Trial Outcomes & Findings for Video-visit Behavior Therapy for Anxiety and Depression in Youth (NCT NCT05417412)
NCT ID: NCT05417412
Last Updated: 2024-05-16
Results Overview
Receipt of a minimum dose of intervention. A minimum dose was defined as 8 or more sessions of the intervention.
COMPLETED
NA
12 participants
Week 16 (post-intervention)
2024-05-16
Participant Flow
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.
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Video-visit Behavior Therapy for Anxiety and Depression in Youth
Baseline characteristics by cohort
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=12 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
|
Screen for Anxiety and Related Disorders - Parent report on child (SCARED-P)
|
37.17 units on a scale
STANDARD_DEVIATION 13.43 • n=5 Participants
|
|
Screen for Anxiety and Related Disorders - child report on self (SCARED-C)
|
38.25 units on a scale
STANDARD_DEVIATION 13.24 • n=5 Participants
|
|
Mood and Feelings Questionnaire - parent report on child (MFQ-P)
|
13.25 units on a scale
STANDARD_DEVIATION 6.48 • n=5 Participants
|
|
Mood and Feelings Questionnaire child report on self (MFQ-C)
|
21.83 units on a scale
STANDARD_DEVIATION 11.28 • n=5 Participants
|
|
Insurance status
Private insurance
|
3 Participants
n=5 Participants
|
|
Insurance status
Medicaid / uninsured
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16 (post-intervention)Population: 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.
Receipt of a minimum dose of intervention. A minimum dose was defined as 8 or more sessions of the intervention.
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=12 Participants
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)
|
|---|---|
|
Minimum Attendance
Attended less than 8 sessions
|
5 Participants
|
|
Minimum Attendance
Attended 8 or more sessions
|
7 Participants
|
PRIMARY outcome
Timeframe: 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."
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=12 Participants
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)
|
|---|---|
|
Client Satisfaction Scale - Parent (CSQ-8-P)
Satisfied
|
9 Participants
|
|
Client Satisfaction Scale - Parent (CSQ-8-P)
Unsatisfied
|
0 Participants
|
|
Client Satisfaction Scale - Parent (CSQ-8-P)
Unknown / lost to follow-up
|
3 Participants
|
PRIMARY outcome
Timeframe: 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."
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=12 Participants
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)
|
|---|---|
|
Client Satisfaction Scale - Child (CSQ-8-C)
Satisfied
|
10 Participants
|
|
Client Satisfaction Scale - Child (CSQ-8-C)
Unsatisfied
|
0 Participants
|
|
Client Satisfaction Scale - Child (CSQ-8-C)
Unknown / lost to follow-up
|
2 Participants
|
PRIMARY outcome
Timeframe: 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."
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=12 Participants
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)
|
|---|---|
|
Participant Acceptability Questionnaire - Parent (PAQ-P)
Little to no technical problems
|
6 Participants
|
|
Participant Acceptability Questionnaire - Parent (PAQ-P)
Technical difficulties
|
3 Participants
|
|
Participant Acceptability Questionnaire - Parent (PAQ-P)
Unknown / lost to follow up
|
3 Participants
|
PRIMARY outcome
Timeframe: 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."
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=12 Participants
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)
|
|---|---|
|
Participant Acceptability Questionnaire - Child (PAQ-C)
Unlikely to recommend program to a friend
|
1 Participants
|
|
Participant Acceptability Questionnaire - Child (PAQ-C)
Would recommend program to a friend
|
9 Participants
|
|
Participant Acceptability Questionnaire - Child (PAQ-C)
Unknown / lost to follow-up
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 16 (post-intervention)Population: Descriptive statistics at Week 16 are based on participants not lost to follow-up.
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.
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=9 Participants
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)
|
|---|---|
|
Screen for Child Anxiety and Related Disorders - Parent (SCARED-P)
|
30.00 score on a scale
Standard Deviation 17.66
|
SECONDARY outcome
Timeframe: Week 16 (post-intervention)Population: Descriptive statistics at Week 16 are based on participants not lost to follow-up.
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.
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=10 Participants
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)
|
|---|---|
|
Screen for Child Anxiety and Related Disorders - Child (SCARED-C)
|
28.80 score on a scale
Standard Deviation 13.66
|
SECONDARY outcome
Timeframe: Week 16 (post-intervention)Population: Descriptive statistics at Week 16 are based on participants not lost to follow-up.
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.
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=9 Participants
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)
|
|---|---|
|
Mood and Feelings Questionnaire - Parent (MFQ-P)
|
15.22 score on a scale
Standard Deviation 10.96
|
SECONDARY outcome
Timeframe: Week 16 (post-intervention)Population: Descriptive statistics at Week 16 are based on participants not lost to follow-up.
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.
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=10 Participants
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)
|
|---|---|
|
Mood and Feelings Questionnaire - Child (MFQ-C)
|
18.00 score on a scale
Standard Deviation 8.78
|
SECONDARY outcome
Timeframe: Week 16 (post-intervention)Population: Descriptive statistics at Week 16 are based on participants not lost to follow-up.
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.
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=9 Participants
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)
|
|---|---|
|
Symptom Impairment Scale - Parent (SIS-P)
|
6.44 score on a scale
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: Week 16 (post-intervention)Population: Descriptive statistics at Week 16 are based on participants not lost to follow-up.
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.
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=10 Participants
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)
|
|---|---|
|
Symptom Impairment Scale - Child (SIS-C)
|
7.80 score on a scale
Standard Deviation 3.77
|
SECONDARY outcome
Timeframe: Week 16 (post-intervention)Population: Descriptive statistics at Week 16 are based on participants not lost to follow-up.
Parent rating of youth avoidance behaviors due to anxiety. Scores range from 0 to 24, and higher scores indicate greater avoidance.
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=9 Participants
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)
|
|---|---|
|
Child Avoidance Measure - Parent (CAMP)
|
11.78 score on a scale
Standard Deviation 5.43
|
SECONDARY outcome
Timeframe: Week 16 (post-intervention)Population: Descriptive statistics at Week 16 are based on participants not lost to follow-up.
Youth self-report rating of avoidance behaviors due to anxiety. Scores range from 0 to 24, and higher scores indicate greater avoidance.
Outcome measures
| Measure |
STEP-UP (Brief Behavioral Therapy)
n=9 Participants
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)
|
|---|---|
|
Child Avoidance Measure - Child (CAMP)
|
11.44 score on a scale
Standard Deviation 5.70
|
Adverse Events
STEP-UP (Brief Behavioral Therapy)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place