Revival Active Program for Adolescents With Depression

October 31, 2020 updated by: Revival Active

Impact of Revival Active Program on Adolescents With Depression: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Gyansanjeevani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Revival Active Program
Revival Program included supervised play group, twice a week followed by home practice.
Other: Revival Active Program
Program comprised of physical activities, group play, mind games, reasoning and discussion on sleeted topics, breath work and relaxation techniques, 60 minutes all together.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Changes from baseline depression at 8-week
Children Depression Inventory-II was used to assess depression level
Changes from baseline depression at 8-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Efficacy for Children
Time Frame: Changes from baseline self -efficacy at 8-week
Emotional, social and academic self efficacy was assessed using Self-Efficacy Questionnaire for Children
Changes from baseline self -efficacy at 8-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revival Active

Collaborators

NMP Medical Research Institute
L.E.A.D

Investigators

  • Study Chair: Sadhana Sharma, L.E.A.D
  • Principal Investigator: Sahil Signal, NMP Medical Research Institute, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2020

Primary Completion (Actual)

September 6, 2020

Study Completion (Actual)

September 18, 2020

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

October 31, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

October 31, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAP/002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe