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Completed

NCT Number: NCT05417412

Video-visit Behavior Therapy for Anxiety and Depression in Youth

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).

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, 97227, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Brief behavioral therapy

Behavioral

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

Primary outcomes

  1. Minimum Attendance

    Time frame: Week 16 (post-intervention)

    Receipt of a minimum dose of intervention. A minimum dose was defined as 8 or more sessions of the intervention.

  2. Client Satisfaction Scale - Parent (CSQ-8-P)

    Time frame: Week 16 (post-intervention)

    Parent ratings of satisfaction with the intervention. Ratings of "mostly" or "very" satisfied were coded as "satisfied." All other ratings were coded as "unsatisfied."

  3. Client Satisfaction Scale - Child (CSQ-8-C)

    Time frame: Week 16 (post-intervention)

    Youth ratings of satisfaction with the intervention. Ratings of "mostly" or "very" satisfied were coded as "satisfied." All other ratings were coded as "unsatisfied."

  4. Participant Acceptability Questionnaire - Parent (PAQ-P)

    Time frame: Week 16 (post-intervention)

    Parent ratings of the acceptability of the telehealth intervention. Responses were classified as "little or no technical problems" or "technical difficulties."

  5. Participant Acceptability Questionnaire - Child (PAQ-C)

    Time frame: Week 16 (post-intervention)

    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."

Secondary outcomes

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

    Time frame: Week 16 (post-intervention)

    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.

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

    Time frame: Week 16 (post-intervention)

    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.

  3. Mood and Feelings Questionnaire - Parent (MFQ-P)

    Time frame: Week 16 (post-intervention)

    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.

  4. Mood and Feelings Questionnaire - Child (MFQ-C)

    Time frame: Week 16 (post-intervention)

    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.

  5. Symptom Impairment Scale - Parent (SIS-P)

    Time frame: Week 16 (post-intervention)

    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.

  6. Symptom Impairment Scale - Child (SIS-C)

    Time frame: Week 16 (post-intervention)

    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.

  7. Child Avoidance Measure - Parent (CAMP)

    Time frame: Week 16 (post-intervention)

    Parent rating of youth avoidance behaviors due to anxiety. Scores range from 0 to 24, and higher scores indicate greater avoidance.

  8. Child Avoidance Measure - Child (CAMP)

    Time frame: Week 16 (post-intervention)

    Youth self-report rating of avoidance behaviors due to anxiety. Scores range from 0 to 24, and higher scores indicate greater avoidance.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • Kaiser Permanente
  • National Institute of Mental Health (NIMH)
  • OCHIN, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 14, 2022
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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