College Park, Maryland 20742

  • Depressive Symptoms

Purpose:

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 we will examine its effectiveness in reducing depressive symptoms and improving emotion regulation and reward responsivity, compared to usual care.


Study summary:

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, we 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, we 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, we 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. We 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. We 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).


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


NCT ID:

NCT04104841


Primary Contact:

Principal Investigator
Michael Meinzer, PhD
University of Maryland, College Park

Andrea Chronis-Tuscano, PhD
Phone: 301-405-9640
Email: achronis@umd.edu


Backup Contact:

N/A


Location Contact:

College Park, Maryland 20742
United States

Joseph Smith
Phone: 301-405-0678
Email: jsmith54@umd.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 02, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.