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

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ClinicalTrials.gov Identifier: NCT04104841
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Maryland, College Park

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Depressive Symptoms Behavioral: Behaviorally Enhancing Adolescents' Mood in Schools Behavioral: Usual Care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School-Based Depression Prevention for Adolescents With ADHD
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Children's Depression Inventory, 2nd Edition (CDI-2) [ Time Frame: After the 8-week preventive intervention ]
    Adolescent and parent reported depressive symptoms

  2. Children's Depression Inventory, 2nd Edition (CDI-2) [ Time Frame: 4-week follow-up ]
    Adolescent and parent reported depressive symptoms

  3. Children's Depression Inventory, 2nd Edition (CDI-2) [ Time Frame: 12-week follow-up ]
    Adolescent and parent reported depressive symptoms


Secondary Outcome Measures :
  1. Affective Reactivity Index [ Time Frame: After the 8-week preventive intervention ]
    Adolescent and parent reported irritability

  2. Affective Reactivity Index [ Time Frame: 4-week follow-up ]
    Adolescent and parent reported irritability

  3. Affective Reactivity Index [ Time Frame: 12-week follow-up ]
    Adolescent and parent reported irritability

  4. Suicide Behavior Questionnaire [ Time Frame: After the 8-week preventive intervention ]
    Adolescent reported suicidal thoughts and behaviors

  5. Suicide Behavior Questionnaire [ Time Frame: 4-week follow-up ]
    Adolescent reported suicidal thoughts and behaviors

  6. Suicide Behavior Questionnaire [ Time Frame: 12-week follow-up ]
    Adolescent reported suicidal thoughts and behaviors

  7. Emotion Regulation Checklist [ Time Frame: After the 8-week preventive intervention ]
    Parent reported emotion dysregulation

  8. Emotion Regulation Checklist [ Time Frame: 4-week follow-up ]
    Parent reported emotion dysregulation

  9. Emotion Regulation Checklist [ Time Frame: 12-week follow-up ]
    Parent reported emotion dysregulation

  10. Difficulties in Emotion Regulation [ Time Frame: After the 8-week preventive intervention ]
    Adolescent reported emotion dysregulation

  11. Difficulties in Emotion Regulation [ Time Frame: 4-week follow-up ]
    Adolescent reported emotion dysregulation

  12. Difficulties in Emotion Regulation [ Time Frame: 12-week follow-up ]
    Adolescent reported emotion dysregulation

  13. Mirror Tracing Persistence Task [ Time Frame: After the 8-week preventive intervention ]
    Emotion regulation behavioral task

  14. Mirror Tracing Persistence Task [ Time Frame: 4-week follow-up ]
    Emotion regulation behavioral task

  15. Mirror Tracing Persistence Task [ Time Frame: 12-week follow-up ]
    Emotion regulation behavioral task

  16. Tripartite Pleasure Inventory [ Time Frame: After the 8-week preventive intervention ]
    Adolescent reported reward responsiveness

  17. Tripartite Pleasure Inventory [ Time Frame: 4-week follow-up ]
    Adolescent reported reward responsiveness

  18. Tripartite Pleasure Inventory [ Time Frame: 12-week follow-up ]
    Adolescent reported reward responsiveness

  19. Reward Probability Index [ Time Frame: After the 8-week preventive intervention ]
    Measure of adolescent reported environmental reward

  20. Reward Probability Index [ Time Frame: 4-week follow-up ]
    Measure of adolescent reported environmental reward

  21. Reward Probability Index [ Time Frame: 12-week follow-up ]
    Measure of adolescent reported environmental reward

  22. Behavioral Activation for Depression Scale [ Time Frame: After the 8-week preventive intervention ]
    Adolescent reported measure of behavioral activation and avoidance

  23. Behavioral Activation for Depression Scale [ Time Frame: 4-week follow-up ]
    Adolescent reported measure of behavioral activation and avoidance

  24. Behavioral Activation for Depression Scale [ Time Frame: 12-week follow-up ]
    Adolescent reported measure of behavioral activation and avoidance

  25. Balloon Analog Risk Task [ Time Frame: After the 8-week preventive intervention ]
    Positive reinforcement

  26. Balloon Analog Risk Task [ Time Frame: 4-week follow-up ]
    Positive reinforcement

  27. Balloon Analog Risk Task [ Time Frame: 12-week follow-up ]
    Positive reinforcement

  28. Impairment Rating Scale [ Time Frame: After the 8-week preventive intervention ]
    Parent- and teacher- report of global impairment

  29. Impairment Rating Scale [ Time Frame: 4-week follow-up ]
    Parent- and teacher- report of global impairment

  30. Impairment Rating Scale [ Time Frame: 12-week follow-up ]
    Parent- and teacher- report of global impairment



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104841


Contacts
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Contact: Andrea Chronis-Tuscano, PhD 301-405-9640 achronis@umd.edu

Locations
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United States, Maryland
University of Maryland Recruiting
College Park, Maryland, United States, 20742
Contact: Joseph Smith    301-405-0678    jsmith54@umd.edu   
Principal Investigator: Michael C Meinzer, PhD         
Principal Investigator: Andrea Chronis-Tuscano, PhD         
Sponsors and Collaborators
University of Maryland, College Park
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Michael Meinzer, PhD University of Maryland, College Park
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Responsible Party: University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT04104841    
Other Study ID Numbers: MH117086
R34MH117086 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Attention Deficit Disorder with Hyperactivity
Behavioral Symptoms
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders