AnxietyNCT05417412

Video-visit Behavior Therapy for Anxiety and Depression in Youth

A study testing Brief Behavioral Therapy in people with Anxiety and Depression, run by San Diego State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 8 to 17 years
Conditions the study is for: Anxiety, Depression
What is being tested?: Brief Behavioral Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 2 Aug 2021to 30 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente Northwest Center for Health Research
Portland, Oregon, 97227

Other trials in United States

About this study

Conditions: Anxiety, Depression
Being tested: Brief Behavioral Therapy
Keywords: Child, Adolescent
Medical subject headings: Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brief Behavioral TherapyBehavioural
Also called STEP-UP, BBT
8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff at participating community health centers (CHCs)

Study groups in NCT05417412
Study group	Role	What they receive
STEP-UP (brief behavioral therapy)	Experimental	Intervention arm of open trial Receives: Behavioral: Brief Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Minimum Attendance
Receipt of a minimum dose of intervention. A minimum dose was defined as 8 or more sessions of the intervention.
Measured: Week 16 (post-intervention)
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."
Measured: Week 16 (post-intervention)
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."
Measured: Week 16 (post-intervention)
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."
Measured: Week 16 (post-intervention)
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."
Measured: Week 16 (post-intervention)

Secondary outcomes (8)

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.
Measured: Week 16 (post-intervention)
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.
Measured: Week 16 (post-intervention)
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.
Measured: Week 16 (post-intervention)
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.
Measured: Week 16 (post-intervention)
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.
Measured: Week 16 (post-intervention)
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.
Measured: Week 16 (post-intervention)
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.
Measured: Week 16 (post-intervention)
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.
Measured: Week 16 (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 202130 Jul 2023

First posted14 Jun 2022
Study start2 Aug 2021
Primary completion30 Aug 2022
Study completion30 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by San Diego State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05417412
Sponsor's protocol ID: R56MH125159
Other IDs: R56MH125159
Status last verified: May 2024
First submitted: 9 Jun 2022
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Video-visit Behavior Therapy for Anxiety and Depression in Youth
ClinicalTrials.gov ID: NCT05417412
Acronym / sponsor ID: R56MH125159
Conditions: Anxiety, Depression
Keywords: Child, Adolescent
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: San Diego State UniversityUniversity, hospital or other
Collaborators: Kaiser Permanente, OCHIN, Inc., National Institute of Mental Health (NIMH)
Study start: 2 Aug 2021 (actual)
Primary completion: 30 Aug 2022 (actual)
Study completion: 30 Jul 2023 (actual)
First posted: 14 Jun 2022 (actual)
Results: Posted 16 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
STEP-UP (brief behavioral therapy)	Experimental	Behavioral: Brief Behavioral TherapyIntervention arm of open trial

Who may qualify

Ages: 8 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

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

Key exclusion criteria (4 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brief Behavioral TherapyAlso: STEP-UP, BBT8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff at participating community health centers (CHCs)	Behavioural	STEP-UP (brief behavioral therapy)

Primary outcome

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.
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."
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."
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."
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."

8 secondary outcomes

Screen for Child Anxiety and Related Disorders - Parent (SCARED-P)
Time frame: Week 16 (post-intervention)
Screen for Child Anxiety and Related Disorders - Child (SCARED-C)
Time frame: Week 16 (post-intervention)
Mood and Feelings Questionnaire - Parent (MFQ-P)
Time frame: Week 16 (post-intervention)
Mood and Feelings Questionnaire - Child (MFQ-C)
Time frame: Week 16 (post-intervention)
Symptom Impairment Scale - Parent (SIS-P)
Time frame: Week 16 (post-intervention)
Symptom Impairment Scale - Child (SIS-C)
Time frame: Week 16 (post-intervention)
Child Avoidance Measure - Parent (CAMP)
Time frame: Week 16 (post-intervention)
Child Avoidance Measure - Child (CAMP)
Time frame: Week 16 (post-intervention)

Results and safety

Results posted to the registry on 16 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
STEP-UP (Brief Behavioral Therapy)	12	10

Primary outcome: Minimum Attendance

Time frame: Week 16 (post-intervention). Count of participants. Unit: Participants

Measure	STEP-UP (Brief Behavioral Therapy) n = 12
Attended less than 8 sessions	5
Attended 8 or more sessions	7

Population analysed: Receipt of a minimum dose of intervention was coded from electronic medical records for all 12 enrolled youths. Families who were lost to follow-up were included in these analyses.

Primary outcome: Client Satisfaction Scale - Parent (CSQ-8-P)

Time frame: Week 16 (post-intervention). Count of participants. Unit: Participants

Measure	STEP-UP (Brief Behavioral Therapy) n = 12
Satisfied	9
Unsatisfied	0
Unknown / lost to follow-up	3

Primary outcome: Client Satisfaction Scale - Child (CSQ-8-C)

Time frame: Week 16 (post-intervention). Count of participants. Unit: Participants

Measure	STEP-UP (Brief Behavioral Therapy) n = 12
Satisfied	10
Unsatisfied	0
Unknown / lost to follow-up	2

Primary outcome: Participant Acceptability Questionnaire - Parent (PAQ-P)

Time frame: Week 16 (post-intervention). Count of participants. Unit: Participants

Measure	STEP-UP (Brief Behavioral Therapy) n = 12
Little to no technical problems	6
Technical difficulties	3
Unknown / lost to follow up	3

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data collected from baseline (Week 0) through follow-up (Week 16). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
STEP-UP (Brief Behavioral Therapy)	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): This pilot study was designed and funded prior to the COVID-19 pandemic; however, all enrollment of participants and delivery of intervention occurred after the start of the pandemic. The study was based in primary care, and the STEP-UP treatment was provided by clinical staff as part of their regular responsibilities. Results should be interpreted in this historical context of heavy demand on health care providers and facilities.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Brief Behavioral Therapy in people with Anxiety and Depression, run by San Diego State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimum Attendance (time frame: Week 16 (post-intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05417412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.