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

December 20, 2023 updated by: University of Maryland, College Park
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Andrea Chronis-Tuscano, PhD
  • Phone Number: 301-405-9640
  • Email: achronis@umd.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Children's Depression Inventory, 2nd Edition (CDI-2)
Time Frame: After the 8-week preventive intervention
Adolescent and parent reported depressive symptoms
After the 8-week preventive intervention
Children's Depression Inventory, 2nd Edition (CDI-2)
Time Frame: 4-week follow-up
Adolescent and parent reported depressive symptoms
4-week follow-up
Children's Depression Inventory, 2nd Edition (CDI-2)
Time Frame: 12-week follow-up
Adolescent and parent reported depressive symptoms
12-week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Affective Reactivity Index
Time Frame: After the 8-week preventive intervention
Adolescent and parent reported irritability
After the 8-week preventive intervention
Affective Reactivity Index
Time Frame: 4-week follow-up
Adolescent and parent reported irritability
4-week follow-up
Affective Reactivity Index
Time Frame: 12-week follow-up
Adolescent and parent reported irritability
12-week follow-up
Suicide Behavior Questionnaire
Time Frame: After the 8-week preventive intervention
Adolescent reported suicidal thoughts and behaviors
After the 8-week preventive intervention
Suicide Behavior Questionnaire
Time Frame: 4-week follow-up
Adolescent reported suicidal thoughts and behaviors
4-week follow-up
Suicide Behavior Questionnaire
Time Frame: 12-week follow-up
Adolescent reported suicidal thoughts and behaviors
12-week follow-up
Emotion Regulation Checklist
Time Frame: After the 8-week preventive intervention
Parent reported emotion dysregulation
After the 8-week preventive intervention
Emotion Regulation Checklist
Time Frame: 4-week follow-up
Parent reported emotion dysregulation
4-week follow-up
Emotion Regulation Checklist
Time Frame: 12-week follow-up
Parent reported emotion dysregulation
12-week follow-up
Difficulties in Emotion Regulation
Time Frame: After the 8-week preventive intervention
Adolescent reported emotion dysregulation
After the 8-week preventive intervention
Difficulties in Emotion Regulation
Time Frame: 4-week follow-up
Adolescent reported emotion dysregulation
4-week follow-up
Difficulties in Emotion Regulation
Time Frame: 12-week follow-up
Adolescent reported emotion dysregulation
12-week follow-up
Mirror Tracing Persistence Task
Time Frame: After the 8-week preventive intervention
Emotion regulation behavioral task
After the 8-week preventive intervention
Mirror Tracing Persistence Task
Time Frame: 4-week follow-up
Emotion regulation behavioral task
4-week follow-up
Mirror Tracing Persistence Task
Time Frame: 12-week follow-up
Emotion regulation behavioral task
12-week follow-up
Tripartite Pleasure Inventory
Time Frame: After the 8-week preventive intervention
Adolescent reported reward responsiveness
After the 8-week preventive intervention
Tripartite Pleasure Inventory
Time Frame: 4-week follow-up
Adolescent reported reward responsiveness
4-week follow-up
Tripartite Pleasure Inventory
Time Frame: 12-week follow-up
Adolescent reported reward responsiveness
12-week follow-up
Reward Probability Index
Time Frame: After the 8-week preventive intervention
Measure of adolescent reported environmental reward
After the 8-week preventive intervention
Reward Probability Index
Time Frame: 4-week follow-up
Measure of adolescent reported environmental reward
4-week follow-up
Reward Probability Index
Time Frame: 12-week follow-up
Measure of adolescent reported environmental reward
12-week follow-up
Behavioral Activation for Depression Scale
Time Frame: After the 8-week preventive intervention
Adolescent reported measure of behavioral activation and avoidance
After the 8-week preventive intervention
Behavioral Activation for Depression Scale
Time Frame: 4-week follow-up
Adolescent reported measure of behavioral activation and avoidance
4-week follow-up
Behavioral Activation for Depression Scale
Time Frame: 12-week follow-up
Adolescent reported measure of behavioral activation and avoidance
12-week follow-up
Balloon Analog Risk Task
Time Frame: After the 8-week preventive intervention
Positive reinforcement
After the 8-week preventive intervention
Balloon Analog Risk Task
Time Frame: 4-week follow-up
Positive reinforcement
4-week follow-up
Balloon Analog Risk Task
Time Frame: 12-week follow-up
Positive reinforcement
12-week follow-up
Impairment Rating Scale
Time Frame: After the 8-week preventive intervention
Parent- and teacher- report of global impairment
After the 8-week preventive intervention
Impairment Rating Scale
Time Frame: 4-week follow-up
Parent- and teacher- report of global impairment
4-week follow-up
Impairment Rating Scale
Time Frame: 12-week follow-up
Parent- and teacher- report of global impairment
12-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, College Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Meinzer, PhD, University of Maryland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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