School-Based Depression Prevention for Adolescents With ADHD

Study Overview
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Brief Summary
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The purpose of this study is to develop a modified behavioral activation program in adolescents with ADHD to be implemented by school mental health providers in an urban, low-income school district. Subsequently the investigators will examine its effectiveness in reducing depressive symptoms and improving emotion regulation and reward responsivity, compared to usual care.

Detailed Description
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Children with ADHD are at elevated risk for depression in adolescence and young adulthood, and this comorbidity is associated with far greater impairment than either disorder alone, including higher rates of inpatient hospitalization and increased risk for suicidal ideation and behavior. Despite these adverse outcomes, existing evidence-based interventions for ADHD have not demonstrated effects in reducing depressive symptoms nor do established depression prevention programs work as well for adolescents with ADHD. Reward responsivity (RR) and emotion regulation (ER) are two key factors demonstrated to mediate the association between ADHD and depression and are thus key targets for prevention. In an effort to address the gap between access and utilization of mental health care, which is especially stark among adolescents with ADHD, the investigators aim to develop and test a modified behavioral activation prevention program [Behaviorally Enhancing Adolescents' Mood in Schools (BEAM-S)] that incorporates modules to directly target these purported mechanisms. In line with the Deployment-Focused Model of Intervention Development and Testing, the investigators will develop a program that can be easily implemented and sustainable in the high school setting as delivered by school mental health staff that reduces depression and improves overall functioning in adolescents with ADHD, by way of improving RR and ER. As a first step, the investigators will conduct focus groups with community stakeholders (e.g., school mental health providers, school administration, adolescents, parents, teachers) to develop an acceptable and sustainable selected and indicated prevention program for school staff to utilize. The investigators will then initially train school staff to deliver this prevention program via to pilot the intervention for implementation of the prevention program in a case series to evaluate preliminary feasibility. The investigators will then conduct a stage 1 RCT with a hybrid-type 1 implementation effectiveness design in three high schools where adolescents will be randomized to either the BEAM-S condition (n= 54) or treatment as usual (n = 54). Finally, qualitative and quantitative data from aims 1-3 will be used to prepare final procedures for a future large-scale effectiveness trial R01 (aim 4).

Official Title
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School-Based Depression Prevention for Adolescents With ADHD

Conditions
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Attention Deficit Hyperactivity Disorder, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Behaviorally Enhancing Adolescents' Mood in Schools
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in a participating Baltimore City Public High School DSM-5 Diagnosis of attention-deficit/hyperactivity disorder (ADHD) Depressive symptoms above T=65 on the Children's Depression Inventory (CDI) Exclusion Criteria: History of seizures or neurological problems DSM-diagnosis of Pervasive Developmental Disorder Full scale IQ below 70 Current depressive symptoms or active suicidality at severe levels where more intensive services would be warranted

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS)<br>8-session modified behavioral activation program | Behavioral: Behaviorally Enhancing Adolescents' Mood in Schools<br>* 8-session modified behavioral activation intervention<br>|
| Active Comparator: Usual Care<br>Referrals to usual care | Behavioral: Usual Care<br>* Referral to school mental health provider, social worker, or community care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Depression Inventory, 2nd Edition (CDI-2) | Adolescent and parent reported depressive symptoms | After the 8-week preventive intervention | 
| Children's Depression Inventory, 2nd Edition (CDI-2) | Adolescent and parent reported depressive symptoms | 4-week follow-up | 
| Children's Depression Inventory, 2nd Edition (CDI-2) | Adolescent and parent reported depressive symptoms | 12-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Affective Reactivity Index | Adolescent and parent reported irritability | After the 8-week preventive intervention | 
| Affective Reactivity Index | Adolescent and parent reported irritability | 4-week follow-up | 
| Affective Reactivity Index | Adolescent and parent reported irritability | 12-week follow-up | 
| Suicide Behavior Questionnaire | Adolescent reported suicidal thoughts and behaviors | After the 8-week preventive intervention | 
| Suicide Behavior Questionnaire | Adolescent reported suicidal thoughts and behaviors | 4-week follow-up | 
| Suicide Behavior Questionnaire | Adolescent reported suicidal thoughts and behaviors | 12-week follow-up | 
| Emotion Regulation Checklist | Parent reported emotion dysregulation | After the 8-week preventive intervention | 
| Emotion Regulation Checklist | Parent reported emotion dysregulation | 4-week follow-up | 
| Emotion Regulation Checklist | Parent reported emotion dysregulation | 12-week follow-up | 
| Difficulties in Emotion Regulation | Adolescent reported emotion dysregulation | After the 8-week preventive intervention | 
| Difficulties in Emotion Regulation | Adolescent reported emotion dysregulation | 4-week follow-up | 
| Difficulties in Emotion Regulation | Adolescent reported emotion dysregulation | 12-week follow-up | 
| Mirror Tracing Persistence Task | Emotion regulation behavioral task | After the 8-week preventive intervention | 
| Mirror Tracing Persistence Task | Emotion regulation behavioral task | 4-week follow-up | 
| Mirror Tracing Persistence Task | Emotion regulation behavioral task | 12-week follow-up | 
| Tripartite Pleasure Inventory | Adolescent reported reward responsiveness | After the 8-week preventive intervention | 
| Tripartite Pleasure Inventory | Adolescent reported reward responsiveness | 4-week follow-up | 
| Tripartite Pleasure Inventory | Adolescent reported reward responsiveness | 12-week follow-up | 
| Reward Probability Index | Measure of adolescent reported environmental reward | After the 8-week preventive intervention | 
| Reward Probability Index | Measure of adolescent reported environmental reward | 4-week follow-up | 
| Reward Probability Index | Measure of adolescent reported environmental reward | 12-week follow-up | 
| Behavioral Activation for Depression Scale | Adolescent reported measure of behavioral activation and avoidance | After the 8-week preventive intervention | 
| Behavioral Activation for Depression Scale | Adolescent reported measure of behavioral activation and avoidance | 4-week follow-up | 
| Behavioral Activation for Depression Scale | Adolescent reported measure of behavioral activation and avoidance | 12-week follow-up | 
| Balloon Analog Risk Task | Positive reinforcement | After the 8-week preventive intervention | 
| Balloon Analog Risk Task | Positive reinforcement | 4-week follow-up | 
| Balloon Analog Risk Task | Positive reinforcement | 12-week follow-up | 
| Impairment Rating Scale | Parent- and teacher- report of global impairment | After the 8-week preventive intervention | 
| Impairment Rating Scale | Parent- and teacher- report of global impairment | 4-week follow-up | 
| Impairment Rating Scale | Parent- and teacher- report of global impairment | 12-week follow-up |