Clinical Trials Directory

Trials / Completed

CompletedNCT04104841

School-Based Depression Prevention for Adolescents With ADHD

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
University of Maryland, College Park · Academic / Other
Sex
All
Age
14 Years – 18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALBehaviorally Enhancing Adolescents' Mood in Schools8-session modified behavioral activation intervention
BEHAVIORALUsual CareReferral to school mental health provider, social worker, or community care.

Timeline

Start date
2018-08-07
Primary completion
2021-07-01
Completion
2022-07-11
First posted
2019-09-26
Last updated
2023-12-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04104841. Inclusion in this directory is not an endorsement.