Attention Deficit Hyperactivity DisorderPhase 1/2ClimbUpNCT01012778
Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India
A Phase 1/2 study testing Climb Up ADHD and Dyslexia Program in people with Attention Deficit Hyperactivity Disorder and Dyslexia, run by Climb Up Kids at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Dyslexia
- What is being tested?
- Climb Up ADHD and Dyslexia Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIndia
- Study dates
- May 2007to Aug 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children between 6 and 11 years attending MDKV public school in Najibabad, UP who had assessment performed for ADHD or Dyslexia
Who cannot join
- Children who were not enrolled by the parents
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Attention Deficit Hyperactivity Disorder, Dyslexia
- Being tested
- Climb Up ADHD and Dyslexia Program
- Keywords
- Performance impairment, Yoga, Meditation, Peer mediated
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Climb Up ADHD and Dyslexia ProgramBehavioural
Using a peer mediated multimodal intervention program for ADHD and Dyslexia use Yoga, Meditation, Play therapy administered by (trained) high school volunteers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Climb Up ADHD and Dyslexia Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ADHD scores using Vanderbilt
Measured: Intervals of 6 months
Secondary outcomes (2)
Improvement in self-care as assessed by improvement in dental Decayed, Missing and Filled Teeth (DMFT) scores
Measured: 6 to 12 month interval changes
Improvement in speed and accuracy of reading samples for children with Dyslexia
Measured: 6 to 12 monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startMay 2007
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Climb Up Kids
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devendra I Mehta, Climb Up Kids
- Investigators
- Devendra Mehta, MBBS MSC MRCP, Principal investigator, Arnold Palmer Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012778
- Sponsor's protocol ID
- NAJMDKV2007
- Acronym
- ClimbUp
- Status last verified
- Aug 2015
- First submitted
- 5 Nov 2009
- Last updated
- 4 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01012778
- Acronym / sponsor ID
- ClimbUp / NAJMDKV2007
- Conditions
- Attention Deficit Hyperactivity Disorder, Dyslexia
- Keywords
- Performance impairment, Yoga, Meditation, Peer mediated
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Climb Up KidsUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Climbup ADHD and Dyslexia Program | Experimental | Behavioral: Climb Up ADHD and Dyslexia ProgramOpen 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 |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children between 6 and 11 years attending MDKV public school in Najibabad, UP who had assessment performed for ADHD or Dyslexia
Key exclusion criteria (1 listed)
- Children who were not enrolled by the parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Climb Up ADHD and Dyslexia ProgramUsing a peer mediated multimodal intervention program for ADHD and Dyslexia use Yoga, Meditation, Play therapy administered by (trained) high school volunteers | Behavioural | Climbup ADHD and Dyslexia Program |
Primary outcome
Changes in ADHD scores using Vanderbilt
Time frame: Intervals of 6 months
2 secondary outcomes
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
Improvement in speed and accuracy of reading samples for children with Dyslexia
Time frame: 6 to 12 monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devendra Mehta, MBBS MSC MRCP principal investigator
Arnold Palmer Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Climb Up ADHD and Dyslexia Program in people with Attention Deficit Hyperactivity Disorder and Dyslexia, run by Climb Up Kids at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ADHD scores using Vanderbilt (time frame: Intervals of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015; AzTrials last refreshed its copy on 31 Oct 2026.