- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06693713
Sanctuary Youth Series Randomized Control Trial
November 14, 2024 updated by: Kate Williams, Sanctuary Mental Health Ministries
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ashley R Williams, Masters
- Phone Number: 240-997-8685
- Email: AWilliams@excellenceingiving.com
Study Contact Backup
- Name: Kate Williams-Whitley, Masters
- Phone Number: 412-841-5833
- Email: kwilliams@excellenceingiving.com
Study Locations
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80906
- Excellence in Giving Insights
-
Contact:
- Ashley Williams, Master
- Phone Number: 240-997-8685
- Email: awilliams@excellenceingiving.com
-
Contact:
- Kate Williams, Masters
- Phone Number: 412-841-5833
- Email: kwilliams@excellenceingiving.com
-
Principal Investigator:
- Kate Williams, Masters
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Youth between the ages of 11-18 attending a youth group that has been recruited to the study.
Exclusion Criteria:
- Youth outside of the age range that are not attending a youth group recruited to the study.
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilot Group
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.
|
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.
|
|
No Intervention: Comparison Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental Health Knowledge
Time Frame: 8 weeks
|
Participants will answer mental health knowledge scores, either correct or incorrect.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kate Williams, Masters, Excellence in Giving Insights
- Study Director: Ashley Williams, Masters, Excellence in Giving Insights
- Study Chair: Lincoln Lau, PhD, University of Toronto
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 (Estimated)
November 18, 2024
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
November 14, 2024
First Submitted That Met QC Criteria
November 14, 2024
First Posted (Estimated)
November 18, 2024
Study Record Updates
Last Update Posted (Estimated)
November 18, 2024
Last Update Submitted That Met QC Criteria
November 14, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pending (Clinical Research Information Service)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We do not plan to publish this data in the International Committee of Medical Journal (ICMJ)
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.
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