Back to resultsRevival Active Program for Adolescents With Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Revival Active Program
Sponsored by
About this trial
This is an interventional supportive care trial for Depression focused on measuring Adolescent, Revival Active Program
Eligibility Criteria
Inclusion Criteria:
- Children diagnosed with depression as per the DSM IV-TR criteria
- Parents willing to give written informed consent
Exclusion Criteria:
- Physical limitation for active sports
- Co-morbid mental health diagnosis
- high risk of self harm/ suicide
- history of self harm or harming someone else
Sites / Locations
- Gyansanjeevani
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Revival Active Program
Arm Description
Revival Program included supervised play group, twice a week followed by home practice.
Outcomes
Primary Outcome Measures
Depression
Children Depression Inventory-II was used to assess depression level
Secondary Outcome Measures
Self-Efficacy for Children
Emotional, social and academic self efficacy was assessed using Self-Efficacy Questionnaire for Children
Full Information
NCT ID
NCT04618562
First Posted
October 28, 2020
Last Updated
October 31, 2020
Sponsor
Revival Active
Collaborators
L.E.A.D, NMP Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04618562
Brief Title
Revival Active Program for Adolescents With Depression
Official Title
Impact of Revival Active Program on Adolescents With Depression: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
September 6, 2020 (Actual)
Study Completion Date
September 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revival Active
Collaborators
L.E.A.D, NMP Medical Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Active play and sports has shown to be effective intervention in managing depression. Extending the support with Mind body therapy, Revival Active Program was designed as an early intervention for adolescents.
To measure the efficacy and feasibility of the community based revival active play intervention for adolescent depression, present pilot study was undertaken.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Adolescent, Revival Active Program
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Revival Active Program
Arm Type
Experimental
Arm Description
Revival Program included supervised play group, twice a week followed by home practice.
Intervention Type
Other
Intervention Name(s)
Revival Active Program
Intervention Description
Program comprised of physical activities, group play, mind games, reasoning and discussion on sleeted topics, breath work and relaxation techniques, 60 minutes all together.
Primary Outcome Measure Information:
Title
Depression
Description
Children Depression Inventory-II was used to assess depression level
Time Frame
Changes from baseline depression at 8-week
Secondary Outcome Measure Information:
Title
Self-Efficacy for Children
Description
Emotional, social and academic self efficacy was assessed using Self-Efficacy Questionnaire for Children
Time Frame
Changes from baseline self -efficacy at 8-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children diagnosed with depression as per the DSM IV-TR criteria
Parents willing to give written informed consent
Exclusion Criteria:
Physical limitation for active sports
Co-morbid mental health diagnosis
high risk of self harm/ suicide
history of self harm or harming someone else
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Patel
Organizational Affiliation
Revival Active Limited
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tejal Patel
Organizational Affiliation
Revival Active Limited
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sadhana Sharma
Organizational Affiliation
L.E.A.D
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sahil Signal
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gyansanjeevani
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Revival Active Program for Adolescents With Depression
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