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School-Based Depression Prevention for Adolescents With ADHD

NCT ID: NCT04104841

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-07

Study Completion Date

2022-07-11

Brief Summary

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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

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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

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Attention Deficit Hyperactivity Disorder Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS)

8-session modified behavioral activation program

Group Type EXPERIMENTAL

Behaviorally Enhancing Adolescents' Mood in Schools

Intervention Type BEHAVIORAL

8-session modified behavioral activation intervention

Usual Care

Referrals to usual care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Referral to school mental health provider, social worker, or community care.

Interventions

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Behaviorally Enhancing Adolescents' Mood in Schools

8-session modified behavioral activation intervention

Intervention Type BEHAVIORAL

Usual Care

Referral to school mental health provider, social worker, or community care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Maryland, College Park

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Meinzer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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University of Maryland

College Park, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH117086

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH117086

Identifier Type: -

Identifier Source: org_study_id