Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
Polysubstance Abuse · Posttraumatic Stress Disorder
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 76 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- must be 18 years or older,
- be a patient at the START clinic receiving methadone for treatment of opioid use disorder,
- self-report 10+ days of co-use of cocaine and illicit opioids in the past 30-days,
- meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the PC-PTSD-5.
Exclusion Criteria:
- cognitive impairment that would interfere with their ability to understand study participation as assessed by the researcher,
- does not speak/understand English at a conversational level,
- plans to leave the START clinic in the next 60 days,
- patients who missed methadone doses (inactive) for 30 days or more, or
- having received clinical care from the interventionist(s) in the past 30 days
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
Adapted STAIR-NT Intervention
No informado en este registro.
Behavioral: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)
Treatment as Usual (TAU)
No informado en este registro.
Behavioral: Treatment as Usual
Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) BEHAVIORAL
Adapted version of evidence-based behavioral PTSD intervention.
Treatment as Usual BEHAVIORAL
Treatment as usual.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Proportion of Eligible Participants
Plazo: Baseline
Proportion of persons eligible to enroll in the study of all possible MMT patients approached. Assessed using count data of individuals failing screen.
Proportion of Eligible Participants who Enroll
Plazo: Baseline
.Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.
Number of Intervention Sessions Completed
Plazo: Up to Month 3
No informado en este registro.
Clinician-Rated Feasibility of Intervention Measure (FIM) Score
Plazo: Month 3
4-item, clinician-rated assessment of the feasibility of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated feasibility.
Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score
Plazo: Month 3
4-item, clinician-rated assessment of the acceptability of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated acceptability.
Number of Days of Co-Use of Cocaine and Illicit Opioids
Plazo: Month 3
Measured using the Addiction Severity Index (ASI) questionnaire.
Number of Substances Used based on ASI Self-Report
Plazo: Month 3
Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse.
Number of Substances Used based on Urine Drug Screen
Plazo: Month 3
No informado en este registro.
Number of Substances Used based on Chart Abstraction of Toxicology Results
Plazo: Month 3
No informado en este registro.
PTSD Checklist for DSM-5 (PCL-5) Score
Plazo: Month 3
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is rated on a scale from 0-4. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; higher scores indicate greater severity of PTSD.
Negative Mood Regulation Scale Score
Plazo: Month 3
30-item assessment of individuals' beliefs and expectations regarding their ability to regulate their negative mood and emotions. Each item is rated on a 5-point Likert scale ranging from 1 (not at all effective) to 5 (extremely effective). The total score ranges from 30-150; higher scores indicate more effective negative mood regulation.
Inventory of Interpersonal Problems Score
Plazo: Month 3
A 127-item, self-report inventory that asks participants to rate a variety of interpersonal problems that may cause distress. The items are divided into two groups: (1) interpersonal inadequacies or inhibitions (78 items), (2) excesses or compulsions (49 items). Participants rate each item on a scale from 0 to 4 on how much difficulty/distress they feel regarding the item. The total score is calculated by adding the item responses; lower scores indicate less difficulty/distress.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (3)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
3 centros
Florida State UniversityTallahassee, Florida, United StatesEstado desconocido
START Treatment and Recovery CentersBrooklyn, New York, United StatesEstado desconocido
NYU Langone HealthNew York, New York, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- NYU Langone Health
- Inicio del estudio
- 14 oct 2024 Real
- Finalización primaria
- 16 sept 2026 Real
- Finalización del estudio
- 16 sept 2026 Real
- Primera publicación
- 12 mar 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026