- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01732601
Intensive Outpatient Services for Teens (INVEST)
21. januar 2018 opdateret af: Anthony Spirito, Brown University
Intensive Outpatient Protocol for High Risk Suicidal Teens
This study will identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Suicidal ideation and behavior are the primary reasons for emergency psychiatric care and inpatient psychiatric hospitalization in this country.
These expensive contacts with the health care system effectively address acute suicidality for many adolescents but there is a significant subset of suicidal patients that have continued suicidality.
This study will target teens that are at risk for re-hospitalization based on continued suicidal ideation, their mood and another risk factor such as self-harm or substance use.
These risk factors have been shown to increase risk for continued suicidal behavior and expensive contacts with the health care system.
This protocol has been designed to determine whether Intensive Cognitive Behavioral Therapy (CBT), which was designed to treat adolescents with a mood disorder, suicidal ideation, and substance use, will result in better treatment outcomes compared to standard care in the community.
The Intensive CBT condition will be delivered by a team of two licensed mental health therapists over the course of one year and will work with both the teen and parent.
The standard care condition will receive treatment in the community.
One hundred-and fifty adolescents (38 a year) will be recruited from several inpatient and partial hospital locations.
Each adolescent will receive a thorough baseline assessment to determine whether they are appropriate for the study and will be assigned to either the Intensive CBT condition or treatment within the community.
Both groups of teens will receive follow-up assessments at 6, 12, and 18 months to identify how they are doing over time.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
140
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02912
- Brown University
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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
12 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Current Mood Disorder and suicidal ideation and one of the following
- NSSI
- Suicide Attempt
- Substance Use
Exclusion Criteria:
- Intelligence Quotient < 80
- Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
- Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Intensive Outpatient CBT
Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
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Sessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months.
Therapy can continue up until one year.
Andre navne:
|
Aktiv komparator: Standard Care
Standard Treatment in the Community
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Treatment at step-down facilities
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Suicide attempts
Tidsramme: Measured at 18 months from Baseline
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Self-report by parents or teens of a suicide attempt occurring in the follow-up period
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Measured at 18 months from Baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Depressed mood as assessed by the Children's Depression Rating Scale - Revised
Tidsramme: Measured at 18 months from Baseline
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Depressed mood as determined by clinical interview
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Measured at 18 months from Baseline
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse
Tidsramme: Measures 18 months from Baseline
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Self report of behaviors considered self-harming including self-inflicted behaviors such as cutting with no suicidal intent or excessive substance use with negative consequences to the individual
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Measures 18 months from Baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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.
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)
1. september 2012
Primær færdiggørelse (Faktiske)
1. oktober 2017
Studieafslutning (Faktiske)
1. januar 2018
Datoer for studieregistrering
Først indsendt
13. november 2012
Først indsendt, der opfyldte QC-kriterier
19. november 2012
Først opslået (Skøn)
26. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R01MH097703-01 (U.S. NIH-bevilling/kontrakt)
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 .
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