Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India (ClimbUp)
Primary Purpose
Attention Deficit Hyperactivity Disorder, Dyslexia
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Climb Up ADHD and Dyslexia Program
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Performance impairment, Yoga, Meditation, Peer mediated
Eligibility Criteria
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
Sites / Locations
- MDKV Schools
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Climbup ADHD and Dyslexia Program
Arm Description
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
Outcomes
Primary Outcome Measures
Changes in ADHD scores using Vanderbilt
Secondary Outcome Measures
Improvement in self-care as assessed by improvement in dental Decayed, Missing and Filled Teeth (DMFT) scores
Improvement in speed and accuracy of reading samples for children with Dyslexia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01012778
Brief Title
Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India
Acronym
ClimbUp
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Climb Up Kids
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Dyslexia
Keywords
Performance impairment, Yoga, Meditation, Peer mediated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Climbup ADHD and Dyslexia Program
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Climb Up ADHD and Dyslexia Program
Intervention Description
Using a peer mediated multimodal intervention program for ADHD and Dyslexia use Yoga, Meditation, Play therapy administered by (trained) high school volunteers
Primary Outcome Measure Information:
Title
Changes in ADHD scores using Vanderbilt
Time Frame
Intervals of 6 months
Secondary Outcome Measure Information:
Title
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
Title
Improvement in speed and accuracy of reading samples for children with Dyslexia
Time Frame
6 to 12 monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devendra Mehta, MBBS MSC MRCP
Organizational Affiliation
Arnold Palmer Hospital for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDKV Schools
City
Najibabad
State/Province
UP
Country
India
12. IPD Sharing Statement
Learn more about this trial
Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India
We'll reach out to this number within 24 hrs