Neurodevelopmental DisordersCOPCANCT07387627
Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders
A study testing Coping with and Caring for Infants with Special Needs, Parental Education Program and Conventional Pediatric Physiotherapy in people with Neurodevelopmental Disorders and Neurodevelopmental Disorders and Developmental Abnormalities, run by University of Seville at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Neurodevelopmental Disorders, Neurodevelopmental Disorders and Developmental Abnormalities
- What is being tested?
- Coping with and Caring for Infants with Special Needs, Parental Education Program and Conventional Pediatric Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Escuela Infantil El Nido de los Perdigones
Seville, Seville, 41009
Elena Pinero-Pinto, +34 655108763, epinero@us.es
About this study
Official 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
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.
Read more
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.
- Conditions
- Neurodevelopmental Disorders, Neurodevelopmental Disorders and Developmental Abnormalities
- Being tested
- Coping with and Caring for Infants with Special Needs, Parental Education Program, Conventional Pediatric Physiotherapy
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping with and Caring for Infants with Special NeedsOther
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 ProgramOther
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 PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| In-person COPCA® Intervention | Experimental | 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. Receives: Other: Coping with and Caring for Infants with Special Needs |
| Online COPCA® Intervention | Active comparator | 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. Receives: Other: Parental Education Program |
| Parental Education Group | Active comparator | 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. Receives: Other: Conventional Pediatric Physiotherapy |
| Conventional Pediatric Physiotherapy | Active comparator | Standard pediatric physiotherapy delivered according to usual clinical practice in Early Intervention services, with therapist-led sessions using structured exercises and movement facilitation techniques. Receives: Other: Coping with and Caring for Infants with Special Needs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Motor Profile (IMP)
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.
Measured: Baseline, during intervention (3 months), post-intervention (6 months) and follow up (3 and 6 months after intervention)
Pediatric Evaluation of Disability Inventory (PEDI)
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.
Measured: Baseline, during intervention (3 months), post-intervention (6 months) and follow-up after intervention (3 and 6 months)
Merrill-Palmer-Revised Scales of Development (MP-R)
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.
Measured: Baseline, post-intervention (6 months) and follow-up (6 months after intervention)
Measurement of Processes of Care (MPOC-20)
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.
Measured: Post-intervention (6 months)
Secondary outcomes (2)
Family Empowerment Scale (FES)
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.
Measured: Post-intervention (6 months)
Semi-structured interview
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.
Measured: Post-intervention (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start10 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Piñero Pinto, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387627
- Sponsor's protocol ID
- SICEIA-2025-003712
- Other IDs
- SICEIA-2025-003712
- Acronym
- COPCA
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing data
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07387627
- Acronym / sponsor ID
- COPCA / SICEIA-2025-003712
- Conditions
- Neurodevelopmental Disorders, Neurodevelopmental Disorders and Developmental Abnormalities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| In-person COPCA® Intervention | Experimental | Other: Coping with and Caring for Infants with Special NeedsCOPCA®-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. |
| Online COPCA® Intervention | Active comparator | Other: Parental Education ProgramCOPCA®-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. |
| Parental Education Group | Active comparator | Other: Conventional Pediatric PhysiotherapyOnline group-based parental education on motor development and home stimulation, without individualized child intervention. Sessions of 90 minutes every two weeks for 6 months. |
| Conventional Pediatric Physiotherapy | Active comparator | Other: Coping with and Caring for Infants with Special NeedsStandard pediatric physiotherapy delivered according to usual clinical practice in Early Intervention services, with therapist-led sessions using structured exercises and movement facilitation techniques. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping with and Caring for Infants with Special NeedsCOPCA®-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. | Other | Conventional Pediatric Physiotherapy, In-person COPCA® Intervention |
| Parental Education ProgramOnline 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. | Other | Online COPCA® Intervention |
| Conventional Pediatric PhysiotherapyStandard 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. | Other | Parental Education Group |
Primary outcome
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.
2 secondary outcomes
Family Empowerment Scale (FES)
Time frame: Post-intervention (6 months)
Semi-structured interview
Time frame: Post-intervention (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Sharing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping with and Caring for Infants with Special Needs, Parental Education Program and Conventional Pediatric Physiotherapy in people with Neurodevelopmental Disorders and Neurodevelopmental Disorders and Developmental Abnormalities, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miryam Quintano-Villar, PT (+34 633665237, mquintano@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Motor Profile (IMP) (time frame: Baseline, during intervention (3 months), post-intervention (6 months) and follow up (3 and 6 months after intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.