School-Based Depression Prevention for Adolescents With ADHD

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder; Depressive Symptoms
• Interventions: Behavioral: Behaviorally Enhancing Adolescents' Mood in Schools; Behavioral: Usual Care

• Registration Number: NCT04104841
• Lead Sponsor: University of Maryland, College Park

Brief Summary

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

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).

Study Timeline

• Study Start: 2018-08-07
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Primary Completion: 2021-07-01
• Study Completion: 2022-07-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS)	Behaviorally Enhancing Adolescents' Mood in Schools	8-session modified behavioral activation program
Usual Care	Usual Care	Referrals to usual care

Primary Outcome Measures

Name	Time	Method
Children's Depression Inventory, 2nd Edition (CDI-2)	12-week follow-up	Adolescent and parent reported depressive symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 College Park, Maryland, United States