NCT04104841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2022

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

September 24, 2019

Last Update Submit

December 20, 2023

Conditions

Attention Deficit Hyperactivity DisorderDepressive Symptoms

Outcome Measures

Primary Outcomes (3)

  • Children's Depression Inventory, 2nd Edition (CDI-2)

    Adolescent and parent reported depressive symptoms

    After the 8-week preventive intervention

  • Children's Depression Inventory, 2nd Edition (CDI-2)

    Adolescent and parent reported depressive symptoms

    4-week follow-up

  • Children's Depression Inventory, 2nd Edition (CDI-2)

    Adolescent and parent reported depressive symptoms

    12-week follow-up

Secondary Outcomes (30)

  • Affective Reactivity Index

    After the 8-week preventive intervention

  • Affective Reactivity Index

    4-week follow-up

  • Affective Reactivity Index

    12-week follow-up

  • Suicide Behavior Questionnaire

    After the 8-week preventive intervention

  • Suicide Behavior Questionnaire

    4-week follow-up

  • +25 more secondary outcomes

Study Arms (2)

Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS)

EXPERIMENTAL

8-session modified behavioral activation program

Behavioral: Behaviorally Enhancing Adolescents' Mood in Schools

Usual Care

ACTIVE COMPARATOR

Referrals to usual care

Behavioral: Usual Care

Interventions

Behaviorally Enhancing Adolescents' Mood in SchoolsBEHAVIORAL

8-session modified behavioral activation intervention

Behaviorally Enhancing Adolescents' Mood in Schools (BEAMS)
Usual CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

College Park, Maryland, 20742, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDepression

Interventions

Schools

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

  • Michael Meinzer, PhD

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

August 7, 2018

Primary Completion

July 1, 2021

Study Completion

July 11, 2022

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

US(1)