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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 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
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Dyslexia
 Behavioral: Climb Up ADHD and Dyslexia Program
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Climb Up Kids:

Primary Outcome Measures:
  • Changes in ADHD scores using Vanderbilt [ Time Frame: Intervals of 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: May 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Climb Up ADHD and Dyslexia Program
    Using a peer mediated multimodal intervention program for ADHD and Dyslexia
  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012778

Locations
India
MDKV Schools
Najibabad, UP, India
Sponsors and Collaborators
Climb Up Kids
  More Information

No publications provided

Responsible Party: Devendra I Mehta, MDKV Schools, Najibabad
ClinicalTrials.gov Identifier: NCT01012778     History of Changes
Other Study ID Numbers: NAJMDKV2007
Study First Received: November 5, 2009
Last Updated: November 12, 2009
Health Authority: India: Institutional Review Board

Keywords provided by 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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Learning Disorders

ClinicalTrials.gov processed this record on May 16, 2013