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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2009 by Climb Up Kids.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Climb Up Kids

ClinicalTrials.gov Identifier:

NCT01012778

First received: November 5, 2009

Last updated: November 12, 2009

Last verified: November 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	November 5, 2009
Last Updated Date	November 12, 2009
Start Date ^ICMJE	May 2007
Estimated Primary Completion Date	December 2009 (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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01012778 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ] Improvement in speed and accuracy of reading samples for children with Dyslexia [ Time Frame: 6 to 12 monthly ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 1 Phase 2
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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
Study Arm (s)	Not Provided
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	Active, not recruiting
Estimated Enrollment ^ICMJE	120
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2009 (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
Gender	Both
Ages	6 Years to 11 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	India

Administrative Information
NCT Number ^ICMJE	NCT01012778
Other Study ID Numbers ^ICMJE	NAJMDKV2007
Has Data Monitoring Committee	Not Provided
Responsible Party	Devendra I Mehta, MDKV Schools, Najibabad
Study Sponsor ^ICMJE	Climb Up Kids
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Climb Up Kids
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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