- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06875323
FostrSpace-CASA R61/R33
CASA and FostrSpace: Systems Delivery of Digital Substance Use Prevention Tools to Foster Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94131
- UCSF Zuckerberg San Francisco General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents and young adults will be eligible if they are age 13-20, are proficient in English, have an assigned CASA worker, and have a device with web access.
- CASAs (ages 18 and over) will be eligible if they are assigned to a youth between the ages of 13- 20.
Exclusion Criteria:
- Youth: Exclusion criteria include being non-English speaking, being within 3 months of ending with CASA services, cognitive impairment that precludes ability to provide informed consent.
- CASA: Exclusion criteria include being non-English speaking and working with a youth who is within 3 months of ending with CASA services.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: InfoECHO
CASA volunteers will attend a six 90-minute/biweekly co-occurring SU and trauma ECHO trainings.
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Six ECHO-FostrSpace session training for CASA volunteers.
|
|
Other: InfoOnly
CASA volunteers will attend a one-time 30-60 minute co-occurring SU and trauma ECHO training.
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One ECHO-FostrSpace session training for CASA volunteers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Drug Use
Time Frame: baseline
|
The Texas Christian University (TCU) drug screen with opioid supplement is used to gather detailed information about drug and opioid use.
|
baseline
|
|
Rate of Cigarette Use
Time Frame: baseline
|
The Cigarette smoking and vaping/e-cigarette use is used to gather detailed information about nicotine and/or cannabis use.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Alcohol and Marijuana Expectancy Questionnaire
Time Frame: baseline
|
The Alcohol and Marijuana Expectancy questionnaire is used to measure positive and negative expectancies about affective, cognitive and behavioral effects of alcohol and cannabis use.
Items are rated from 1-5 scale and higher scores indicate negative alcohol and marijuana expectancies.
|
baseline
|
|
The Brief Young Adult Alcohol Consequences Questionnaire
Time Frame: baseline
|
The Brief Young Adult Alcohol Consequences Questionnaire is used to assess the severity of alcohol consumption.
Higher scores indicate greater severity of consequences associated with alcohol consumption.
|
baseline
|
|
The Brief Marijuana Consequences Questionnaire
Time Frame: baseline
|
The Brief Marijuana Consequences Questionnaire is used to assess the severity of marijuana consumption.
Higher scores indicate greater severity of consequences associated with marijuana consumption.
|
baseline
|
|
The Brief Symptom Inventory
Time Frame: baseline
|
Brief Symptom Inventory is used to measure depression, anxiety and somatization symptoms to assess for psychiatry distress.
Index ranging from 0 to 72 with cut-score of 11 as indication of psychiatric distress.
|
baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CASA Background Characteristics
Time Frame: baseline
|
Demographics questionnaire used to gather standard demographics (e.g., age, gender, race) and information such as state agency involvement (e.g., age at first contact with child welfare, number of out-of-home placements, length of time worked with a CASA), immigration status.
|
baseline
|
|
Arrest and Treatment
Time Frame: baseline
|
The Arrest and treatment history (ATH) questionnaire is used to gather information about past juvenile legal system contact (arrest, probation, detention), mental health (MH) and substance use (SU) diagnoses, and past services utilization for SU and/or MH (inpatient, residential, outpatient).
|
baseline
|
|
Youth Background Characteristics
Time Frame: baseline
|
Youth's living situation questionnaire will be used to gather information related to the youth's living situation over the past 4 months (e.g., in the community, residential treatment, or other living situation).
|
baseline
|
|
Social Determinants of Health
Time Frame: baseline
|
We will administer an 18-item yes/no questionnaire to gather information on what youth perceive as most relevant and important social determinants of health items for foster youth (i.e., employment, food, family, healthcare, housing, legal, education, safety at school/work, transportation, "other" needs).
|
baseline
|
|
Therapeutic Alliance
Time Frame: baseline
|
The Working Alliance Inventory (WAI) is used to assess youth's perception of therapeutic alliance (with provider) over time.
Scores range from 12-84 with higher scores indicating greater perceived therapeutic alliance.
|
baseline
|
|
Youth/CASA Relationship
Time Frame: baseline
|
Frequency and quality of CASA-youth conversations about substance use: For frequency, we will adapt an item from a validated measure of parent-child communication about sex used in previous studies45 "How many times have you and your CASA talked about [alcohol, marijuana, cocaine]" (each drug asked separately).
For quality, we will use one-item from the scale that assesses perceived helpfulness 'How helpful do you think your discussions about alcohol and/or drugs were?' and one-item that assesses perceived comfort 'How comfortable are you with these discussions about alcohol and/or drugs with your [CASA youth] or [CASA].
|
baseline
|
|
Trauma
Time Frame: baseline
|
6: deidentified assessment of Adverse Childhood Experiences (10 items) and Related Life Events (7 items).
|
baseline
|
|
Ethnic Identity
Time Frame: baseline
|
The Scale of Ethnic Experience is used to measures youth ethnicity-related cognitive constructs (e.g., perceptions of their own ethnic group, ethnic group belonging) in four domains: Ethnic Identity(12-items; α =.87); Perceived Discrimination (9-items; α = .91);
Mainstream Comfort (6-items; α=.87); and Social Affiliation (5-items; α =.83).
Items rated on a scale from 1 (strongly disagree) to 5(strongly agree).
|
baseline
|
|
Stigma
Time Frame: baseline
|
The Social Distance Scale (SDS) is used to assess a person's willingness to interact with others with mental illness (SDS) or substance users (SDS-SU).
|
baseline
|
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Peer Substance Use
Time Frame: baseline
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The Monitoring the Future is used to assess how many close friends are using alcohol, cannabis and other drugs occasionally and regularly.
|
baseline
|
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Background Characteristics
Time Frame: baseline
|
A Demographics Questionnaire is used to gather standard demographics (e.g., age, gender, race) and information about employment, number of years as CASA volunteer, length of time known current foster youth, immigration status, country of origin.
|
baseline
|
|
Substance use prevention related knowledge, beliefs, attitudes and self efficacy
Time Frame: baseline
|
Beliefs about youth SU will be measured using an adapted 9 item perceived risk of SU measure used in studies of similar risk perceptions (among parents) associated with youth substance use.
Items such as "If your youth were to use alcohol more than once a week, what do you think are the chances of them becoming (for example) addicted to alcohol, developing cancer (or lung cancer for drugs that can be smoked), experiencing brain injury etc.
|
baseline
|
|
Compassion Satisfaction and Fatigue
Time Frame: 30 days post baseline, 60 days post baseline
|
The Professional Quality of Life will be used to gather information about compassion satisfaction and compassion fatigue.
|
30 days post baseline, 60 days post baseline
|
|
FostrSpace App Utilization
Time Frame: baseline, 30 days post baseline, 60 days post baseline
|
Number of app log-in's, days of use, time spent using app, number and type of features used e.g.,chat use (peer/FAB), chat use (navigator), number of clicks on SU prevention content (e.g., SU resources requested, peer "adulting 101" SU prevention video watched), requested navigator support (yes/no), requested navigator support about SU (yes/no), requested teletherapy [primary presenting need, type of intervention, e.g., primary SU or MH or co-occurring, modality of intervention (individual, group, family), number and frequency of sessions received].
|
baseline, 30 days post baseline, 60 days post baseline
|
|
Psychiatric Symptoms
Time Frame: baseline
|
The Emotional Wellness Questionnaire is used to assess psychiatric symptoms (e.g., depression, anxiety, mania) and substance use.
|
baseline
|
|
FostrSpace Usability
Time Frame: 30 days post baseline, 60 days post baseline
|
The System Usability Scale (SUS) is used to gather information about the overall usability of web applications. 10- item measure widely used for web applications and proven superior to other measures. SUS yields a single number representing a composite measures of the overall usability of the system being studied60,61. Scores will be compared to established norms for levels of usability. Our goal is a score of 80 (top 10% of scores), which reflects excellent usability, and is associated with recommending the product to a friend. |
30 days post baseline, 60 days post baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marina Tolou-Shams, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R61DA059860-01 (U.S. NIH Grant/Contract)
- R61DA059860 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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