NCT04618562

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable depression

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 28, 2020

Last Update Submit

October 31, 2020

Conditions

Depression

Keywords

AdolescentRevival Active Program

Outcome Measures

Primary Outcomes (1)

  • Depression

    Children Depression Inventory-II was used to assess depression level

    Changes from baseline depression at 8-week

Secondary Outcomes (1)

  • Self-Efficacy for Children

    Changes from baseline self -efficacy at 8-week

Study Arms (1)

Revival Active Program

EXPERIMENTAL

Revival Program included supervised play group, twice a week followed by home practice.

Other: Revival Active Program

Interventions

Revival Active ProgramOTHER

Program comprised of physical activities, group play, mind games, reasoning and discussion on sleeted topics, breath work and relaxation techniques, 60 minutes all together.

Revival Active Program

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with depression as per the DSM IV-TR criteria
  • Parents willing to give written informed consent

You may not qualify if:

  • Physical limitation for active sports
  • Co-morbid mental health diagnosis
  • high risk of self harm/ suicide
  • history of self harm or harming someone else

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyansanjeevani

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Rakesh Patel

    Revival Active Limited

    STUDY DIRECTOR

  • Tejal Patel

    Revival Active Limited

    STUDY DIRECTOR

  • Sadhana Sharma

    L.E.A.D

    STUDY CHAIR

  • Sahil Signal

    NMP Medical Research Institute, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 6, 2020

Study Start

March 3, 2020

Primary Completion

September 6, 2020

Study Completion

September 18, 2020

Last Updated

November 6, 2020

Record last verified: 2020-10

Locations

IN(1)