Advocates for All Youth

Suicidal Ideation Clinical Trial

— ALLY  

Official title:

Advocates for All Youth

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05025657
• Other study ID #: 21-3790
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Advocates for ALLY Youth (ALLY) is a universal, school-based, multicomponent positive psychology program aimed to increase youth's well-being and reduce symptoms of psychological distress including depression, anxiety, and stress.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

Inclusion Criteria:

• students enrolled at participating schools

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Depression, Anxiety
• Self Efficacy
• Suicidal Ideation

Intervention

Behavioral:
• ALLY
ALLY is a universal, school-based prevention program that takes place during the school day with individual students over 6 weeks.

Locations

Country	Name	City	State
United States	Loachapoka Elementary School	Loachapoka	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of Anxiety and Depression	The PROMIS Emotional Distress Anxiety and PROMIS Emotional Distress Depressive Symptoms scales (Irwin et al., 2010) were used to assess negative affectivity. Each 8-item short form elicits responses from the student on a 5-point Likert scale from "never" to "always" over the past 7-day period. The items are summed for a score ranging from 8 to 40 with higher scores indicating more elevated negative affectivity. Scores are then translated to T-scores, with T-scores below 55 classified as "normal," T-scores between 55 and 60 classified as "mild," T-scores between 60 and 70 classified as "moderate," and T-scores above 70 classified as "severe." The measure demonstrated satisfactory goodness of fit and adequate internal reliability (a = 0.85) in children and adolescents aged 8-17 years (Irwin et al., 2010). Elevated negative affectivity was endorsed in cases when students scored mild or higher for symptoms of both depression and anxiety on each of the PROMIS scales.	3 months
Secondary	Self-efficacy	The Self-Efficacy Questionnaire for Children (SEQ-C) validated among adolescents aged 12-19 years was used to assess self-efficacy (Muris, 2001). This 24-item survey assesses three key domains of self-efficacy: (1) social self-efficacy, defined as perceived capability for peer relationships and assertiveness; (2) academic self-efficacy, which is the perceived capability to manage one's own learning behavior, to master academic subjects, and to fulfill academic expectations; and (3) emotional self-efficacy, which is the perceived capability of coping with negative emotions. Each item is scored on a 5-point Likert scale ranging from "not at all" to "very well." Subscale scores and an overall or total self-efficacy score are obtained by summing respective items, with higher scores indicating greater self-efficacy.	3 months