- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01012778
Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India (ClimbUp)
August 3, 2015 updated by: Devendra I Mehta, Climb Up Kids
Implementation of a Multimodal Program Including Yoga and Meditation as Well as Play Therapy for ADHD and Dyslexia in a Public School in Najibabad, India
A multimodal intervention was rolled out at a large public school in Najibabad, Uttar Pradesh (UP).
The program identified elementary school children with ADHD and Dyslexia using standard screening of all children who had performance impairment in at least one domain of the Vanderbilt questionnaire.
The program consisted of play therapy, physical exercise, yoga and meditation.
The program was established by High school volunteers from The US and UK over 6 weeks.
Once implemented during the morning of school, high school volunteers from the school were trained to continue the program.
Vanderbilt questionnaires were completed at intervals to allow follow up.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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UP
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Najibabad, UP, India
- MDKV Schools
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 11 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All children between 6 and 11 years attending MDKV public school in Najibabad, UP who had assessment performed for ADHD or Dyslexia
Exclusion Criteria:
- Children who were not enrolled by the parents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Climbup ADHD and Dyslexia Program
Open label - intervention with pre and post parameters collected Intervention: Yoga, Meditation, Play therapy for children with ADHD and Dyslexia twice a week in classroom with 6 week and 12 month, primary outcomes in terms of Vanderbilt ADHD scores |
Using a peer mediated multimodal intervention program for ADHD and Dyslexia use Yoga, Meditation, Play therapy administered by (trained) high school volunteers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in ADHD scores using Vanderbilt
Time Frame: Intervals of 6 months
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Intervals of 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in self-care as assessed by improvement in dental Decayed, Missing and Filled Teeth (DMFT) scores
Time Frame: 6 to 12 month interval changes
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6 to 12 month interval changes
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Improvement in speed and accuracy of reading samples for children with Dyslexia
Time Frame: 6 to 12 monthly
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6 to 12 monthly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Devendra Mehta, MBBS MSC MRCP, Arnold Palmer Hospital for Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (ACTUAL)
August 1, 2015
Study Completion (ACTUAL)
August 1, 2015
Study Registration Dates
First Submitted
November 5, 2009
First Submitted That Met QC Criteria
November 12, 2009
First Posted (ESTIMATE)
November 13, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 4, 2015
Last Update Submitted That Met QC Criteria
August 3, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Language Disorders
- Communication Disorders
- Learning Disabilities
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Dyslexia
Other Study ID Numbers
- NAJMDKV2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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