School-Based Depression Prevention for Adolescents With ADHD (BEAMS)

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 Overview

• Status: Completed
• Conditions: Depressive Symptoms; Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Behaviorally Enhancing Adolescents' Mood in Schools; Behavioral: 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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • College Park, Maryland, United States, 20742
      • University of Maryland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS); 8-session modified behavioral activation program	Behavioral: Behaviorally Enhancing Adolescents' Mood in Schools; 8-session modified behavioral activation intervention
Active Comparator: Usual Care; Referrals to usual care	Behavioral: Usual Care; Referral to school mental health provider, social worker, or community care.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Maryland, College Park
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Michael Meinzer, PhD, University of Maryland

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Depression; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: MH117086; R34MH117086 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No