NCT01012778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

8.3 years

First QC Date

November 5, 2009

Last Update Submit

August 3, 2015

Conditions

Keywords

Performance impairmentYogaMeditationPeer mediated

Outcome Measures

Primary Outcomes (1)

  • Changes in ADHD scores using Vanderbilt

    Intervals of 6 months

Secondary Outcomes (2)

  • Improvement in self-care as assessed by improvement in dental Decayed, Missing and Filled Teeth (DMFT) scores

    6 to 12 month interval changes

  • Improvement in speed and accuracy of reading samples for children with Dyslexia

    6 to 12 monthly

Study Arms (1)

Climbup ADHD and Dyslexia Program

EXPERIMENTAL

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

Interventions

Using a peer mediated multimodal intervention program for ADHD and Dyslexia use Yoga, Meditation, Play therapy administered by (trained) high school volunteers

Climbup ADHD and Dyslexia Program

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All children between 6 and 11 years attending MDKV public school in Najibabad, UP who had assessment performed for ADHD or Dyslexia

You may not qualify if:

  • Children who were not enrolled by the parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDKV Schools

Najībābād, Uttar Pradesh, India

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDyslexia

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Devendra Mehta, MBBS MSC MRCP

    Arnold Palmer Hospital for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 13, 2009

Study Start

May 1, 2007

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations