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Video-visit Behavior Therapy for Anxiety and Depression in Youth

Primary Purpose

Anxiety, Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Behavioral Therapy
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Child, Adolescent

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Kaiser Permanente Northwest Center for Health Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STEP-UP (brief behavioral therapy)

Arm Description

Intervention arm of open trial

Outcomes

Primary Outcome Measures

Minimum attendance
Receipt of a minimum dose of intervention
Client Satisfaction Scale - Parent (CSQ-8-P)
Parent ratings of satisfaction with the intervention
Client Satisfaction Scale - Child (CSQ-8-C)
Child ratings of satisfaction with the intervention
Participant Acceptability Questionnaire - Parent (PAQ-P)
Parent ratings of the acceptability of the intervention and study procedures
Participant Acceptability Questionnaire - Child (PAQ-C)
Child ratings of the acceptability of the intervention and study procedures

Secondary Outcome Measures

Screen for Child Anxiety and Related Disorders - Parent (SCARED-P)
Parent-report of child anxiety symptoms
Screen for Child Anxiety and Related Disorders - Child (SCARED-C)
Child self-report of anxiety symptoms
Mood and Feelings Questionnaire - Parent (MFQ-P)
Parent-report of child depression symptoms
Mood and Feelings Questionnaire - Child (MFQ-C)
Child self-report of depression symptoms
Symptom Impairment Scale - Parent (SIS-P)
Parent rating of child impairment from symptoms of anxiety and depression
Symptom Impairment Scale - Child (SIS-C)
Child rating of impairment from symptoms of anxiety and depression
Child Avoidance Measure - Parent (CAMP)
Parent rating of child avoidance behaviors
Child Avoidance Measure - Child (CAMP)
Child rating of avoidance behaviors

Full Information

First Posted
June 9, 2022
Last Updated
June 9, 2022
Sponsor
San Diego State University
Collaborators
Kaiser Permanente, OCHIN, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05417412
Brief Title
Video-visit Behavior Therapy for Anxiety and Depression in Youth
Official Title
Video-visit Behavior Therapy for Anxiety and Depression in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
Kaiser Permanente, OCHIN, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Child, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEP-UP (brief behavioral therapy)
Arm Type
Experimental
Arm Description
Intervention arm of open trial
Intervention Type
Behavioral
Intervention Name(s)
Brief Behavioral Therapy
Other Intervention Name(s)
STEP-UP, BBT
Intervention Description
8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff at participating community health centers (CHCs)
Primary Outcome Measure Information:
Title
Minimum attendance
Description
Receipt of a minimum dose of intervention
Time Frame
Week 16 (post-intervention)
Title
Client Satisfaction Scale - Parent (CSQ-8-P)
Description
Parent ratings of satisfaction with the intervention
Time Frame
Week 16 (post-intervention)
Title
Client Satisfaction Scale - Child (CSQ-8-C)
Description
Child ratings of satisfaction with the intervention
Time Frame
Week 16 (post-intervention)
Title
Participant Acceptability Questionnaire - Parent (PAQ-P)
Description
Parent ratings of the acceptability of the intervention and study procedures
Time Frame
Week 16 (post-intervention)
Title
Participant Acceptability Questionnaire - Child (PAQ-C)
Description
Child ratings of the acceptability of the intervention and study procedures
Time Frame
Week 16 (post-intervention)
Secondary Outcome Measure Information:
Title
Screen for Child Anxiety and Related Disorders - Parent (SCARED-P)
Description
Parent-report of child anxiety symptoms
Time Frame
Week 16 (post-intervention)
Title
Screen for Child Anxiety and Related Disorders - Child (SCARED-C)
Description
Child self-report of anxiety symptoms
Time Frame
Week 16 (post-intervention)
Title
Mood and Feelings Questionnaire - Parent (MFQ-P)
Description
Parent-report of child depression symptoms
Time Frame
Week 16 (post-intervention)
Title
Mood and Feelings Questionnaire - Child (MFQ-C)
Description
Child self-report of depression symptoms
Time Frame
Week 16 (post-intervention)
Title
Symptom Impairment Scale - Parent (SIS-P)
Description
Parent rating of child impairment from symptoms of anxiety and depression
Time Frame
Week 16 (post-intervention)
Title
Symptom Impairment Scale - Child (SIS-C)
Description
Child rating of impairment from symptoms of anxiety and depression
Time Frame
Week 16 (post-intervention)
Title
Child Avoidance Measure - Parent (CAMP)
Description
Parent rating of child avoidance behaviors
Time Frame
Week 16 (post-intervention)
Title
Child Avoidance Measure - Child (CAMP)
Description
Child rating of avoidance behaviors
Time Frame
Week 16 (post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Kaiser Permanente Northwest Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
NIH data archive as appropriate

Learn more about this trial

Video-visit Behavior Therapy for Anxiety and Depression in Youth

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