Video-visit Behavior Therapy for Anxiety and Depression in Youth

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05417412

Enrollment

Registered

2022-06-14

Start date

2021-08-02

Completion date

2023-07-30

Last updated

2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Keywords

Child, Adolescent

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).

Interventions

BEHAVIORALBrief Behavioral Therapy

8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff at participating community health centers (CHCs)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 17 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Participant Acceptability Questionnaire - Child (PAQ-C)	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.
Minimum Attendance	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)	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)	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)	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.

Secondary

Measure	Time frame	Description
Symptom Impairment Scale - Child (SIS-C)	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.
Screen for Child Anxiety and Related Disorders - Parent (SCARED-P)	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.
Child Avoidance Measure - Child (CAMP)	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.
Child Avoidance Measure - Parent (CAMP)	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.
Screen for Child Anxiety and Related Disorders - Child (SCARED-C)	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.
Mood and Feelings Questionnaire - Parent (MFQ-P)	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.
Mood and Feelings Questionnaire - Child (MFQ-C)	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.
Symptom Impairment Scale - Parent (SIS-P)	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.

Countries

United States

Participant flow

Recruitment details

Youths were recruited from community health centers through electronic health record identification and clinician referral. Youth and their caregivers / guardians (parents) were mailed letters describing the study and giving them the opportunity to opt-out of research contact. Families that did not opt-out were called by research staff, screened for initial eligibility, and consented for participation.

Participants by arm

Arm	Count
STEP-UP (Brief Behavioral Therapy) Intervention arm of open trial Brief Behavioral Therapy: 8-12 sessions of brief behavioral therapy administered via telehealth by behavioral health / mental health staff at participating community health centers (CHCs). Youths were the target of treatment and were the enrolled participants in the clinical trial.	12
Total	12

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	2

Baseline characteristics

Characteristic	STEP-UP (Brief Behavioral Therapy)
Age, Categorical <=18 years	12 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Insurance status Medicaid / uninsured	9 Participants
Insurance status Private insurance	3 Participants
Mood and Feelings Questionnaire child report on self (MFQ-C)	21.83 units on a scale STANDARD_DEVIATION 11.28
Mood and Feelings Questionnaire - parent report on child (MFQ-P)	13.25 units on a scale STANDARD_DEVIATION 6.48
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants
Race (NIH/OMB) White	7 Participants
Region of Enrollment United States	12 Participants
Screen for Anxiety and Related Disorders - child report on self (SCARED-C)	38.25 units on a scale STANDARD_DEVIATION 13.24
Screen for Anxiety and Related Disorders - Parent report on child (SCARED-P)	37.17 units on a scale STANDARD_DEVIATION 13.43
Sex: Female, Male Female	9 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 12
other Total, other adverse events	0 / 12
serious Total, serious adverse events	0 / 12

Outcome results

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.