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

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Will I have to stop taking my current medications?

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

Is the Mental Health Program for Youth generally safe for children?

Research on treatments like the Mental Health Program for Youth shows that safety monitoring is important, especially for children. Studies suggest that close clinical monitoring can help minimize risks of unexpected side effects, and there is a need for more research to ensure safety in pediatric treatments. ^{1 2 3 4 5}

How is the Youth Series treatment different from other mental health treatments for youth?

The Youth Series treatment is unique because it combines multiple approaches, including community media campaigns, school-based social skills programs, and life skills training, to promote mental health among young people. This comprehensive strategy aims to address various aspects of mental health, unlike treatments that focus on a single method. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Youth Series in the Mental Health Program for Youth?

Research shows that single-session interventions (SSIs) can be effective for youth psychiatric problems, making mental health services more accessible and cost-effective. Additionally, integrated programs for early recognition and treatment of severe mental disorders in youth have shown promise in improving service accessibility and outcomes. ^{11 12 13 14 15}

Who Is on the Research Team?

Kate Williams, Masters

Principal Investigator

Excellence in Giving Insights

Lincoln Lau, PhD

Principal Investigator

University of Toronto

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

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]

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]

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]

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]

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]

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 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]

Citations

1. Australia pubmed.ncbi.nlm.nih.gov

Characteristics and treatment outcomes of children and adolescents accessing treatment in Child and Youth Mental Health Services. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Little Treatments, Promising Effects? Meta-Analysis of Single-Session Interventions for Youth Psychiatric Problems. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Integrated Programs for Early Recognition of Severe Mental Disorders: Recommendations From an Italian Multicenter Project. [2020]

4. Australia pubmed.ncbi.nlm.nih.gov

An examination of frequent nursing interventions and outcomes in an adolescent psychiatric inpatient unit. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Outcome and follow-up study of an adolescent psychiatric day treatment school program. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Age-grouped differences in adverse drug events from psychotropic medication. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Mental health promotion for young people: a proposal for a tripartite approach. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Early findings of a nurse-led youth activist program in mind caring. [2023]

13. Australia pubmed.ncbi.nlm.nih.gov

A systematic mapping review of interventions to improve adolescent mental health literacy, attitudes and behaviours. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Study protocol for a school-based single group pragmatic trial to promote resilience in youth: Building Resilience for Healthy Kids. [2023]

15. Italy pubmed.ncbi.nlm.nih.gov

A student manual for promoting mental health among high school students. [2019]