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Clinical Trials/NCT04104841
NCT04104841
Completed
N/A

School-Based Depression Prevention for Adolescents With ADHD

University of Maryland, College Park1 site in 1 country50 target enrollmentAugust 7, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
University of Maryland, College Park
Enrollment
50
Locations
1
Primary Endpoint
Children's Depression Inventory, 2nd Edition (CDI-2)
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 7, 2018
End Date
July 11, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Children's Depression Inventory, 2nd Edition (CDI-2)

Time Frame: 12-week follow-up

Adolescent and parent reported depressive symptoms

Secondary Outcomes

  • Suicide Behavior Questionnaire(12-week follow-up)
  • Affective Reactivity Index(12-week follow-up)
  • Mirror Tracing Persistence Task(12-week follow-up)
  • Tripartite Pleasure Inventory(12-week follow-up)
  • Behavioral Activation for Depression Scale(12-week follow-up)
  • Emotion Regulation Checklist(12-week follow-up)
  • Difficulties in Emotion Regulation(12-week follow-up)
  • Impairment Rating Scale(12-week follow-up)
  • Reward Probability Index(12-week follow-up)
  • Balloon Analog Risk Task(12-week follow-up)

Study Sites (1)

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