A Clinical Study of Online Active Play Program With Adole... | NCT04618341

Studies
A Clinical Study of Online Active Play Program With Adolescents

NCT04618341

Sponsor

Revival Active

Status

Completed

Last Update Posted

Nov 5, 2020Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Anxiety
Depression

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2020Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jul 28, 2020Actual

First Submitted Date

Oct 28, 2020

First Submission Date that Met QC Criteria

Oct 31, 2020

First Posted Date

Nov 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2020

Last Update Posted Date

Nov 5, 2020Actual

Name	Class
L.E.A.D	UNKNOWN
Aarogyam UK	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rakesh Patel	Revival Active Limited	Study Director
Tejal Patel	Revival Active Limited	Study Director
Nagamani Krishnamurthy	Aarogyam UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Revival Active		Leicester	Leicestershire		United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D003863	Depression

Ancestor Terms

ID	Term
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided