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Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India (ClimbUp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01012778
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Devendra I Mehta, Climb Up Kids

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 13, 2009
Last Update Posted Date August 4, 2015
Study Start Date  ICMJE May 2007
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2009)
Changes in ADHD scores using Vanderbilt [ Time Frame: Intervals of 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2009)
  • 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 ]
  • Improvement in speed and accuracy of reading samples for children with Dyslexia [ Time Frame: 6 to 12 monthly ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Attention Deficit Hyperactivity Disorder
  • Dyslexia
Intervention  ICMJE Behavioral: Climb Up ADHD and Dyslexia Program
Using a peer mediated multimodal intervention program for ADHD and Dyslexia use Yoga, Meditation, Play therapy administered by (trained) high school volunteers
Study Arms  ICMJE 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

Intervention: Behavioral: Climb Up ADHD and Dyslexia Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2015)
76
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2009)
120
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01012778
Other Study ID Numbers  ICMJE NAJMDKV2007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Devendra I Mehta, Climb Up Kids
Study Sponsor  ICMJE Climb Up Kids
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Devendra Mehta, MBBS MSC MRCP Arnold Palmer Hospital for Children
PRS Account Climb Up Kids
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP