sessions using structured exercises and movement facilitation techniques, with frequency and duration determined by the reference center.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Family Empowerment Scale (FES)

    Time frame: Post-intervention (6 months)

    Assessment of family empowerment and perceived impact of the intervention. Items are rated on a 5-point Likert scale (1 to 5), where higher scores indicate greater family empowerment.

  2. Semi-structured interview

    Time frame: Post-intervention (6 months)

    Qualitative exploration of family experiences, perceived usefulness of the intervention, and challenges in home implementation. This outcome does not use a numerical scale. Data will be analyzed using qualitative content analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Miryam Quintano-Villar, PT

CONTACT

[email protected]

+34 633665237

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Acronym: COPCA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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