Developmental DelayNCT02115334
Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay
A study testing professional therapists delivering the PHPA, parents executing the PHPA and health education in people with Developmental Delay, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Early intervention refers to the provision of early detection, early diagnosis, and early intervention for infants and young children with special needs. The implementation of home programs is very important for children with developmental delay (DD). Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay
- What is being tested?
- professional therapists delivering the PHPA, parents executing the PHPA and health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2011to Jul 2014
- 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 Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 0 to 6-years-old children
- clinical diagnosis of DD and other related disorders
Who cannot join
- unstable physiological conditions
- progression or regression symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay:a Randomized Controlled Trial.
Early intervention refers to the provision of early detection, early diagnosis, and early intervention for infants and young children with special needs. The implementation of home programs is very important for children with developmental delay (DD). Therefore, the purposes of this study are to: (1) design the preschool home program activities(PHPA), (2) investigate the immediate efficacy of PHPA for children with DD, (3) investigate the long-term efficacy of PHPA for children with DD.The second year is to investigate the immediate efficacy of PHPA for children with DD.
Read the detailed description
A total of 36 children with DD, aged 2-6 years, were randomly assigned to the professional-based group (professional therapists delivering the PHPA, total n=13), parents-based group (parents executing the PHPA, n=12) and control group (health education only, n=11). Outcome measures included clinical assessments and subjective questionnaires. The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT). The subjective questionnaires were Chinese Child Developmental Inventory (CCDI), Assessment of preschool children's participation (APCP), TN0-AZL Preschool quality of life (TAPQOL) and parent stress index (PSI). Tests were administrated before and after the intervention.
- Conditions
- Developmental Delay
- Being tested
- professional therapists delivering the PHPA, parents executing the PHPA, health education
- Keywords
- Developmental delay, Early Intervention, Home programs, Preschool activities
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
professional therapists delivering the PHPABehavioural
Also called PHPA(delivered by professional therapists)
PHPA are delivered by professional therapists, which including gross motor, fine motor, cognition verbal, social interactions, activity of daily living(ADL).
parents executing the PHPABehavioural
Also called PHPA (executed by parents)
PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL.
health educationBehavioural
health education of the children with DD.
| Study group | Role | What they receive |
|---|---|---|
| professional-based group | Experimental | professional therapists delivering the PHPA Receives: Behavioral: professional therapists delivering the PHPA |
| parents-based group | Experimental | parents executing the PHPA Receives: Behavioral: parents executing the PHPA |
| control group | Active comparator | health education only Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 months
The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT).
Measured: baseline, 8 weeks, 3 months, 6 months
Secondary outcomes (4)
change from baseline in Chinese Child Developmental Inventory (CCDI) after 8 weeks intervention of PHPA at 6 months
Measurement of CCDI.
Measured: baseline, 8 weeks, 3 months, 6 months
change from baseline in Assessment of preschool children's participation(APCP) after 8 weeks intervention of PHPA at 6 months
Measurement of APCP.
Measured: baseline, 8 weeks, 3 months, 6 months
change from baseline in TN0-AZL Preschool quality of life (TAPQOL) after 8 weeks intervention of PHPA at 6 months
Measurement of TAPQOL.
Measured: baseline, 8 weeks, 3 months, 6 months
change from baseline in parent stress index (PSI) after 8 weeks intervention of PHPA at 6 months
Measurement of PSI.
Measured: baseline, 8 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMay 2011
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelayStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD,PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115334
- Sponsor's protocol ID
- 100-0996A3
- Status last verified
- Jun 2011
- First submitted
- 27 Sep 2013
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay:a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02115334
- Acronym / sponsor ID
- 100-0996A3
- Conditions
- Developmental Delay
- Keywords
- Developmental delay, Early Intervention, Home programs, Preschool activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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.
Early intervention refers to the provision of early detection, early diagnosis, and early intervention for infants and young children with special needs. The implementation of home programs is very important for children with developmental delay (DD). Therefore, the purposes of this study are to: (1) design the preschool home program activities(PHPA), (2) investigate the immediate efficacy of PHPA for children with DD, (3) investigate the long-term efficacy of PHPA for children with DD.The second year is to investigate the immediate efficacy of PHPA for children with DD.
Detailed description
A total of 36 children with DD, aged 2-6 years, were randomly assigned to the professional-based group (professional therapists delivering the PHPA, total n=13), parents-based group (parents executing the PHPA, n=12) and control group (health education only, n=11). Outcome measures included clinical assessments and subjective questionnaires. The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT). The subjective questionnaires were Chinese Child Developmental Inventory (CCDI), Assessment of preschool children's participation (APCP), TN0-AZL Preschool quality of life (TAPQOL) and parent stress index (PSI). Tests were administrated before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| professional-based group | Experimental | Behavioral: professional therapists delivering the PHPAprofessional therapists delivering the PHPA |
| parents-based group | Experimental | Behavioral: parents executing the PHPAparents executing the PHPA |
| control group | Active comparator | Behavioral: health educationhealth education only |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 0 to 6-years-old children
- clinical diagnosis of DD and other related disorders
Key exclusion criteria (2 listed)
- unstable physiological conditions
- progression or regression symptoms
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 |
|---|---|---|
| professional therapists delivering the PHPAAlso: PHPA(delivered by professional therapists)PHPA are delivered by professional therapists, which including gross motor, fine motor, cognition verbal, social interactions, activity of daily living(ADL). | Behavioural | professional-based group |
| parents executing the PHPAAlso: PHPA (executed by parents)PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL. | Behavioural | parents-based group |
| health educationhealth education of the children with DD. | Behavioural | control group |
Primary outcome
Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 months
Time frame: baseline, 8 weeks, 3 months, 6 months
The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT).
4 secondary outcomes
change from baseline in Chinese Child Developmental Inventory (CCDI) after 8 weeks intervention of PHPA at 6 months
Time frame: baseline, 8 weeks, 3 months, 6 months
change from baseline in Assessment of preschool children's participation(APCP) after 8 weeks intervention of PHPA at 6 months
Time frame: baseline, 8 weeks, 3 months, 6 months
change from baseline in TN0-AZL Preschool quality of life (TAPQOL) after 8 weeks intervention of PHPA at 6 months
Time frame: baseline, 8 weeks, 3 months, 6 months
change from baseline in parent stress index (PSI) after 8 weeks intervention of PHPA at 6 months
Time frame: baseline, 8 weeks, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
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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.
Chia-Ling Chen, MD,PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing professional therapists delivering the PHPA, parents executing the PHPA and health education in people with Developmental Delay, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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: finished, as of the sponsor's last update on 27 Feb 2015. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 months (time frame: baseline, 8 weeks, 3 months, 6 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 27 Feb 2015.