Video-visit Behavior Therapy for Anxiety and Depression in Youth

NCT05417412 | Completed Results

• 1 other identifier: R56MH125159
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety; Depression

Keywords

Child; Adolescent

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Screen for Child Anxiety and Related Disorders - Parent (SCARED-P)

  Week 16 (post-intervention)

• Screen for Child Anxiety and Related Disorders - Child (SCARED-C)

  Week 16 (post-intervention)

• Mood and Feelings Questionnaire - Parent (MFQ-P)

  Week 16 (post-intervention)

• Mood and Feelings Questionnaire - Child (MFQ-C)

  Week 16 (post-intervention)

• Symptom Impairment Scale - Parent (SIS-P)

  Week 16 (post-intervention)

Study Arms (1)

STEP-UP (brief behavioral therapy)

EXPERIMENTAL

Intervention arm of open trial

Behavioral: Brief Behavioral Therapy

Interventions

Brief Behavioral Therapy BEHAVIORAL

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

Also known as: STEP-UP, BBT

STEP-UP (brief behavioral therapy)

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

This pilot study was designed and funded prior to the COVID-19 pandemic; however, all enrollment of participants and delivery of intervention occurred after the start of the pandemic. The study was based in primary care, and the STEP-UP treatment was provided by clinical staff as part of their regular responsibilities. Results should be interpreted in this historical context of heavy demand on health care providers and facilities.

Results Point of Contact

• Title: Dr. V. Robin Weersing
• Organization: San Diego State University

robin.weersing@sdsu.edu

619-594-8892

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: August 2, 2021
• Primary Completion: August 30, 2022
• Study Completion: July 30, 2023
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)