Video-visit Behavior Therapy for Anxiety and Depression in Youth

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).

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Brief Behavioral Therapy

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Northwest Center for Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STEP-UP (brief behavioral therapy); Intervention arm of open trial	Behavioral: Brief Behavioral Therapy; 8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff at participating community health centers (CHCs); Other Names: BBT; STEP-UP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum Attendance	Receipt of a minimum dose of intervention. A minimum dose was defined as 8 or more sessions of the intervention.	Week 16 (post-intervention)
Client Satisfaction Scale - Parent (CSQ-8-P)	Parent ratings of satisfaction with the intervention. Ratings of "mostly" or "very" satisfied were coded as "satisfied." All other ratings were coded as "unsatisfied."	Week 16 (post-intervention)
Client Satisfaction Scale - Child (CSQ-8-C)	Youth ratings of satisfaction with the intervention. Ratings of "mostly" or "very" satisfied were coded as "satisfied." All other ratings were coded as "unsatisfied."	Week 16 (post-intervention)
Participant Acceptability Questionnaire - Parent (PAQ-P)	Parent ratings of the acceptability of the telehealth intervention. Responses were classified as "little or no technical problems" or "technical difficulties."	Week 16 (post-intervention)
Participant Acceptability Questionnaire - Child (PAQ-C)	Youth ratings of the acceptability of the intervention. Youths were asked whether they would recommend the intervention to a friend. Responses were included "would recommend" and "unlikely."	Week 16 (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen for Child Anxiety and Related Disorders - Parent (SCARED-P)	Total score on the Screen for Anxiety and Related Disorders scale (parent report on youth), a dimensional measure of anxiety symptoms. Scores range from 0 to 82, and higher scores indicate greater symptom severity. Scores >= 25 may indicate the presence of an anxiety disorder.	Week 16 (post-intervention)
Screen for Child Anxiety and Related Disorders - Child (SCARED-C)	Total score on the Screen for Anxiety and Related Disorders scale (youth report on self), a dimensional measure of anxiety symptoms. Scores range from 0 to 82, and higher scores indicate greater symptom severity. Scores >= 25 may indicate the presence of an anxiety disorder.	Week 16 (post-intervention)
Mood and Feelings Questionnaire - Parent (MFQ-P)	Total score on the Mood and Feelings Questionnaire - parent report on youth (MFQ-P) a dimensional measure of depression symptoms. Scores range from 0 to 68, and higher scores indicate greater depression symptom severity.	Week 16 (post-intervention)
Mood and Feelings Questionnaire - Child (MFQ-C)	Total score on the Mood and Feelings Questionnaire (youth report on self) a dimensional measure of depression symptoms. Higher scores indicate greater symptom severity. Scores range from 0 to 66, and higher scores indicate greater depression symptom severity.	Week 16 (post-intervention)
Symptom Impairment Scale - Parent (SIS-P)	Parent rating of child impairment in school, social, and family domains from symptoms of anxiety (3 questions) and depression (3 questions). Higher scores indicate greater levels of perceived impairment. Individual questions scores range from zero (not at all impairing) to three (very much impairing), and the total score ranges from 0 to 18.	Week 16 (post-intervention)
Symptom Impairment Scale - Child (SIS-C)	Youth self-rating of impairment in school, social, and family domains from symptoms of anxiety (3 questions) and depression (3 questions). Higher scores indicate greater levels of perceived impairment. Individual questions scores range from zero (not at all impairing) to three (very much impairing), and the total score ranges from 0 to 18.	Week 16 (post-intervention)
Child Avoidance Measure - Parent (CAMP)	Parent rating of youth avoidance behaviors due to anxiety. Scores range from 0 to 24, and higher scores indicate greater avoidance.	Week 16 (post-intervention)
Child Avoidance Measure - Child (CAMP)	Youth self-report rating of avoidance behaviors due to anxiety. Scores range from 0 to 24, and higher scores indicate greater avoidance.	Week 16 (post-intervention)

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: National Institute of Mental Health (NIMH); Kaiser Permanente; OCHIN, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Adolescent; Child
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: R56MH125159 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: NIH data archive as appropriate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No