Mental HealthNCT06693713
Sanctuary Youth Series Randomized Control Trial
A study testing Mental Health Youth Series in people with Mental Health and Mental Health Help-Seeking, run by Sanctuary Mental Health Ministries at 1 site in United States.
Trial summary
Sanctuary Mental Health Ministries designed an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. The intervention package includes a facilitation guide and a guide for parents and caregivers. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Mental Health Help-Seeking, Mental Health Literacy
- What is being tested?
- Mental Health Youth Series
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youth between the ages of 11-18 attending a youth group that has been recruited to the study.
Who cannot join
- Youth outside of the age range that are not attending a youth group recruited to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Excellence in Giving Insights
Colorado Springs, Colorado, 80906
Ashley Williams, Master, 240-997-8685, awilliams@excellenceingiving.com
Kate Williams, Masters, 412-841-5833, kwilliams@excellenceingiving.com
About this study
Official title: The Youth Series Sanctuary Mental Health Ministries Randomized Control Trial
Sanctuary Mental Health Ministries designed an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. The intervention package includes a facilitation guide and a guide for parents and caregivers. The program is intended to be conducted by an experienced facilitator, although there is no specific training provided for facilitators outside of the facilitation guide. The facilitator would lead groups of 11-15 year olds by leading games, showing the films, and facilitating discussion. The series is freely available on Sanctuary's website; individuals can access the material by creating an account, logging in, and downloading the course content. This RCT is to evaluate the effectiveness of the Youth Series course on improving youth's mental health literacy, knowledge, and attitudes towards help-seeking.
Read the detailed description
Churches will be recruited to the study based on social media sites and through Sanctuary's newsletter distribution lists. Churches who agree to participate in the study will be randomized to one of two groups, the Pilot Group that receives the 8-week series, and the Comparison Group, that does not receive the series. Both groups will be asked to complete a baseline survey and then a follow-up (end line) survey 8-weeks later. The results will be scored and compared between the two groups.
- Being tested
- Mental Health Youth Series
- Keywords
- Mental Health, Youth
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Youth SeriesOther
The Mental Health Youth Series is an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. The intervention package includes a facilitation guide and a guide for parents and caregivers. The program is intended to be conducted by an experienced facilitator, although there is no specific training provided for facilitators outside of the facilitation guide.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Group | Experimental | This group will receive an 8 week course on mental health knowledge. The series has been designed as an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. Receives: Other: Mental Health Youth Series |
| Comparison Group | No intervention | This group will not receive any mental health information, but will continue using their normal youth group material as planned. They will participate in the baseline and end line surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Knowledge
Participants will answer mental health knowledge scores, either correct or incorrect.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start18 Nov 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanctuary Mental Health Ministries
- Sponsor type
- University, hospital or other
- Collaborators
- Excellence in Giving Insights
- Responsible party
- Principal investigator, Kate Williams, Sanctuary Mental Health Ministries
- Investigators
- Kate Williams, Masters, Principal investigator, Excellence in Giving InsightsAshley Williams, Masters, Study director, Excellence in Giving InsightsLincoln Lau, PhD, Study chair, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693713
- Sponsor's protocol ID
- Pending
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to publish this data in the International Committee of Medical Journal (ICMJ)
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Youth Series Sanctuary Mental Health Ministries Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06693713
- Acronym / sponsor ID
- Pending
- Keywords
- Mental Health, Youth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sanctuary Mental Health MinistriesUniversity, hospital or other
- Collaborators
- Excellence in Giving Insights
- Study start
- 18 Nov 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 18 Nov 2024 (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.
Sanctuary Mental Health Ministries designed an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. The intervention package includes a facilitation guide and a guide for parents and caregivers. The program is intended to be conducted by an experienced facilitator, although there is no specific training provided for facilitators outside of the facilitation guide. The facilitator would lead groups of 11-15 year olds by leading games, showing the films, and facilitating discussion. The series is freely available on Sanctuary's website; individuals can access the material by creating an account, logging in, and downloading the course content. This RCT is to evaluate the effectiveness of the Youth Series course on improving youth's mental health literacy, knowledge, and attitudes towards help-seeking.
Detailed description
Churches will be recruited to the study based on social media sites and through Sanctuary's newsletter distribution lists. Churches who agree to participate in the study will be randomized to one of two groups, the Pilot Group that receives the 8-week series, and the Comparison Group, that does not receive the series. Both groups will be asked to complete a baseline survey and then a follow-up (end line) survey 8-weeks later. The results will be scored and compared between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot Group | Experimental | Other: Mental Health Youth SeriesThis group will receive an 8 week course on mental health knowledge. The series has been designed as an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. |
| Comparison Group | No intervention | –This group will not receive any mental health information, but will continue using their normal youth group material as planned. They will participate in the baseline and end line surveys. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Youth between the ages of 11-18 attending a youth group that has been recruited to the study.
Key exclusion criteria (1 listed)
- Youth outside of the age range that are not attending a youth group recruited to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Health Youth SeriesThe Mental Health Youth Series is an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. The intervention package includes a facilitation guide and a guide for parents and caregivers. The program is intended to be conducted by an experienced facilitator, although there is no specific training provided for facilitators outside of the facilitation guide. | Other | Pilot Group |
Primary outcome
Mental Health Knowledge
Time frame: 8 weeks
Participants will answer mental health knowledge scores, either correct or incorrect.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No. We do not plan to publish this data in the International Committee of Medical Journal (ICMJ)
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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.
Kate Williams, Masters principal investigator
Excellence in Giving Insights
Ashley Williams, Masters study director
Excellence in Giving Insights
Lincoln Lau, PhD study chair
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health Youth Series in people with Mental Health and Mental Health Help-Seeking, run by Sanctuary Mental Health Ministries at 1 site in United States.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 18 Nov 2024. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley R Williams, Masters (240-997-8685, AWilliams@excellenceingiving.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Knowledge (time frame: 8 weeks). 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 18 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.