NCT04618341

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Last Updated

November 5, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 28, 2020

Last Update Submit

October 31, 2020

Conditions

AnxietyDepression

Keywords

AdolescentsOnline Active Revival Program

Outcome Measures

Primary Outcomes (2)

  • Anxiety

    Screen for Child Anxiety Related Disorders (SCARED) child version was used to assess anxiety levels.

    Change from baseline anxiety at 6 weeks

  • Depression

    Severity Measure for Depression child version was used to measure depression levels

    Change from baseline depression at 6 weeks

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Revival Active

Leicester, Leicestershire, United Kingdom

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Rakesh Patel

    Revival Active Limited

    STUDY DIRECTOR

  • Tejal Patel

    Revival Active Limited

    STUDY DIRECTOR

  • Nagamani Krishnamurthy

    Aarogyam UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 5, 2020

Study Start

March 30, 2020

Primary Completion

June 30, 2020

Study Completion

July 28, 2020

Last Updated

November 5, 2020

Record last verified: 2020-10

Locations

GB(1)