AnxietyNCT04618341
A Clinical Study of Online Active Play Program With Adolescents
An observational study of Anxiety and Depression, run by Revival Active at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Anxiety, Depression
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Mar 2020to 28 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Child
Study population: Children who has attended online Revival Active Program (RAP) during COVID-19 lockdown
Who may be able to join
- 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
Who cannot join
- Children at normal levels of mental health screening
- Children who did not complete the intervention period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety, Depression
- Keywords
- Adolescents, Online Active Revival Program
- Medical subject headings
- Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Screen for Child Anxiety Related Disorders (SCARED) child version was used to assess anxiety levels.
Measured: Change from baseline anxiety at 6 weeks
Depression
Severity Measure for Depression child version was used to measure depression levels
Measured: Change from baseline depression at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start30 Mar 2020
- Primary completion30 Jun 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revival Active
- Sponsor type
- University, hospital or other
- Collaborators
- L.E.A.D, Aarogyam UK
- Responsible party
- Sponsor
- Investigators
- Rakesh Patel, Study director, Revival Active LimitedTejal Patel, Study director, Revival Active LimitedNagamani Krishnamurthy, Principal investigator, Aarogyam UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618341
- Sponsor's protocol ID
- RAP/003
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Online Active Play Program With Adolescents During COVID-19 Lockdown
- ClinicalTrials.gov ID
- NCT04618341
- Acronym / sponsor ID
- RAP/003
- Conditions
- Anxiety, Depression
- Keywords
- Adolescents, Online Active Revival Program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Revival ActiveUniversity, hospital or other
- Collaborators
- L.E.A.D, Aarogyam UK
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Children who has attended online Revival Active Program (RAP) during COVID-19 lockdown
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Children at normal levels of mental health screening
- Children who did not complete the intervention period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Depression
Time frame: Change from baseline depression at 6 weeks
Severity Measure for Depression child version was used to measure depression levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh Patel study director
Revival Active Limited
Tejal Patel study director
Revival Active Limited
Nagamani Krishnamurthy principal investigator
Aarogyam UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by Revival Active at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Change from baseline anxiety at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.