Mental Health Program for Youth

Overseen By Kate Williams-Whitley, Masters

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Sanctuary Mental Health Ministries

Disqualifiers: Age outside 11-18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an eight-week mental health program for youth aged 11-15. The program uses games, short films, and discussions to help young people understand mental health and learn how to seek help if needed. Participants will be divided into two groups: one will take the course, called the Youth Series, while the other will continue with their regular youth group activities. The trial aims to determine if the program improves mental health knowledge and attitudes. Youth already part of a participating youth group are well-suited for this trial. As an unphased trial, this study offers a unique opportunity for youth to contribute to important research that could enhance mental health education.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this program is safe for youth?

Research shows that programs like the Youth Series, which focus on teaching about mental health, are generally safe for young people. This program incorporates games, films, and discussions, similar to school activities. Without medicines or physical treatments, the risk of unwanted side effects is lower.

The Youth Series aims to enhance kids' understanding of mental health. Although specific data on this program's safety is not available, educational programs about mental health typically yield positive results without causing harm. The goal is to improve mental health understanding and encourage seeking help in a supportive and safe manner.

The trial is labeled "Not Applicable" in terms of phases, indicating it doesn't involve experimental drugs or risky procedures. This usually means fewer safety concerns compared to trials with such components. Prospective participants are encouraged to ask questions and share any concerns before joining to ensure comfort with the program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Youth Series mental health program because it takes a fresh and engaging approach to mental health education for young people. Unlike standard options that might involve therapy sessions or medication, this program uses interactive methods like games, short films, and discussions to make learning about mental health and faith more relatable and fun for kids aged 11-15. By integrating these activities, the program aims to not only inform but also actively involve youth, potentially making mental health topics less intimidating and more accessible.

What evidence suggests that the Youth Series program is effective for improving mental health literacy in youth?

Research has shown that school-based mental health programs like the Youth Series, which participants in this trial's Pilot Group will receive, can effectively improve young people's understanding and attitudes about mental health. In a study with 473 students from four schools, participants in similar programs gained more knowledge about mental health topics. Another review found that these programs can help lower the risk of developing mental health issues by increasing awareness and encouraging positive attitudes. These programs often include fun activities, making learning more engaging for young people. Overall, evidence suggests that the Youth Series can positively impact mental health knowledge and encourage young people to seek help when needed. ^{6 7 8 9 10}

Who Is on the Research Team?

Lincoln Lau, PhD

Principal Investigator

University of Toronto

Kate Williams, Masters

Principal Investigator

Excellence in Giving Insights

Ashley Williams, Masters

Principal Investigator

Excellence in Giving Insights

Are You a Good Fit for This Trial?

This trial is for young people aged 11-18 who are part of a youth group that's participating in the study. It's not open to those outside this age range or not in a recruited group.

Exclusion Criteria

Youth outside of the age range that are not attending a youth group recruited to the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the Pilot Group receive an 8-week program on mental health knowledge using games, short films, and discussions

8 weeks

Follow-up

Participants are monitored for changes in mental health knowledge and attitudes towards help-seeking

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Youth Series

Trial Overview

The Sanctuary Youth Series, an eight-week mental health program with games, films, and discussions designed for youths to improve their understanding and attitudes towards mental health and seeking help.

How Is the Trial Designed?

Group I: Pilot Group Experimental Treatment 1 Intervention

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.

Group II: Comparison Group Active Control 1 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 Is Running the Clinical Trial?

Sanctuary Mental Health Ministries

Lead Sponsor

Trials

1

Recruited

2,000+

Excellence in Giving Insights

Collaborator

Trials

1

Recruited

2,000+

Published Research Related to This Trial

The study evaluated nursing and multidisciplinary interventions in a Youth Inpatient Unit in Christchurch, New Zealand, focusing on their effectiveness in improving outcomes for adolescents, as measured by the Health of the Nation Outcome Scales for Children and Adolescents.

Findings suggest that while most interventions were used similarly across different diagnoses, stress management and problem-solving education were particularly beneficial for patients with mixed affective disorders, highlighting the importance of targeted interventions in adolescent psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination of frequent nursing interventions and outcomes in an adolescent psychiatric inpatient unit. Bobier, C., Dowell, J., Swadi, H.[2019]

The nurse-led mind caring youth activist program in a rural Thai school positively impacted the mental health of participating students, with 42 youth activists reporting improvements in their well-being.

Teachers also showed a more positive attitude towards addressing students' mental health needs, while nursing students gained confidence and self-awareness through their involvement, indicating the program's effectiveness in fostering a supportive school environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early findings of a nurse-led youth activist program in mind caring. Aekwarangkoon, S., LeClair, J., Oakley, LD.[2023]

A study of 3098 children and adolescents receiving treatment at Child and Youth Mental Health Services in Brisbane revealed that anxiety and mood disorders were the most prevalent, with many patients experiencing multiple disorders and psychosocial stressors.

While there was a significant improvement in mental health symptoms during treatment, with effect sizes around 0.9, about 50% of the participants still had clinical-level symptoms at the end, indicating a need for enhanced treatment strategies to further reduce these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and treatment outcomes of children and adolescents accessing treatment in Child and Youth Mental Health Services. Lu, ZQ., de Geus, H., Roest, S., et al.[2023]

A review of pediatric psychopharmacology trials over the past 10 years revealed that only 11.8% utilized a data and safety monitoring board (DSMB), indicating a significant gap in safety monitoring practices for this vulnerable population.

Most trials relied on basic safety elicitation methods, such as laboratory tests and vital signs, with only 6% depending solely on spontaneous reporting of adverse events, highlighting the need for improved safety protocols in pediatric research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. Yuill, K., Carandang, C.[2013]

A school program was developed in Italy to promote mental health and prevent mental illness, featuring a manual with 18 chapters focused on essential skills like communication, problem-solving, and stress management.

The manual was positively received by 253 students across 10 high schools and 1 middle school, indicating its acceptability, while its effectiveness in promoting mental health is still under evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A student manual for promoting mental health among high school students. Gigantesco, A., Del Re, D., Cascavilla, I.[2019]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12027138/

School-Based Mental Health Education: Program ...

A survey on program content was administered to assess program effectiveness. Data collected between 2020 and 2023 from four schools yielded 473 responses. A ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0190740920321526

Outcomes, evidence-based treatments, and disparities in a ...

Highlights · Overall youth outpatient mental health treatment outcomes were modest. · Females, 7 to 12 year olds, and non-Hispanic White youth improved most.

3.

psychiatryonline.org

psychiatryonline.org/doi/full/10.1176/appi.ps.20230542

Assessing the Evidence Base for School-Based Promotion ...

The AEB series includes interventions that aim to reduce the development of mental health conditions among students and the associated clinical ...

4.

frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1241469/full

Community-based programs for youth with mental health ...

Results: Twenty-seven psychosocial programs that provide leisure and/or social activities and encourage the promotion of adolescent mental ...

5.

cdc.gov

cdc.gov/yrbs/results/2023-yrbs-results.html

2023 Youth Risk Behavior Survey Results

Promising recent improvements from 2021 to 2023. The percentage of students overall who had persistent feelings of sadness or hopelessness (42% ...

6.

cdc.gov

cdc.gov/yrbs/dstr/index.html

YRBS Data Summary & Trends Report

The Youth Risk Behavior Survey Data Summary & Trends Report provides data on health behaviors and experiences of high school students in the United States.

7.

withpower.com

withpower.com/trial/phase-mental-health-10-2024-d9902

Mental Health Program for Youth · Info for Participants

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.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4289426/

The SAFETY Program: A Treatment-Development Trial of a ...

There was one reported suicide attempt by 3-months and another by 6-months, yielding cumulative attempt rates of 3% and 6% at 3 and 6-months respectively.

9.

samhsa.gov

samhsa.gov/data/

SAMHSA Data

The N-SUMHSS provides information about the number and characteristics of public and private substance use and mental health treatment facilities nationwide.

10.

hhs.gov

hhs.gov/surgeongeneral/reports-and-publications/youth-mental-health/index.html

Youth Mental Health

We've seen significant increases in certain mental health disorders in youth, including depression, anxiety, and suicidal ideation.