FostrSpace-CASA R61/R33

March 7, 2025 updated by: University of California, San Francisco

CASA and FostrSpace: Systems Delivery of Digital Substance Use Prevention Tools to Foster Youth

The purpose of this study is to understand how an online digital health application (app) called FostrSpace can reduce substance use among youth (ages 13-20 years old) in foster care.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The goal of this clinical trial is to identify gaps in substance use prevention across existing CASA trainings and the FostrSpace app for foster youth and test how substance use trainings for CASA volunteers could help facilitate FostrSace app referrals to reduce and prevent substance use among CASA youth.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94131
        • UCSF Zuckerberg San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
One ECHO-FostrSpace session training for CASA volunteers.

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
Peer Substance Use
Time Frame: baseline
The Monitoring the Future is used to assess how many close friends are using alcohol, cannabis and other drugs occasionally and regularly.
baseline
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marina Tolou-Shams, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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