Down SyndromeNCT06197035
The Coping With and Caring for Infants With Special Needs Intervention in Down Syndrome Infants
A study testing Coping With and Caring for Infants With Special Needs and Standard Physiotherapy in people with Down Syndrome and Family, run by University of Seville at 1 site in Spain.
Trial summary
The objective is to compare the impact of standard infant physical therapy and the family-centered program, Coping with and Caring for Infants with Special Needs (COPCA), on infants born with Down syndrome. Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- Down Syndrome, Family, Physical Disability
- What is being tested?
- Coping With and Caring for Infants With Special Needs and Standard Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2024to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 month to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies with Down syndrome
- Families involved in Pediatric Physical Therapy
Who cannot join
- Other associated developmental disorders
- To not speak Spanish
- Do not sign informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Seville
Seville
Piñero Pinto, PhD, +34655108763, epinero@us.es
About this study
Official title: Coping and Caring for Families With Babies With Down Syndrome. A Family-centered Intervention
The objective is to compare the impact of standard infant physical therapy and the family-centered program, Coping with and Caring for Infants with Special Needs (COPCA), on infants born with Down syndrome. This is a randomized controlled trial that will be carried out in the patients' homes and outpatient settings in Spain between January 2024 and March 2024. An evaluation battery will be used that includes child and family outcomes and video analysis of therapy sessions.
The Infant Motor profile will be the primary outcome instrument.
- Conditions
- Down Syndrome, Family, Physical Disability
- Being tested
- Coping With and Caring for Infants With Special Needs, Standard Physiotherapy
- Medical subject headings
- Down Syndrome
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 NeedsProcedure or surgery
The early intervention programme for infants and young children focuses on the active inclusion of the whole family. The coaching of parents is a central component. Parents learn how they can independently and optimally support their child's development as part of the child's everyday life. The programme was developed at the beginning of the 2000s in the Netherlands by child physiotherapist Tineke Dirks and professor of developmental neurology Mijna Hadders-Algra.
Standard PhysiotherapyProcedure or surgery
Pediatric physiotherapy techniques aimed at improving the development of the baby and young child from manual therapy tools, or baby management.
| Study group | Role | What they receive |
|---|---|---|
| COPCA (Coping With and Caring for Infants With Special Needs) Intervention | Experimental | The intervention will be delivered by COPCA coaches who follow the programme's theoretical and practical principles. Caregivers learnt how to stimulate their infant's development by challenging their motor behaviour with trial and error experiences.
This aim to empower the caregivers' competencies to stimulate the infant's daily development, by increasing their motor repertoire.
and enhancing their capacity to adapt movements to situations. Receives: Procedure: Coping With and Caring for Infants With Special Needs |
| Standard physiotherapy | Active comparator | Standard care will be based on what paediatric physiotherapists generally assume to be useful to promote the development of infants with special needs. Standard care is heterogeneous and eclectic, uses parent training and often includes components of neurodevelopmental treatment with hands-on techniques. Receives: Procedure: Standard Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Development
INFANT MOTOR PROFILE Results achieved between the 10% and 90% percentiles indicate adequate motor development. Results between the 5% and 10% percentiles indicate a risk for delays or problems in gross motor development.
Measured: 3-6-18 months.
Secondary outcomes (1)
Family empowerment
Family Empowerment Scale
There are 28 items to be answered by the family with these options:
1= Strongly Agree' 2= Agree' 3= Disagree' 4= Strongly Disagree. The higher the score, the greater the empowerment.
Measured: 3-6-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start10 Mar 2024
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Model description
- Two intervention groups, a group with COPCA intervention and a group with standard physiotherapy
- Masking
- Double blind
- Who is masked
- Investigator, 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
- Investigators
- Elena Pinero-Pinto, PhD, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197035
- Sponsor's protocol ID
- USeville-EPINTO
- Status last verified
- Mar 2024
- First submitted
- 25 Dec 2023
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The publication of the results of this research is planned.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping and Caring for Families With Babies With Down Syndrome. A Family-centered Intervention
- ClinicalTrials.gov ID
- NCT06197035
- Acronym / sponsor ID
- USeville-EPINTO
- Conditions
- Down Syndrome, Family, Physical Disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 9 Jan 2024 (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 objective is to compare the impact of standard infant physical therapy and the family-centered program, Coping with and Caring for Infants with Special Needs (COPCA), on infants born with Down syndrome. This is a randomized controlled trial that will be carried out in the patients' homes and outpatient settings in Spain between January 2024 and March 2024. An evaluation battery will be used that includes child and family outcomes and video analysis of therapy sessions.
The Infant Motor profile will be the primary outcome instrument.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two intervention groups, a group with COPCA intervention and a group with standard physiotherapy
| Arm | Type | Receives |
|---|---|---|
| COPCA (Coping With and Caring for Infants With Special Needs) Intervention | Experimental | Procedure: Coping With and Caring for Infants With Special NeedsThe intervention will be delivered by COPCA coaches who follow the programme's theoretical and practical principles. Caregivers learnt how to stimulate their infant's development by challenging their motor behaviour with trial and error experiences. This aim to empower the caregivers' competencies to stimulate the infant's daily development, by increasing their motor repertoire. and enhancing their capacity to adapt movements to situations. |
| Standard physiotherapy | Active comparator | Procedure: Standard PhysiotherapyStandard care will be based on what paediatric physiotherapists generally assume to be useful to promote the development of infants with special needs. Standard care is heterogeneous and eclectic, uses parent training and often includes components of neurodevelopmental treatment with hands-on techniques. |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Babies with Down syndrome
- Families involved in Pediatric Physical Therapy
Key exclusion criteria (3 listed)
- Other associated developmental disorders
- To not speak Spanish
- Do not sign informed consent
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 NeedsThe early intervention programme for infants and young children focuses on the active inclusion of the whole family. The coaching of parents is a central component. Parents learn how they can independently and optimally support their child's development as part of the child's everyday life. The programme was developed at the beginning of the 2000s in the Netherlands by child physiotherapist Tineke Dirks and professor of developmental neurology Mijna Hadders-Algra. | Procedure or surgery | COPCA (Coping With and Caring for Infants With Special Needs) Intervention |
| Standard PhysiotherapyPediatric physiotherapy techniques aimed at improving the development of the baby and young child from manual therapy tools, or baby management. | Procedure or surgery | Standard physiotherapy |
Primary outcome
Motor Development
Time frame: 3-6-18 months.
INFANT MOTOR PROFILE Results achieved between the 10% and 90% percentiles indicate adequate motor development. Results between the 5% and 10% percentiles indicate a risk for delays or problems in gross motor development.
1 secondary outcome
Family empowerment
Time frame: 3-6-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: Yes. The publication of the results of this research is planned.
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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. This study is not recruiting at the moment.
Elena Pinero-Pinto, PhD study director
University of Seville
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 and Standard Physiotherapy in people with Down Syndrome and Family, 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 2 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Pinero-Pinto, PhD (+34655108763, epinero@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Development (time frame: 3-6-18 months.). 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 1 Apr 2024.