University of Maryland
College Park, Maryland, 20742, United States
NCT Number: NCT04104841
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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Notify Me14 year–18 year
All sexes
Interventional
Not applicable
College Park, Maryland, 20742, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8-session modified behavioral activation intervention
Referral to school mental health provider, social worker, or community care.
Time frame: After the 8-week preventive intervention
Adolescent and parent reported depressive symptoms
Time frame: 4-week follow-up
Adolescent and parent reported depressive symptoms
Time frame: 12-week follow-up
Adolescent and parent reported depressive symptoms
Time frame: After the 8-week preventive intervention
Adolescent and parent reported irritability
Time frame: 4-week follow-up
Adolescent and parent reported irritability
Time frame: 12-week follow-up
Adolescent and parent reported irritability
Time frame: After the 8-week preventive intervention
Adolescent reported suicidal thoughts and behaviors
Time frame: 4-week follow-up
Adolescent reported suicidal thoughts and behaviors
Time frame: 12-week follow-up
Adolescent reported suicidal thoughts and behaviors
Time frame: After the 8-week preventive intervention
Parent reported emotion dysregulation
Time frame: 4-week follow-up
Parent reported emotion dysregulation
Time frame: 12-week follow-up
Parent reported emotion dysregulation
Time frame: After the 8-week preventive intervention
Adolescent reported emotion dysregulation
Time frame: 4-week follow-up
Adolescent reported emotion dysregulation
Time frame: 12-week follow-up
Adolescent reported emotion dysregulation
Time frame: After the 8-week preventive intervention
Emotion regulation behavioral task
Time frame: 4-week follow-up
Emotion regulation behavioral task
Time frame: 12-week follow-up
Emotion regulation behavioral task
Time frame: After the 8-week preventive intervention
Adolescent reported reward responsiveness
Time frame: 4-week follow-up
Adolescent reported reward responsiveness
Time frame: 12-week follow-up
Adolescent reported reward responsiveness
Time frame: After the 8-week preventive intervention
Measure of adolescent reported environmental reward
Time frame: 4-week follow-up
Measure of adolescent reported environmental reward
Time frame: 12-week follow-up
Measure of adolescent reported environmental reward
Time frame: After the 8-week preventive intervention
Adolescent reported measure of behavioral activation and avoidance
Time frame: 4-week follow-up
Adolescent reported measure of behavioral activation and avoidance
Time frame: 12-week follow-up
Adolescent reported measure of behavioral activation and avoidance
Time frame: After the 8-week preventive intervention
Positive reinforcement
Time frame: 4-week follow-up
Positive reinforcement
Time frame: 12-week follow-up
Positive reinforcement
Time frame: After the 8-week preventive intervention
Parent- and teacher- report of global impairment
Time frame: 4-week follow-up
Parent- and teacher- report of global impairment
Time frame: 12-week follow-up
Parent- and teacher- report of global impairment
University of Maryland, College Park
Other
Acronym: BEAMS
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