School-Based Depression Prevention for Adolescents With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

— BEAMS  

Official title:

School-Based Depression Prevention for Adolescents With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104841
• Other study ID #: MH117086
• Secondary ID: R34MH117086
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: July 11, 2022

Study information

• Verified date: December 2023
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Subsequently the investigators will examine its effectiveness in reducing depressive symptoms and improving emotion regulation and reward responsivity, compared to usual care.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 11, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Behaviorally Enhancing Adolescents' Mood in Schools
8-session modified behavioral activation intervention
• Usual Care
Referral to school mental health provider, social worker, or community care.

Locations

Country	Name	City	State
United States	University of Maryland	College Park	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, College Park	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Depression Inventory, 2nd Edition (CDI-2)	Adolescent and parent reported depressive symptoms	After the 8-week preventive intervention
Primary	Children's Depression Inventory, 2nd Edition (CDI-2)	Adolescent and parent reported depressive symptoms	4-week follow-up
Primary	Children's Depression Inventory, 2nd Edition (CDI-2)	Adolescent and parent reported depressive symptoms	12-week follow-up
Secondary	Affective Reactivity Index	Adolescent and parent reported irritability	After the 8-week preventive intervention
Secondary	Affective Reactivity Index	Adolescent and parent reported irritability	4-week follow-up
Secondary	Affective Reactivity Index	Adolescent and parent reported irritability	12-week follow-up
Secondary	Suicide Behavior Questionnaire	Adolescent reported suicidal thoughts and behaviors	After the 8-week preventive intervention
Secondary	Suicide Behavior Questionnaire	Adolescent reported suicidal thoughts and behaviors	4-week follow-up
Secondary	Suicide Behavior Questionnaire	Adolescent reported suicidal thoughts and behaviors	12-week follow-up
Secondary	Emotion Regulation Checklist	Parent reported emotion dysregulation	After the 8-week preventive intervention
Secondary	Emotion Regulation Checklist	Parent reported emotion dysregulation	4-week follow-up
Secondary	Emotion Regulation Checklist	Parent reported emotion dysregulation	12-week follow-up
Secondary	Difficulties in Emotion Regulation	Adolescent reported emotion dysregulation	After the 8-week preventive intervention
Secondary	Difficulties in Emotion Regulation	Adolescent reported emotion dysregulation	4-week follow-up
Secondary	Difficulties in Emotion Regulation	Adolescent reported emotion dysregulation	12-week follow-up
Secondary	Mirror Tracing Persistence Task	Emotion regulation behavioral task	After the 8-week preventive intervention
Secondary	Mirror Tracing Persistence Task	Emotion regulation behavioral task	4-week follow-up
Secondary	Mirror Tracing Persistence Task	Emotion regulation behavioral task	12-week follow-up
Secondary	Tripartite Pleasure Inventory	Adolescent reported reward responsiveness	After the 8-week preventive intervention
Secondary	Tripartite Pleasure Inventory	Adolescent reported reward responsiveness	4-week follow-up
Secondary	Tripartite Pleasure Inventory	Adolescent reported reward responsiveness	12-week follow-up
Secondary	Reward Probability Index	Measure of adolescent reported environmental reward	After the 8-week preventive intervention
Secondary	Reward Probability Index	Measure of adolescent reported environmental reward	4-week follow-up
Secondary	Reward Probability Index	Measure of adolescent reported environmental reward	12-week follow-up
Secondary	Behavioral Activation for Depression Scale	Adolescent reported measure of behavioral activation and avoidance	After the 8-week preventive intervention
Secondary	Behavioral Activation for Depression Scale	Adolescent reported measure of behavioral activation and avoidance	4-week follow-up
Secondary	Behavioral Activation for Depression Scale	Adolescent reported measure of behavioral activation and avoidance	12-week follow-up
Secondary	Balloon Analog Risk Task	Positive reinforcement	After the 8-week preventive intervention
Secondary	Balloon Analog Risk Task	Positive reinforcement	4-week follow-up
Secondary	Balloon Analog Risk Task	Positive reinforcement	12-week follow-up
Secondary	Impairment Rating Scale	Parent- and teacher- report of global impairment	After the 8-week preventive intervention
Secondary	Impairment Rating Scale	Parent- and teacher- report of global impairment	4-week follow-up
Secondary	Impairment Rating Scale	Parent- and teacher- report of global impairment	12-week follow-up