Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD (RRFT)
2 augusti 2018 uppdaterad av: Medical University of South Carolina
Adolescents receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU).
Adolescents receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk and protective factors for substance use and abuse at the individual level (e.g., coping) and at each level of an adolescent's ecology (e.g., increased number of positive family activities, reduced family conflict, reduced number of peers who use drugs, improved school attendance, increased involvement in pro-social community activities) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will experience less PTSD symptoms (per youth and caregiver reports) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during treatment and follow-up than control adolescents who receive TAU. Changes during treatment in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth relationship) and parenting practices (monitoring) will mediate changes in substance use.
Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
See above.
Studietyp
Interventionell
Inskrivning (Faktisk)
135
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
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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
13 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 1) 13-18 years old;
- 2) Presenting to LCC/HH for evaluation or treatment;
- 3) Report having experienced IPV in their lifetime, including: CSA, defined as forced or unwanted: (a) vaginal or anal penetration by an object, finger, or penis; (b) oral sex; (c) touching of the respondent's breasts or genitalia; or (d) respondents' touching of another person's genitalia; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence.
- 4) Have a memory of the incident(s);
- 5) Five or more DSM-IV PTSD symptoms;
- 6) Substance use, defined as alcohol or illicit drug use in the past 90 days per self-report and/or urine drug screen or breathalyzer.
Exclusion Criteria:
- 1) Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;
- 2) Actively suicidal or homicidal;
- 3) Reports active psychotic disorder
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: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Treatment as Usual (TAU)
Treatment as Usual (TAU) will be defined as it already exists within the community child advocacy centers.
This could include individual and/or group therapy using a variety of treatment models.
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Participants assigned to the TAU condition will receive the standard treatment that a CSA victim would typically receive at community advocacy centers.
In addition to treatment that is typically offered at the CACs, this will include a referral for substance abuse evaluation and may include referrals to other agencies in the community.
TAU has been utilized as a comparison condition for several behavioral treatment evaluations involving adolescent substance abuse.
Andra namn:
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Experimentell: RRFT
RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy.
Please see intervention description for more detail about the model.
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RRFT is an integrative, ecologically-based approach to risk reduction and treatment.
A Stage 1a feasibility trial and a Stage 1b pilot randomized controlled trial (RCT) evaluating RRFT have been completed.
This Stage 1 work has resulted in a treatment manual, a clinician training protocol, and a quality assurance system.
Preliminary findings from these studies are promising, indicating that RRFT can be readily learned and implemented with fidelity, and that it can lead to improvements in drug use and drug use-related risk and protective factors, PTSD symptoms, and risky sexual behaviors.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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change in substance use problems (initiation/continuation, quantity, and abuse symptoms)
Tidsram: 18 months
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18 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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change in PTSD severity and symptoms
Tidsram: 18 months
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18 months
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change in risky sexual behaviors
Tidsram: 18 months
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18 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Carla K Danielson, PhD, Medical University of South Carolina
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.
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)
1 november 2012
Primärt slutförande (Faktisk)
12 juli 2018
Avslutad studie (Faktisk)
12 juli 2018
Studieregistreringsdatum
Först inskickad
15 november 2012
Först inskickad som uppfyllde QC-kriterierna
13 december 2012
Första postat (Uppskatta)
17 december 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 augusti 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 augusti 2018
Senast verifierad
1 augusti 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00009042
- R01DA031285-01 (U.S.S. NIH-anslag/kontrakt)
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 .