Clinical trial NCT05417412: Video-visit Behavior Therapy for Anxiety and Depression in Youth
Official title: Video-visit Behavior Therapy for Anxiety and Depression in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: Child
Adolescent
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: OCHIN, Inc.
name: National Institute of Mental Health (NIMH)
First posted: 2022-06-14
Enrollment: 12
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Minimum Attendance
timeFrame: Week 16 (post-intervention)
measure: Client Satisfaction Scale - Parent (CSQ-8-P)
timeFrame: Week 16 (post-intervention)
measure: Client Satisfaction Scale - Child (CSQ-8-C)
timeFrame: Week 16 (post-intervention)
measure: Participant Acceptability Questionnaire - Parent (PAQ-P)
timeFrame: Week 16 (post-intervention)
measure: Participant Acceptability Questionnaire - Child (PAQ-C)
timeFrame: Week 16 (post-intervention)
Secondary outcomes:
measure: Screen for Child Anxiety and Related Disorders - Parent (SCARED-P)
timeFrame: Week 16 (post-intervention)
measure: Screen for Child Anxiety and Related Disorders - Child (SCARED-C)
timeFrame: Week 16 (post-intervention)
measure: Mood and Feelings Questionnaire - Parent (MFQ-P)
timeFrame: Week 16 (post-intervention)
measure: Mood and Feelings Questionnaire - Child (MFQ-C)
timeFrame: Week 16 (post-intervention)
measure: Symptom Impairment Scale - Parent (SIS-P)
timeFrame: Week 16 (post-intervention)
measure: Symptom Impairment Scale - Child (SIS-C)
timeFrame: Week 16 (post-intervention)
measure: Child Avoidance Measure - Parent (CAMP)
timeFrame: Week 16 (post-intervention)
measure: Child Avoidance Measure - Child (CAMP)
timeFrame: Week 16 (post-intervention)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Northwest Center for Health Research
state: Oregon
Study officials:
References: