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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)

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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

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Dyslexia Behavioral: Climb Up ADHD and Dyslexia Program Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2007
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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



Primary Outcome Measures :
  1. Changes in ADHD scores using Vanderbilt [ Time Frame: Intervals of 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Improvement in speed and accuracy of reading samples for children with Dyslexia [ Time Frame: 6 to 12 monthly ]


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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012778


Locations
India
MDKV Schools
Najibabad, UP, India
Sponsors and Collaborators
Climb Up Kids
Investigators
Principal Investigator: Devendra Mehta, MBBS MSC MRCP Arnold Palmer Hospital for Children

Responsible Party: Devendra I Mehta, PI, Climb Up Kids
ClinicalTrials.gov Identifier: NCT01012778     History of Changes
Other Study ID Numbers: NAJMDKV2007
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Devendra I Mehta, Climb Up Kids:
Performance impairment
Yoga
Meditation
Peer mediated

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Dyslexia
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Learning Disorders