search
Back to results

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

Primary Purpose

Attention Deficit Hyperactivity Disorder, Depressive Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behaviorally Enhancing Adolescents' Mood in Schools
Usual Care
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MarylandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS)

Usual Care

Arm Description

8-session modified behavioral activation program

Referrals to usual care

Outcomes

Primary Outcome Measures

Children's Depression Inventory, 2nd Edition (CDI-2)
Adolescent and parent reported depressive symptoms
Children's Depression Inventory, 2nd Edition (CDI-2)
Adolescent and parent reported depressive symptoms
Children's Depression Inventory, 2nd Edition (CDI-2)
Adolescent and parent reported depressive symptoms

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2019
Last Updated
September 24, 2019
Sponsor
University of Maryland, College Park
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04104841
Brief Title
School-Based Depression Prevention for Adolescents With ADHD
Acronym
BEAMS
Official Title
School-Based Depression Prevention for Adolescents With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 we 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, 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Depressive Symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS)
Arm Type
Experimental
Arm Description
8-session modified behavioral activation program
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Referrals to usual care
Intervention Type
Behavioral
Intervention Name(s)
Behaviorally Enhancing Adolescents' Mood in Schools
Intervention Description
8-session modified behavioral activation intervention
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Referral to school mental health provider, social worker, or community care.
Primary Outcome Measure Information:
Title
Children's Depression Inventory, 2nd Edition (CDI-2)
Description
Adolescent and parent reported depressive symptoms
Time Frame
After the 8-week preventive intervention
Title
Children's Depression Inventory, 2nd Edition (CDI-2)
Description
Adolescent and parent reported depressive symptoms
Time Frame
4-week follow-up
Title
Children's Depression Inventory, 2nd Edition (CDI-2)
Description
Adolescent and parent reported depressive symptoms
Time Frame
12-week follow-up
Secondary Outcome Measure Information:
Title
Affective Reactivity Index
Description
Adolescent and parent reported irritability
Time Frame
After the 8-week preventive intervention
Title
Affective Reactivity Index
Description
Adolescent and parent reported irritability
Time Frame
4-week follow-up
Title
Affective Reactivity Index
Description
Adolescent and parent reported irritability
Time Frame
12-week follow-up
Title
Suicide Behavior Questionnaire
Description
Adolescent reported suicidal thoughts and behaviors
Time Frame
After the 8-week preventive intervention
Title
Suicide Behavior Questionnaire
Description
Adolescent reported suicidal thoughts and behaviors
Time Frame
4-week follow-up
Title
Suicide Behavior Questionnaire
Description
Adolescent reported suicidal thoughts and behaviors
Time Frame
12-week follow-up
Title
Emotion Regulation Checklist
Description
Parent reported emotion dysregulation
Time Frame
After the 8-week preventive intervention
Title
Emotion Regulation Checklist
Description
Parent reported emotion dysregulation
Time Frame
4-week follow-up
Title
Emotion Regulation Checklist
Description
Parent reported emotion dysregulation
Time Frame
12-week follow-up
Title
Difficulties in Emotion Regulation
Description
Adolescent reported emotion dysregulation
Time Frame
After the 8-week preventive intervention
Title
Difficulties in Emotion Regulation
Description
Adolescent reported emotion dysregulation
Time Frame
4-week follow-up
Title
Difficulties in Emotion Regulation
Description
Adolescent reported emotion dysregulation
Time Frame
12-week follow-up
Title
Mirror Tracing Persistence Task
Description
Emotion regulation behavioral task
Time Frame
After the 8-week preventive intervention
Title
Mirror Tracing Persistence Task
Description
Emotion regulation behavioral task
Time Frame
4-week follow-up
Title
Mirror Tracing Persistence Task
Description
Emotion regulation behavioral task
Time Frame
12-week follow-up
Title
Tripartite Pleasure Inventory
Description
Adolescent reported reward responsiveness
Time Frame
After the 8-week preventive intervention
Title
Tripartite Pleasure Inventory
Description
Adolescent reported reward responsiveness
Time Frame
4-week follow-up
Title
Tripartite Pleasure Inventory
Description
Adolescent reported reward responsiveness
Time Frame
12-week follow-up
Title
Reward Probability Index
Description
Measure of adolescent reported environmental reward
Time Frame
After the 8-week preventive intervention
Title
Reward Probability Index
Description
Measure of adolescent reported environmental reward
Time Frame
4-week follow-up
Title
Reward Probability Index
Description
Measure of adolescent reported environmental reward
Time Frame
12-week follow-up
Title
Behavioral Activation for Depression Scale
Description
Adolescent reported measure of behavioral activation and avoidance
Time Frame
After the 8-week preventive intervention
Title
Behavioral Activation for Depression Scale
Description
Adolescent reported measure of behavioral activation and avoidance
Time Frame
4-week follow-up
Title
Behavioral Activation for Depression Scale
Description
Adolescent reported measure of behavioral activation and avoidance
Time Frame
12-week follow-up
Title
Balloon Analog Risk Task
Description
Positive reinforcement
Time Frame
After the 8-week preventive intervention
Title
Balloon Analog Risk Task
Description
Positive reinforcement
Time Frame
4-week follow-up
Title
Balloon Analog Risk Task
Description
Positive reinforcement
Time Frame
12-week follow-up
Title
Impairment Rating Scale
Description
Parent- and teacher- report of global impairment
Time Frame
After the 8-week preventive intervention
Title
Impairment Rating Scale
Description
Parent- and teacher- report of global impairment
Time Frame
4-week follow-up
Title
Impairment Rating Scale
Description
Parent- and teacher- report of global impairment
Time Frame
12-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Chronis-Tuscano, PhD
Phone
301-405-9640
Email
achronis@umd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Meinzer, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Smith
Phone
301-405-0678
Email
jsmith54@umd.edu
First Name & Middle Initial & Last Name & Degree
Michael C Meinzer, PhD
First Name & Middle Initial & Last Name & Degree
Andrea Chronis-Tuscano, PhD

12. IPD Sharing Statement

Learn more about this trial

School-Based Depression Prevention for Adolescents With ADHD

We'll reach out to this number within 24 hrs