Child DevelopmentNCT03223688
Early Intervention for Developmental Delay
A study testing Day-Care early intervention program, OPD+SI intervention program and OPD intervention program in people with Child Development and Developmental Delay, run by Chang Gung Memorial Hospital.
Trial summary
This study aims to investigate the effectiveness of early intervention program in Department of Children and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital. The investigators assume that the frequency of early-intervention and degree of family involvement will be associate with the treatment outcome. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Developmental Delay, Early Intervention
- What is being tested?
- Day-Care early intervention program, OPD+SI intervention program and OPD intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2014to 11 May 2017
- 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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with Developmental Delay
- The caregivers are able to participate in the treatment program
Who cannot join
- Autism
- Cerebral palsy
About this study
Official title: Effectiveness of Adjunctive Sensory Integration Therapy for Children With Developmental Delay in an Early Intervention Program
This study aims to investigate the effectiveness of early intervention program in Department of Children and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital. The investigators assume that the frequency of early-intervention and degree of family involvement will be associate with the treatment outcome.
Read the detailed description
This prospective, non-randomized, open-label study is performed to assess the effects of adjunctive SI in the family-based treatment program of children with developmental delay (DD). The study subjects are children with DD who attended an early intervention (EI) program at Kaohsiung Chang Gung Memorial Hospital, which is the largest general hospital in the Southern Taiwan. Each participating child undergo a joint assessment by a pediatrician, a rehabilitation doctor, a child psychiatrist, a speech therapist, a physical therapist, an occupational therapist, and a social worker. Once the diagnosis of developmental delay is confirmed, the child will be scheduled for prescribed family-based early intervention in the same hospital. Children (between 2 to 4 years old) who attend the program will be enrolled in this study. Informed consent will be obtained from the children and their primary caregivers after they received a complete description of the study. The participants are categorized into three different groups based on their intervention method. The choice of intervention method will be according to the willingness and expedience of the children's caregivers.
- Conditions
- Child Development, Developmental Delay, Early Intervention
- Being tested
- Day-Care early intervention program, OPD+SI intervention program, OPD intervention program
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day-Care early intervention programBehavioural
The daily treatment session had eight children along with their major caregivers. The treatment was conducted by two experienced occupational therapists (OT), and each session lasted for four hours in the week-day morning with a 10-minute break. The goal of the sessions was to enhance children's development through cognitive training, behavioral modification plan and parenting skill training.
OPD+SI intervention programBehavioural
Also called Adjunctive Sensory Integration (SI) Therapy
The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Adjunctive SI therapy was also performed by said OT for improving children's sensory motor development in an additional hour.
OPD intervention programBehavioural
The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training.
| Study group | Role | What they receive |
|---|---|---|
| Day-Care early intervention program | Experimental | The daily treatment session had eight children along with their major caregivers. The treatment was conducted by two experienced occupational therapists (OT), and each session lasted for four hours in the week-day morning with a 10-minute break. The goal of the sessions was to enhance children's development through cognitive training, behavioral modification plan and parenting skill training. Said therapists assisted the caregivers in improving their nurturing and parenting skills with their children, as well as their techniques with regards to influencing them. Receives: Behavioral: Day-Care early intervention program |
| OPD+SI intervention program | Experimental | The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Adjunctive SI therapy was also performed by said OT for improving children's sensory motor development in an additional hour. Receives: Behavioral: OPD+SI intervention program |
| OPD intervention program | Active comparator | The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Receives: Behavioral: OPD intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of children's development
Mullen Scales of Early Learning
Measured: Assessment will be performed at baseline and 6-month after the baseline
Secondary outcomes (2)
Changes of caregivers' life quality
The World Health Organization Quality of Life- BREF (WHOQOL-BREF)
Measured: Assessment will be performed at baseline and 6-month after the baseline
Changes of caregivers' parenting stress
The Parenting Stress Index-Short Form (PSI-SF)
Measured: Assessment will be performed at baseline and 6-month after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start12 May 2014
- Primary completion11 May 2017
- Study completion11 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Liang-Jen, Chang Gung Memorial Hospital
- Investigators
- Liang-Jen Wang, Principal investigator, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223688
- Sponsor's protocol ID
- 105-1742C1
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adjunctive Sensory Integration Therapy for Children With Developmental Delay in an Early Intervention Program
- ClinicalTrials.gov ID
- NCT03223688
- Acronym / sponsor ID
- 105-1742C1
- Conditions
- Child Development, Developmental Delay, Early Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 May 2014 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 21 Jul 2017 (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.
This study aims to investigate the effectiveness of early intervention program in Department of Children and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital. The investigators assume that the frequency of early-intervention and degree of family involvement will be associate with the treatment outcome.
Detailed description
This prospective, non-randomized, open-label study is performed to assess the effects of adjunctive SI in the family-based treatment program of children with developmental delay (DD). The study subjects are children with DD who attended an early intervention (EI) program at Kaohsiung Chang Gung Memorial Hospital, which is the largest general hospital in the Southern Taiwan. Each participating child undergo a joint assessment by a pediatrician, a rehabilitation doctor, a child psychiatrist, a speech therapist, a physical therapist, an occupational therapist, and a social worker. Once the diagnosis of developmental delay is confirmed, the child will be scheduled for prescribed family-based early intervention in the same hospital. Children (between 2 to 4 years old) who attend the program will be enrolled in this study. Informed consent will be obtained from the children and their primary caregivers after they received a complete description of the study. The participants are categorized into three different groups based on their intervention method. The choice of intervention method will be according to the willingness and expedience of the children's caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Day-Care early intervention program | Experimental | Behavioral: Day-Care early intervention programThe daily treatment session had eight children along with their major caregivers. The treatment was conducted by two experienced occupational therapists (OT), and each session lasted for four hours in the week-day morning with a 10-minute break. The goal of the sessions was to enhance children's development through cognitive training, behavioral modification plan and parenting skill training. Said therapists assisted the caregivers in improving their nurturing and parenting skills with their children, as well as their techniques with regards to influencing them. |
| OPD+SI intervention program | Experimental | Behavioral: OPD+SI intervention programThe treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Adjunctive SI therapy was also performed by said OT for improving children's sensory motor development in an additional hour. |
| OPD intervention program | Active comparator | Behavioral: OPD intervention programThe treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with Developmental Delay
- The caregivers are able to participate in the treatment program
Key exclusion criteria (2 listed)
- Autism
- Cerebral palsy
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 |
|---|---|---|
| Day-Care early intervention programThe daily treatment session had eight children along with their major caregivers. The treatment was conducted by two experienced occupational therapists (OT), and each session lasted for four hours in the week-day morning with a 10-minute break. The goal of the sessions was to enhance children's development through cognitive training, behavioral modification plan and parenting skill training. | Behavioural | Day-Care early intervention program |
| OPD+SI intervention programAlso: Adjunctive Sensory Integration (SI) TherapyThe treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Adjunctive SI therapy was also performed by said OT for improving children's sensory motor development in an additional hour. | Behavioural | OPD+SI intervention program |
| OPD intervention programThe treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. | Behavioural | OPD intervention program |
Primary outcome
Changes of children's development
Time frame: Assessment will be performed at baseline and 6-month after the baseline
Mullen Scales of Early Learning
2 secondary outcomes
Changes of caregivers' life quality
Time frame: Assessment will be performed at baseline and 6-month after the baseline
Changes of caregivers' parenting stress
Time frame: Assessment will be performed at baseline and 6-month after the baseline
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 21 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Liang-Jen Wang principal investigator
Chang Gung Memorial Hospital, Kaohsiung, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing Day-Care early intervention program, OPD+SI intervention program and OPD intervention program in people with Child Development and Developmental Delay, run by Chang Gung Memorial Hospital.
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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes of children's development (time frame: Assessment will be performed at baseline and 6-month after the baseline). 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 21 Jul 2017; AzTrials last refreshed its copy on 27 Oct 2026.