Video-visit Behavior Therapy for Anxiety and Depression in Youth

Depression Clinical Trial

Official title:

Video-visit Behavior Therapy for Anxiety and Depression in Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05417412
• Other study ID #: R56MH125159
• Status: Completed
• Phase: N/A
• Start date: August 2, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: December 2023
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 30, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente Northwest Center for Health Research	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
San Diego State University	Kaiser Permanente, OCHIN, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum attendance	Receipt of a minimum dose of intervention	Week 16 (post-intervention)
Primary	Client Satisfaction Scale - Parent (CSQ-8-P)	Parent ratings of satisfaction with the intervention	Week 16 (post-intervention)
Primary	Client Satisfaction Scale - Child (CSQ-8-C)	Child ratings of satisfaction with the intervention	Week 16 (post-intervention)
Primary	Participant Acceptability Questionnaire - Parent (PAQ-P)	Parent ratings of the acceptability of the intervention and study procedures	Week 16 (post-intervention)
Primary	Participant Acceptability Questionnaire - Child (PAQ-C)	Child ratings of the acceptability of the intervention and study procedures	Week 16 (post-intervention)
Secondary	Screen for Child Anxiety and Related Disorders - Parent (SCARED-P)	Parent-report of child anxiety symptoms	Week 16 (post-intervention)
Secondary	Screen for Child Anxiety and Related Disorders - Child (SCARED-C)	Child self-report of anxiety symptoms	Week 16 (post-intervention)
Secondary	Mood and Feelings Questionnaire - Parent (MFQ-P)	Parent-report of child depression symptoms	Week 16 (post-intervention)
Secondary	Mood and Feelings Questionnaire - Child (MFQ-C)	Child self-report of depression symptoms	Week 16 (post-intervention)
Secondary	Symptom Impairment Scale - Parent (SIS-P)	Parent rating of child impairment from symptoms of anxiety and depression	Week 16 (post-intervention)
Secondary	Symptom Impairment Scale - Child (SIS-C)	Child rating of impairment from symptoms of anxiety and depression	Week 16 (post-intervention)
Secondary	Child Avoidance Measure - Parent (CAMP)	Parent rating of child avoidance behaviors	Week 16 (post-intervention)
Secondary	Child Avoidance Measure - Child (CAMP)	Child rating of avoidance behaviors	Week 16 (post-intervention)