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Homeless Youth Study - Stepping Stone 2.0

26 september 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60612
        • Rush University Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

16 år till 25 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Mobile self-help intervention
This study uses automated self-help interventions designed as a kit of smartphone tools.
Beteende: Mobile self-help intervention
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Program adherence
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Anxiety symptoms
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Rush University Medical Center

Samarbetspartners

Illinois Department of Human Services
Sparrow Mobile

Utredare

  • Studierektor: Alyson K Zalta, PhD, University of California, Irvine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 december 2017

Primärt slutförande (Faktisk)

8 juli 2019

Avslutad studie (Faktisk)

8 juli 2019

Studieregistreringsdatum

Först inskickad

12 december 2018

Först inskickad som uppfyllde QC-kriterierna

12 december 2018

Första postat (Faktisk)

14 december 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 september 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 september 2019

Senast verifierad

1 september 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 17072403

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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