Video-visit Behavior Therapy for Anxiety and Depression in Youth

NCT ID: NCT05417412

Last Updated: 2024-05-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-02

Study Completion Date

2023-07-30

Brief Summary

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This project focuses on adapting and pilot testing an efficacious brief behavioral therapy (STEP-UP) for youths with anxiety or depression to be delivered as a telehealth intervention by clinic staff in low-resource community health centers (CHCs).

Detailed Description

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Conditions

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Anxiety Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STEP-UP (brief behavioral therapy)

Intervention arm of open trial

Group Type EXPERIMENTAL

Brief Behavioral Therapy

Intervention Type BEHAVIORAL

8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff at participating community health centers (CHCs)

Interventions

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Brief Behavioral Therapy

8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff at participating community health centers (CHCs)

Intervention Type BEHAVIORAL

Other Intervention Names

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STEP-UP BBT

Eligibility Criteria

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Inclusion Criteria

* Youth is a patient at a participating community health center (CHC) site
* Youth is clinically referred by a provider and / or has anxiety and / or depression as a diagnosis or target problem in their medical record
* Youth is in the physical and legal custody of the caretaker and is not currently involved in the foster care system
* Youth is able and willing to conduct study assessments and intervention sessions in English
* Primary caretaker is able and willing to conduct study assessments and intervention sessions in English or in Spanish
* Youth is functioning at or above the academic level of a typical 8-year-old child (i.e., placed in at least the second-grade level school across all subjects in a general education classroom)
* Primary caretaker agrees that focusing on anxiety and / or depression would be a useful primary target for treatment
* Youth has clinically significant symptoms of anxiety and / or depression by youth or caretaker report

Exclusion Criteria

* Youth is receiving an alternate intervention for anxiety or depression
* Youth or parent reports that the youth is experiencing active suicidal ideation with plan or intent (i.e., within last three months) and / or has made a suicide attempt within the last six months
* Youth or parent reports that the youth is currently engaging in non-suicidal self-injury (i.e., within last three months)
* Youth or parent reports that the youth has experienced recent physical or sexual abuse (i.e., within last three months).
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

OCHIN, Inc.

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

San Diego State University

OTHER

Sponsor Role lead

Responsible Party

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V. Robin Weersing

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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R56MH125159

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R56MH125159

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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