Attention Deficit Hyperactivity DisorderBEAMSNCT04104841
School-Based Depression Prevention for Adolescents With ADHD
A study testing Behaviorally Enhancing Adolescents' Mood in Schools in people with Attention Deficit Hyperactivity Disorder and Depressive Symptoms, run by University of Maryland, College Park at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Depressive Symptoms
- What is being tested?
- Behaviorally Enhancing Adolescents' Mood in Schools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 11 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland
College Park, Maryland, 20742
About this study
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.
Read the 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).
- Being tested
- Behaviorally Enhancing Adolescents' Mood in Schools, Usual Care
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviorally Enhancing Adolescents' Mood in SchoolsBehavioural
8-session modified behavioral activation intervention
Usual CareBehavioural
Referral to school mental health provider, social worker, or community care.
| Study group | Role | What they receive |
|---|---|---|
| Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS) | Experimental | 8-session modified behavioral activation program Receives: Behavioral: Behaviorally Enhancing Adolescents' Mood in Schools |
| Usual Care | Active comparator | Referrals to usual care Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Depression Inventory, 2nd Edition (CDI-2)
Adolescent and parent reported depressive symptoms
Measured: After the 8-week preventive intervention
Children's Depression Inventory, 2nd Edition (CDI-2)
Adolescent and parent reported depressive symptoms
Measured: 4-week follow-up
Children's Depression Inventory, 2nd Edition (CDI-2)
Adolescent and parent reported depressive symptoms
Measured: 12-week follow-up
Secondary outcomes (30)
Affective Reactivity Index
Adolescent and parent reported irritability
Measured: After the 8-week preventive intervention
Affective Reactivity Index
Adolescent and parent reported irritability
Measured: 4-week follow-up
Affective Reactivity Index
Adolescent and parent reported irritability
Measured: 12-week follow-up
Suicide Behavior Questionnaire
Adolescent reported suicidal thoughts and behaviors
Measured: After the 8-week preventive intervention
Suicide Behavior Questionnaire
Adolescent reported suicidal thoughts and behaviors
Measured: 4-week follow-up
Suicide Behavior Questionnaire
Adolescent reported suicidal thoughts and behaviors
Measured: 12-week follow-up
Emotion Regulation Checklist
Parent reported emotion dysregulation
Measured: After the 8-week preventive intervention
Emotion Regulation Checklist
Parent reported emotion dysregulation
Measured: 4-week follow-up
Emotion Regulation Checklist
Parent reported emotion dysregulation
Measured: 12-week follow-up
Difficulties in Emotion Regulation
Adolescent reported emotion dysregulation
Measured: After the 8-week preventive intervention
Difficulties in Emotion Regulation
Adolescent reported emotion dysregulation
Measured: 4-week follow-up
Difficulties in Emotion Regulation
Adolescent reported emotion dysregulation
Measured: 12-week follow-up
Mirror Tracing Persistence Task
Emotion regulation behavioral task
Measured: After the 8-week preventive intervention
Mirror Tracing Persistence Task
Emotion regulation behavioral task
Measured: 4-week follow-up
Mirror Tracing Persistence Task
Emotion regulation behavioral task
Measured: 12-week follow-up
Tripartite Pleasure Inventory
Adolescent reported reward responsiveness
Measured: After the 8-week preventive intervention
Tripartite Pleasure Inventory
Adolescent reported reward responsiveness
Measured: 4-week follow-up
Tripartite Pleasure Inventory
Adolescent reported reward responsiveness
Measured: 12-week follow-up
Reward Probability Index
Measure of adolescent reported environmental reward
Measured: After the 8-week preventive intervention
Reward Probability Index
Measure of adolescent reported environmental reward
Measured: 4-week follow-up
Reward Probability Index
Measure of adolescent reported environmental reward
Measured: 12-week follow-up
Behavioral Activation for Depression Scale
Adolescent reported measure of behavioral activation and avoidance
Measured: After the 8-week preventive intervention
Behavioral Activation for Depression Scale
Adolescent reported measure of behavioral activation and avoidance
Measured: 4-week follow-up
Behavioral Activation for Depression Scale
Adolescent reported measure of behavioral activation and avoidance
Measured: 12-week follow-up
Balloon Analog Risk Task
Positive reinforcement
Measured: After the 8-week preventive intervention
Balloon Analog Risk Task
Positive reinforcement
Measured: 4-week follow-up
Balloon Analog Risk Task
Positive reinforcement
Measured: 12-week follow-up
Impairment Rating Scale
Parent- and teacher- report of global impairment
Measured: After the 8-week preventive intervention
Impairment Rating Scale
Parent- and teacher- report of global impairment
Measured: 4-week follow-up
Impairment Rating Scale
Parent- and teacher- report of global impairment
Measured: 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start7 Aug 2018
- Primary completion1 Jul 2021
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michael Meinzer, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104841
- Sponsor's protocol ID
- MH117086
- Other IDs
- R34MH117086
- Acronym
- BEAMS
- Status last verified
- Dec 2023
- First submitted
- 24 Sep 2019
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-Based Depression Prevention for Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT04104841
- Acronym / sponsor ID
- BEAMS / MH117086
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS) | Experimental | Behavioral: Behaviorally Enhancing Adolescents' Mood in Schools8-session modified behavioral activation program |
| Usual Care | Active comparator | Behavioral: Usual CareReferrals to usual care |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behaviorally Enhancing Adolescents' Mood in Schools8-session modified behavioral activation intervention | Behavioural | Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS) |
| Usual CareReferral to school mental health provider, social worker, or community care. | Behavioural | Usual Care |
Primary outcome
Children's Depression Inventory, 2nd Edition (CDI-2)
Time frame: After the 8-week preventive intervention
Adolescent and parent reported depressive symptoms
Children's Depression Inventory, 2nd Edition (CDI-2)
Time frame: 4-week follow-up
Adolescent and parent reported depressive symptoms
Children's Depression Inventory, 2nd Edition (CDI-2)
Time frame: 12-week follow-up
Adolescent and parent reported depressive symptoms
30 secondary outcomes
Affective Reactivity Index
Time frame: After the 8-week preventive intervention
Affective Reactivity Index
Time frame: 4-week follow-up
Affective Reactivity Index
Time frame: 12-week follow-up
Suicide Behavior Questionnaire
Time frame: After the 8-week preventive intervention
Suicide Behavior Questionnaire
Time frame: 4-week follow-up
Suicide Behavior Questionnaire
Time frame: 12-week follow-up
Emotion Regulation Checklist
Time frame: After the 8-week preventive intervention
Emotion Regulation Checklist
Time frame: 4-week follow-up
Emotion Regulation Checklist
Time frame: 12-week follow-up
Difficulties in Emotion Regulation
Time frame: After the 8-week preventive intervention
Difficulties in Emotion Regulation
Time frame: 4-week follow-up
Difficulties in Emotion Regulation
Time frame: 12-week follow-up
Mirror Tracing Persistence Task
Time frame: After the 8-week preventive intervention
Mirror Tracing Persistence Task
Time frame: 4-week follow-up
Mirror Tracing Persistence Task
Time frame: 12-week follow-up
Tripartite Pleasure Inventory
Time frame: After the 8-week preventive intervention
Tripartite Pleasure Inventory
Time frame: 4-week follow-up
Tripartite Pleasure Inventory
Time frame: 12-week follow-up
Reward Probability Index
Time frame: After the 8-week preventive intervention
Reward Probability Index
Time frame: 4-week follow-up
Reward Probability Index
Time frame: 12-week follow-up
Behavioral Activation for Depression Scale
Time frame: After the 8-week preventive intervention
Behavioral Activation for Depression Scale
Time frame: 4-week follow-up
Behavioral Activation for Depression Scale
Time frame: 12-week follow-up
Balloon Analog Risk Task
Time frame: After the 8-week preventive intervention
Balloon Analog Risk Task
Time frame: 4-week follow-up
Balloon Analog Risk Task
Time frame: 12-week follow-up
Impairment Rating Scale
Time frame: After the 8-week preventive intervention
Impairment Rating Scale
Time frame: 4-week follow-up
Impairment Rating Scale
Time frame: 12-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Meinzer, PhD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviorally Enhancing Adolescents' Mood in Schools in people with Attention Deficit Hyperactivity Disorder and Depressive Symptoms, run by University of Maryland, College Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Depression Inventory, 2nd Edition (CDI-2) (time frame: After the 8-week preventive intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.