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Completed

NCT Number: NCT04104841

School-Based Depression Prevention for Adolescents With ADHD

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.

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland

College Park, Maryland, 20742, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behaviorally Enhancing Adolescents' Mood in Schools

Behavioral

8-session modified behavioral activation intervention

Usual Care

Behavioral

Referral to school mental health provider, social worker, or community care.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: BEAMS

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 26, 2019
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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