Advocates for All Youth
ALLY
1 other identifier
interventional
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2021
CompletedFirst Submitted
Initial submission to the registry
August 24, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 6, 2023
December 1, 2023
3.9 years
August 24, 2021
December 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Self-efficacy
3 months
Study Arms (2)
Program
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
ALLY is a universal, school-based prevention program that takes place during the school day with individual students over 6 weeks.
Eligibility Criteria
You may qualify if:
- students enrolled at participating schools
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loachapoka Elementary School
Loachapoka, Alabama, 36865, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2021
First Posted
August 27, 2021
Study Start
July 30, 2021
Primary Completion
June 30, 2025
Study Completion
December 31, 2025
Last Updated
December 6, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share