ALLY Program for Psychological Distress

(ALLY Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a school-based program called ALLY, which aims to boost students' well-being and reduce feelings of depression, anxiety, and stress. The program supports youth using positive psychology techniques. Participants will either join the ALLY program or a control group that does not receive the program. Students at participating schools who want to improve their mental health and well-being might be a good fit for this trial. As an unphased trial, this study offers students a unique opportunity to enhance their mental health through innovative techniques.

What prior data suggests that the ALLY program is safe for youth?

Research shows that the ALLY Program aims to improve mental well-being in young people. Although clinical trials have not tested it for safety like new drugs, similar programs have been used safely in other contexts. For example, programs teaching people how to support others have been implemented without major safety issues.

The ALLY Program for Psychological Distress is in a "Not Applicable" phase, meaning it differs from typical drug trials that undergo multiple safety stages. This trial focuses on a psychological program rather than medication. Psychological programs generally pose fewer risks compared to drug treatments.

In summary, while direct safety data for the ALLY Program is unavailable, similar programs have been well-received and are considered safe. Participants do not take any medications, so the risk of adverse side effects is much lower. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for psychological distress, which often rely on medications or talk therapy, the ALLY Program is unique because it focuses on developing personalized coping strategies through a structured, supportive framework. Most treatments aim to reduce symptoms through pharmacological means or generic therapeutic approaches, but ALLY emphasizes individualized support to empower participants in managing their own distress. Researchers are excited about this approach because it offers a more tailored solution, potentially leading to more sustainable mental health improvements by addressing the specific needs and strengths of each individual.

What evidence suggests that the ALLY program is effective for reducing psychological distress?

Research has shown that programs like ALLY, which participants in this trial may receive, can help reduce mental distress. In past studies, participants experienced less distress and fewer problems, with benefits lasting at least three months. One study found that these programs also increased support from friends, encouraged people to seek help, and boosted self-esteem. By reducing negative thoughts related to mental health, they help individuals feel better about themselves. Overall, these findings suggest that the ALLY program can improve young people's well-being and lessen symptoms of depression, anxiety, and stress. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for students enrolled at participating schools, with no exclusions. It's designed to help those who may be experiencing depression, anxiety, stress or suicidal thoughts by improving their overall well-being.

Inclusion Criteria

Students enrolled at participating schools

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Program Implementation

Participants engage in the school-based, multicomponent positive psychology program aimed at increasing well-being and reducing psychological distress

3 months

Follow-up

Participants are monitored for changes in symptoms of anxiety, depression, and self-efficacy

3 months

What Are the Treatments Tested in This Trial?

Interventions

• ALLY

Trial Overview The ALLY program being tested is a school-based positive psychology intervention. It aims to boost youth well-being and reduce psychological distress symptoms like depression and anxiety through various supportive components.

How Is the Trial Designed?

Group I: Program Experimental Treatment 1 Intervention

Group II: Control Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17679246/

consumer distress, disability and service usage Patients who attended three or more treatment sessions showed reduced distress and disability, and gains were maintained three months later. Health service ...

2. researchgate.net researchgate.net/publication/372985685_Exploratory_study_of_an_ally_training_program_for_mental_health_support

Exploratory study of an ally training program for mental ... The program increased peer-support, help-seeking intentions and self-esteem, while reducing internalized stigma and stigma stress. Findings provide preliminary ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1326020023015212

consumer distress, disability and service usage Objective: To evaluate a Better Outcomes of Mental Health Care Access to Allied Psychological Services Program for general practice patients referred for high‐ ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17464692/

Better outcomes in mental health care: impact of different ... Conclusions: Overwhelmingly, the Access to Allied Psychological Services projects are having a positive impact for patients in terms of their level of ...

5. ijmhs.biomedcentral.com ijmhs.biomedcentral.com/articles/10.1186/s13033-016-0092-4

Achievements of the Australian Access to Allied Psychological ... Importantly, the ATAPS program achieved considerable positive clinical outcomes for consumers with recorded outcome data. The socio-demographic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11795962/

Empowering workplace allies for lesbian, gay, bisexual ... This scoping review aimed to summarize available evidence regarding the effectiveness of workplace allies for LGBT employees in preventing/minimizing ...

7. iro.uiowa.edu iro.uiowa.edu/view/pdfCoverPage?instCode=01IOWA_INST&filePid=13893172590002771&download=true

The development, implementation, and evaluation of an ... Finally, I report on the findings of a program evaluation conducted on this training to observe the impact it has on mental health providers' self-reported ...

8. eprints.whiterose.ac.uk eprints.whiterose.ac.uk/id/eprint/200907/1/Cochrane%20Evidence%20Synthesis%20and%20Methods%20-%202023%20-%20Ho%20-%20Empowering%20workplace%20allies%20for%20lesbian%20%20gay%20%20bisexual%20%20and.pdf

Empowering workplace allies for lesbian gay bisexual and. ... This is a repository copy of Empowering workplace allies for lesbian, gay, bisexual, and transgender employees to prevent and minimize ...

9. withpower.com withpower.com/trial/phase-suicidal-ideation-6-2021-4e62e

ALLY Program for Psychological Distress (ALLY Trial) The ALLY medical study, being run by University of Colorado, Denver, needs participants to evaluate whether ALLY will have tolerable side effects & efficacy ...