Advocates for All Youth (ALLY)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Suicidal Ideation; Depression, Anxiety; Self Efficacy
• Intervention / Treatment: Behavioral: ALLY

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Loachapoka, Alabama, United States, 36865
      • Loachapoka Elementary School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• students enrolled at participating schools

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Behavioral: ALLY; ALLY is a universal, school-based prevention program that takes place during the school day with individual students over 6 weeks.
Experimental: Program	Behavioral: ALLY; ALLY is a universal, school-based prevention program that takes place during the school day with individual students over 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (α = 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: 21-3790

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No