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
-
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Leicestershire
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Leicester, Leicestershire, United Kingdom
- Revival Active
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-
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
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.