Video-visit Behavior Therapy for Anxiety and Depression in Youth

• Sponsor: San Diego State University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05417412
• Collaborator: Kaiser Permanente (Other), OCHIN, Inc. (Other)
• Enrollment: 14
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23.9
• Patients Per Site Per Month: 0.6

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Depression	Behavioral: Brief Behavioral Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Video-visit Behavior Therapy for Anxiety and Depression in Youth
• Actual Study Start Date: Aug 2, 2021
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Jul 30, 2023

Arms and Interventions

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: STEP-UP BBT

Outcome Measures

Primary Outcome Measures

1. Minimum attendance [Week 16 (post-intervention)]

   Receipt of a minimum dose of intervention

2. Client Satisfaction Scale - Parent (CSQ-8-P) [Week 16 (post-intervention)]

   Parent ratings of satisfaction with the intervention

3. Client Satisfaction Scale - Child (CSQ-8-C) [Week 16 (post-intervention)]

   Child ratings of satisfaction with the intervention

4. Participant Acceptability Questionnaire - Parent (PAQ-P) [Week 16 (post-intervention)]

   Parent ratings of the acceptability of the intervention and study procedures

5. Participant Acceptability Questionnaire - Child (PAQ-C) [Week 16 (post-intervention)]

   Child ratings of the acceptability of the intervention and study procedures

Secondary Outcome Measures

1. Screen for Child Anxiety and Related Disorders - Parent (SCARED-P) [Week 16 (post-intervention)]

   Parent-report of child anxiety symptoms

2. Screen for Child Anxiety and Related Disorders - Child (SCARED-C) [Week 16 (post-intervention)]

   Child self-report of anxiety symptoms

3. Mood and Feelings Questionnaire - Parent (MFQ-P) [Week 16 (post-intervention)]

   Parent-report of child depression symptoms

4. Mood and Feelings Questionnaire - Child (MFQ-C) [Week 16 (post-intervention)]

   Child self-report of depression symptoms

5. Symptom Impairment Scale - Parent (SIS-P) [Week 16 (post-intervention)]

   Parent rating of child impairment from symptoms of anxiety and depression

6. Symptom Impairment Scale - Child (SIS-C) [Week 16 (post-intervention)]

   Child rating of impairment from symptoms of anxiety and depression

7. Child Avoidance Measure - Parent (CAMP) [Week 16 (post-intervention)]

   Parent rating of child avoidance behaviors

8. Child Avoidance Measure - Child (CAMP) [Week 16 (post-intervention)]

   Child rating of avoidance behaviors

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Northwest Center for Health Research	Portland	Oregon	United States	97227

Sponsors and Collaborators

• San Diego State University
• Kaiser Permanente
• OCHIN, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: V. Robin Weersing, Professor, San Diego State University
• ClinicalTrials.gov Identifier: NCT05417412
• Other Study ID Numbers: R56MH125159
• First Posted: Jun 14, 2022
• Last Update Posted: Jun 14, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by V. Robin Weersing, Professor, San Diego State University: Child; Adolescent
• Additional relevant MeSH terms: Depression; Depressive Disorder; Anxiety Disorders

Study Results

No Results Posted as of Jun 14, 2022