A Clinical Study of Online Active Play Program With Adolescents

October 31, 2020 updated by: Revival Active

A Clinical Study of Online Active Play Program With Adolescents During COVID-19 Lockdown

To assess the efficacy of an online, active play program (Revival Active Program) in reducing the symptoms of anxiety and depression in community-based adolescents,, a retrospective community based participatory research was conducted with 32 adolescents aged between 11-17 years old.

Program was conducted during Covid-19 lockdown from March 2020 to June 2020 to support children and families in isolation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

32

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

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom
        • Revival Active

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

11 years to 17 years (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children who has attended online Revival Active Program (RAP) during COVID-19 lockdown

Description

Inclusion Criteria:

  • Children at the online program for whole duration
  • indicating a symptom level of, at minimum, above mean on anxiety and/or depression on self-report measures
  • Parental consent before stating the program

Exclusion Criteria:

  • Children at normal levels of mental health screening
  • Children who did not complete the intervention period

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Change from baseline anxiety at 6 weeks
Screen for Child Anxiety Related Disorders (SCARED) child version was used to assess anxiety levels.
Change from baseline anxiety at 6 weeks
Depression
Time Frame: Change from baseline depression at 6 weeks
Severity Measure for Depression child version was used to measure depression levels
Change from baseline depression at 6 weeks

Collaborators and Investigators

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

Sponsor

Revival Active

Collaborators

Aarogyam UK
L.E.A.D

Investigators

  • Principal Investigator: Nagamani Krishnamurthy, Aarogyam UK

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 30, 2020

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

July 28, 2020

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

October 31, 2020

First Posted (ACTUAL)

November 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 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/003

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.

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