- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01383837
HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment (STYLEnS)
27 agosto 2015 aggiornato da: New York State Psychiatric Institute
Adolescents with substance use disorders (SUD) are at substantial risk for contracting HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction interventions have been developed to meet their unique needs, and none use a family-based intervention approach, which the literature recommends as the focus for intervention for youth.
Current state policies neither require providers in clinics delivering substance use treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for HIV/STI prevention.
There is clear public health need to develop innovative methods of service delivery and effective strategies of HIV/STI sexual risk reduction that address multiple contexts of risk (i.e.
family) for this high risk population.
The current proposal addresses this need by developing a provider-delivered HIV sexual risk reduction intervention to be implemented in outpatient SUD treatment that: 1) builds the clinics' capacity to help families under their care to more comfortably address the adolescent's sexuality; 2) promotes youth's safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in care.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The incidence of HIV and (sexually transmitted infections) STI continues to rise in the US among youth, and rates of HIV/STI sexual risk behaviors among adolescents with substance use disorders (SUD) are significantly higher compared with their counterparts without SUD.
Yet HIV/STI sexual risk reduction is not regularly implemented within adolescent SUD treatment programs.
To address this urgent public health priority, the investigators propose first to develop a manualized sexual risk reduction intervention that 1) builds community clinics' capacity to help families in their care to address systematically adolescents' sexuality; 2) promotes the youths' safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in treatment.
Second, the investigators propose to pilot test the manualized intervention to examine feasibility and acceptability of implementation in real-world settings and determine optimal research parameters for such settings in preparation for a randomized clinical trial (RCT).
The intervention development process will use a Community Based Participatory Research model of adaptation and development that has been successfully implemented by the PI in other settings.
The investigators will conduct formative work to guide adaptation of a multi-family group HIV/STI sexual risk reduction intervention that has demonstrated efficacy with youth, ages 13-18, who have non-SUD psychiatric disorders (Project STYLE: Strengthening Today's Youth Life Experience; R01 MH63008; PI: Brown).
This formative work (Phase 1 - protocol 6183) will leverage the research sample of CASALEAP, an ongoing NIDA-funded, large-scale naturalistic study of the effectiveness of outpatient SUD treatment for adolescent (R01 DA019607; PI: Hogue).
The resulting new manualized intervention (STYLEnS: STYLE and Substance) then will be pilot-tested (Phase 2 - protocol 6622) with a sample of male and female adolescents with SUD (n=60) in treatment in three well-established New York City mental health outpatient treatment programs which are typical of those for adolescents with SUD and in which the investigators have active partnerships.
Pilot participants will be randomly assigned to either STYLEnS or an attention control intervention (Health Promotion).
Participants will receive a full-day group intervention on the day of randomization (multi-family, caregivers alone and adolescents alone), return in two weeks for an individual adolescent/caregiver dyad session, and participate in a half-day booster group session three months later.
The pilot test will evaluate the feasibility and acceptability of conducting an intervention in outpatient clinics treating adolescents with SUD, examine optimal factors influencing research methods, and estimate intervention parameters for a RCT.
Acceptability and feasibility will be assessed using process measures following each session as well as after the intervention is completed.
The investigators will assess change in sexual risk behavior outcomes from baseline to 3 months post-intervention.
This study will lay the groundwork for refining the design of a RCT of the new intervention.
Implementing a HIV/STI sexual risk reduction intervention in clinics providing SUD treatment represents an innovative and potentially cost-effective approach to enable typically overburdened SUD treatment providers to address the heightened HIV/STI risk in SUD youth.
This proposal responds to the need to develop HIV/STI sexual risk reduction intervention services for adolescents with SUD that can be applied in and easily disseminated to clinical settings.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
86
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
New York
-
New York, New York, Stati Uniti, 10025
- St. Lukes-Roosevelt Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 13 anni a 24 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- are in care at the pilot sites;
- are ages 13-24 years;
- meet criteria for (Diagnostic Statistical Manual) DSM-IV substance abuse diagnosis (patient record);
- have a caregiver who will consent to their study participation,
- have a parent/family member willing to enter treatment and participate in study
Exclusion Criteria:
- have mental retardation or pervasive developmental disorder as primary diagnosis;
- have a medical or psychiatric illness requiring hospitalization;
- have current psychotic features, or current suicidality;
- are not English- or Spanish-speaking
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: STYLEnS
Multifamily Group HIV/STI Prevention intervention or Single Family Dyad (youth and a parent)
|
Multifamily group HIV/STI Prevention Intervention or Single Family Dyad (youth and a parent)
|
|
Comparatore attivo: Health Promotion
Health Promotion Intervention - Adolescents only
|
Health Promotion Intervention
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Unprotected vaginal or anal sex occasions
Lasso di tempo: 3-months look back
|
3-months look back
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Caregiver-youth communication about sex
Lasso di tempo: 3-months look back
|
The Parent-Adolescent Sexual Communication Scale assesses the process and content of sexual communication between parents and adolescents.
Youth and parents complete separate versions.
|
3-months look back
|
|
Caregiver-youth communication about sexual risk behaviors
Lasso di tempo: 5-minutes
|
The Parent-Adolescent HIV Preventive Communication Skills Scale assesses the quality and process of parent-child communication; parents and adolescents are videotaped discussing a difficult topic for 5 minutes.
An observational coding system is used to match the behavior and interactive changes targeted by the Family-Based component of our intervention (e.g.
I-Statements, Negative Vocalizations, and Relationship Quality).
Coders will be trained and inter-rater reliability will be assessed.
|
5-minutes
|
|
Feasibility of conducting the intervention
Lasso di tempo: 3-months
|
Determined (yes/no) if the parent and youth attended the intervention sessions
|
3-months
|
|
Acceptability of the intervention
Lasso di tempo: 3 months
|
Adolescent and caregiver will fill out a structured post-session process measure that assesses adolescent and caregiver feedback specifically regarding intervention content, materials, format, exercises, treatment motivation, personal reactions (strengths and weaknesses, relevance, interest, satisfaction, and comfort) to receiving the interventions.
|
3 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Milton L Wainberg, MD, New York State Psychiatric Institute, Columbia University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2010
Completamento primario (Effettivo)
1 maggio 2015
Completamento dello studio (Effettivo)
1 agosto 2015
Date di iscrizione allo studio
Primo inviato
18 agosto 2010
Primo inviato che soddisfa i criteri di controllo qualità
27 giugno 2011
Primo Inserito (Stima)
28 giugno 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
28 agosto 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 agosto 2015
Ultimo verificato
1 agosto 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 6183/6622
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .