School-Based Depression Prevention for Adolescents With ADHD

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2021

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).

Interventions

  • Behavioral: Behaviorally Enhancing Adolescents’ Mood in Schools
    • 8-session modified behavioral activation intervention
  • Behavioral: Usual Care
    • Referral to school mental health provider, social worker, or community care.

Arms, Groups and Cohorts

  • Experimental: Behaviorally Enhancing Adolescents’ Mood in Schools (BEAMS)
    • 8-session modified behavioral activation program
  • Active Comparator: Usual Care
    • Referrals to usual care

Clinical Trial Outcome Measures

Primary Measures

  • Children’s Depression Inventory, 2nd Edition (CDI-2)
    • Time Frame: After the 8-week preventive intervention
    • Adolescent and parent reported depressive symptoms
  • Children’s Depression Inventory, 2nd Edition (CDI-2)
    • Time Frame: 4-week follow-up
    • Adolescent and parent reported depressive symptoms
  • Children’s Depression Inventory, 2nd Edition (CDI-2)
    • Time Frame: 12-week follow-up
    • Adolescent and parent reported depressive symptoms

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Maryland, College Park
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Meinzer, PhD, Principal Investigator, University of Maryland

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