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
• Secondary ID: R56MH125159
• Status: Completed
• Phase: N/A
• Start date: August 2, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: May 2024
• 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 (4)

Lead Sponsor	Collaborator
San Diego State University	Kaiser Permanente, National Institute of Mental Health (NIMH), 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. A minimum dose was defined as 8 or more sessions of the intervention.	Week 16 (post-intervention)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)