Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R56MH125159 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| OCHIN, Inc. | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEP-UP (brief behavioral therapy) | Experimental | Intervention arm of open trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Therapy | Behavioral | 8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff at participating community health centers (CHCs) |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Attendance | Receipt of a minimum dose of intervention. A minimum dose was defined as 8 or more sessions of the intervention. | 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." | 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." | 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." | 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." | Week 16 (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 (post-intervention) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northwest Center for Health Research | Portland | Oregon | 97227 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Youths with significant symptoms of anxiety and depression were recruited through electronic medical record screening and clinican referral. Youths were the target of treatment and the enrolled participants. As youth are minors, consent for youth participation was sought from parents, and information on youths obatined from parents / guardians in addition to youth self-report.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Parent report of youth age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minimum Attendance | Receipt of a minimum dose of intervention. A minimum dose was defined as 8 or more sessions of the intervention. | 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. | Posted | Count of Participants | Participants | Week 16 (post-intervention) |
|
Data collected from baseline (Week 0) through follow-up (Week 16)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STEP-UP (Brief Behavioral Therapy) | Intervention arm of open trial Brief Behavioral Therapy: 8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff via telehealth at participating community health centers (CHCs) |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. V. Robin Weersing | San Diego State University | 619-594-8892 | robin.weersing@sdsu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2024 | May 7, 2024 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 16 (post-intervention) |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Parent and youth report of youth sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Parent report of youth ethnicity | Count of Participants | Participants |
|
| Race (NIH/OMB) | Parent report of youth race | Count of Participants | Participants |
|
| Region of Enrollment | Data collected from targeted clinics in known geographic regions within the United States | Count of Participants | Participants |
|
| Screen for Anxiety and Related Disorders - Parent report on child (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. | Mean | Standard Deviation | units on a scale |
|
| Screen for Anxiety and Related Disorders - child report on self (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. | Mean | Standard Deviation | units on a scale |
|
| Mood and Feelings Questionnaire - parent report on child (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. | Mean | Standard Deviation | units on a scale |
|
| Mood and Feelings Questionnaire child report on self (MFQ-C) | Total score on the Mood and Feelings Questionnaire - youth report on self (MFQ-C) a dimensional measure of depression symptoms. Scores range from 0 to 66, and higher scores indicate greater depression symptom severity. | Mean | Standard Deviation | units on a scale |
|
| Insurance status | Parent report of family health insurance coverage | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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." | Posted | Count of Participants | Participants | Week 16 (post-intervention) |
|
|
|
| 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." | Posted | Count of Participants | Participants | Week 16 (post-intervention) |
|
|
|
| Primary | 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." | Posted | Count of Participants | Participants | Week 16 (post-intervention) |
|
|
|
| Primary | 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." | Posted | Count of Participants | Participants | Week 16 (post-intervention) |
|
|
|
| Secondary | 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. | Descriptive statistics at Week 16 are based on participants not lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Week 16 (post-intervention) |
|
|
|
| Secondary | 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. | Descriptive statistics at Week 16 are based on participants not lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Week 16 (post-intervention) |
|
|
|
| Secondary | 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. | Descriptive statistics at Week 16 are based on participants not lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Week 16 (post-intervention) |
|
|
|
| Secondary | 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. | Descriptive statistics at Week 16 are based on participants not lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Week 16 (post-intervention) |
|
|
|
| Secondary | 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. | Descriptive statistics at Week 16 are based on participants not lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Week 16 (post-intervention) |
|
|
|
| Secondary | 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. | Descriptive statistics at Week 16 are based on participants not lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Week 16 (post-intervention) |
|
|
|
| Secondary | 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. | Descriptive statistics at Week 16 are based on participants not lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Week 16 (post-intervention) |
|
|
|
| Secondary | 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. | Descriptive statistics at Week 16 are based on participants not lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Week 16 (post-intervention) |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
Not provided
Not provided