Advocates for All Youth

Study Overview
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Brief Summary
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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.

Official Title
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Advocates for All Youth

Conditions
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Depression, Anxiety, Self Efficacy, Suicidal Ideation

Intervention / Treatment
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* Behavioral: ALLY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: students enrolled at participating schools Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |