Clinical trial NCT04104841: School-Based Depression Prevention for Adolescents With ADHD
Official title: School-Based Depression Prevention for Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Depressive Symptoms
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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).

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

Primary outcomes:
measure: Children's Depression Inventory, 2nd Edition (CDI-2)
timeFrame: After the 8-week preventive intervention
measure: Children's Depression Inventory, 2nd Edition (CDI-2)
timeFrame: 4-week follow-up
measure: Children's Depression Inventory, 2nd Edition (CDI-2)
timeFrame: 12-week follow-up
Secondary outcomes:
measure: Affective Reactivity Index
timeFrame: After the 8-week preventive intervention
measure: Affective Reactivity Index
timeFrame: 4-week follow-up
measure: Affective Reactivity Index
timeFrame: 12-week follow-up
measure: Suicide Behavior Questionnaire
timeFrame: After the 8-week preventive intervention
measure: Suicide Behavior Questionnaire
timeFrame: 4-week follow-up
measure: Suicide Behavior Questionnaire
timeFrame: 12-week follow-up
measure: Emotion Regulation Checklist
timeFrame: After the 8-week preventive intervention
measure: Emotion Regulation Checklist
timeFrame: 4-week follow-up
measure: Emotion Regulation Checklist
timeFrame: 12-week follow-up
measure: Difficulties in Emotion Regulation
timeFrame: After the 8-week preventive intervention
measure: Difficulties in Emotion Regulation
timeFrame: 4-week follow-up
measure: Difficulties in Emotion Regulation
timeFrame: 12-week follow-up
measure: Mirror Tracing Persistence Task
timeFrame: After the 8-week preventive intervention
measure: Mirror Tracing Persistence Task
timeFrame: 4-week follow-up
measure: Mirror Tracing Persistence Task
timeFrame: 12-week follow-up
measure: Tripartite Pleasure Inventory
timeFrame: After the 8-week preventive intervention
measure: Tripartite Pleasure Inventory
timeFrame: 4-week follow-up
measure: Tripartite Pleasure Inventory
timeFrame: 12-week follow-up
measure: Reward Probability Index
timeFrame: After the 8-week preventive intervention
measure: Reward Probability Index
timeFrame: 4-week follow-up
measure: Reward Probability Index
timeFrame: 12-week follow-up
measure: Behavioral Activation for Depression Scale
timeFrame: After the 8-week preventive intervention
measure: Behavioral Activation for Depression Scale
timeFrame: 4-week follow-up
measure: Behavioral Activation for Depression Scale
timeFrame: 12-week follow-up
measure: Balloon Analog Risk Task
timeFrame: After the 8-week preventive intervention
measure: Balloon Analog Risk Task
timeFrame: 4-week follow-up
measure: Balloon Analog Risk Task
timeFrame: 12-week follow-up
measure: Impairment Rating Scale
timeFrame: After the 8-week preventive intervention
measure: Impairment Rating Scale
timeFrame: 4-week follow-up
measure: Impairment Rating Scale
timeFrame: 12-week follow-up
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Michael Meinzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: