Homeless Youth Study - Stepping Stone 2.0
26. september 2019 opdateret af: Alyson Zalta, Rush University Medical Center
Housing instability is both a cause and consequence of mental health problems.
As such youth experiencing housing instability (e.g., homeless or marginally housed) have higher rates of mental health problems.Because of their circumstances, these youth also face significant barriers to mental health care and are therefore less likely to receive the treatment that they need.
Mobile technology may offer a novel platform for increasing access to mental health care in this population.
The primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering automated mental health interventions via smartphone technology, (2) examine the extent to which automated mental health interventions delivered via mobile technology improve mental health in homeless, marginally-housed, and exiting foster youth.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 25 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 16-25 years
- English-speaking
Youth must meet one of the following risk criteria
Experiencing housing instability as defined by:
- lacking a fixed, regular, and adequate nighttime residence OR whose primary nighttime residence is a shelter, institution, or a "public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings"
- sharing the housing of other persons due to loss of housing [or] economic hardship.
- frequent moves, poor housing quality (e.g., living in severely overcrowded housing).
- Imminently leaving the foster care system
- Willingness and ability to comply with requirements of the study protocol
Exclusion Criteria:
* Inability to understand study procedures and participate in the informed consent process.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Mobile self-help intervention
This study uses automated self-help interventions designed as a kit of smartphone tools.
|
Participants receive several apps on their phone including IntelliCare apps, which are based on principles of cognitive-behavioral therapy.
Participants also receive the Pocket Helper app, which has been designed for this study.
The tools within the Pocket Helper app include a crisis text line that is available 24/7, the Illinois Warm Line which is available Monday through Friday from 8am to 5pm, directions to call 911 in the case of an emergency, the Koko web app that provides crowdsourced emotional support, brief cognitive-behavioral interventions, daily tips, and daily surveys.
Phones will also include the StreetLight Chicago app, which provides homeless individuals with up-to-date information on shelters, health clinics, emergency contacts, mental health services, and more.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Program adherence
Tidsramme: Baseline to Endpoint (6 months)
|
Program adherence will be assessed based on usage data determining how often participants utilized the study applications, and how often they completed daily surveys and rated daily tips.
|
Baseline to Endpoint (6 months)
|
|
Program satisfaction
Tidsramme: Midpoint (3 months) and Endpoint (6 months)
|
Program satisfaction will be assessed using a self-report questionnaire that participants will be asked to complete at the midpoint and endpoint of the study.
Participants will be asked to report the extent to which they benefited from the study, how helpful the mobile applications were, and if they would recommend the study to others.
These responses are recorded on 5-point likert type scales with higher ratings indicating higher satisfaction.
|
Midpoint (3 months) and Endpoint (6 months)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety symptoms
Tidsramme: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Anxiety symptoms will be assessed using the adaptive PROMIS Bank v1.0 for anxiety.
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Depression symptoms
Tidsramme: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Depression symptoms will be assessed using the adaptive PROMIS Bank v1.0 for depression.
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Alcohol use
Tidsramme: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT-C).
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Cannabis use
Tidsramme: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Cannabis use will be assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R).
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Risky sexual behavior
Tidsramme: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Risky sexual behaviors will be assessed using the sexual behavior items from the Centers for Disease Control and Prevention's Youth Risk Behavior Survey (2011).
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
PTSD symptoms
Tidsramme: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
PTSD symptoms will be assessed using the The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Satisfaction with life: Satisfaction with Life Scale (SWLS)
Tidsramme: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
General satisfaction with life will be assessed using the Satisfaction with Life Scale (SWLS).
This measure is 5 items, with each item rated on a scale from 1-7.
All 5 items are summed to achieve a total score of 5-35.
Higher scores indicate higher satisfaction with one's life circumstances.
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Psychosocial flourishing
Tidsramme: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Psychological resources and strengths will be assessed using the Flourishing Scale (FS).
This measure is 8 items, with each item rated on a scale from 1-7.
All 8 items are summed to achieve a total score of 8-56.
Higher scores indicate that an individual has more psychological resources and strengths.
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Alyson K Zalta, PhD, University of California, Irvine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Straka K, Blacketer AR, Martinez RL, Glover A, Winiarski DA, Karnik NS, Schueller SM, Zalta AK. Rates and correlates of well-being among youth experiencing homelessness. J Community Psychol. 2022 Sep;50(8):3746-3759. doi: 10.1002/jcop.22869. Epub 2022 Apr 23.
- Glover AC, Schueller SM, Winiarski DA, Smith DL, Karnik NS, Zalta AK. Automated Mobile Phone-Based Mental Health Resource for Homeless Youth: Pilot Study Assessing Feasibility and Acceptability. JMIR Ment Health. 2019 Oct 11;6(10):e15144. doi: 10.2196/15144.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. december 2017
Primær færdiggørelse (Faktiske)
8. juli 2019
Studieafslutning (Faktiske)
8. juli 2019
Datoer for studieregistrering
Først indsendt
12. december 2018
Først indsendt, der opfyldte QC-kriterier
12. december 2018
Først opslået (Faktiske)
14. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17072403
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .