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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01012778
Other study ID # NAJMDKV2007
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received November 5, 2009
Last updated August 3, 2015
Start date May 2007
Est. completion date August 2015

Study information

Verified date August 2015
Source Climb Up Kids
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 11 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Dyslexia
  • Hyperkinesis

Intervention

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

Locations

Country Name City State
India MDKV Schools Najibabad UP

Sponsors (1)

Lead Sponsor Collaborator
Climb Up Kids

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in ADHD scores using Vanderbilt Intervals of 6 months No
Secondary Improvement in self-care as assessed by improvement in dental Decayed, Missing and Filled Teeth (DMFT) scores 6 to 12 month interval changes No
Secondary Improvement in speed and accuracy of reading samples for children with Dyslexia 6 to 12 monthly No
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