NCT05025657

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

3.9 years

First QC Date

August 24, 2021

Last Update Submit

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

EXPERIMENTAL
Behavioral: ALLY

Control

PLACEBO COMPARATOR
Behavioral: ALLY

Interventions

ALLYBEHAVIORAL

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

ControlProgram

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersSuicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSuicideSelf-Injurious Behavior

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

Locations