Completado

MILO-PilotPilot Study of Motivational Interviewing for Loved Ones

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Motivational Interviewing for Loved Ones (MILO)

+ Mental Health Services Consultation and Waitlist

Conductual
Quiénes están siendo reclutados

Trastornos Mentales

+ Trastornos Psicóticos

A partir de 18 años
+3 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: marzo de 2020
Ver detalles del protocolo

Resumen

Patrocinador PrincipalBoston Medical Center
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de marzo de 2020

Fecha en la que se inscribió al primer participante.

First Episode Psychosis (FEP) often represents a time of crisis for young people and their families. Since peak onset occurs during late adolescence and early adulthood, the onset of serious mental health challenges can disrupt plans for education, relationships, and other milestones of independence. Although some psychoses are brief and self-limiting, more often these symptoms portend a potentially chronic and disabling psychiatric disorder such as schizophrenia. FEP can also be acutely dangerous: youth with FEP are far more likely to die in the year following their diagnosis relative to the general population of 16-30 year old's in the United States. Approximately 100,000 youth in the United States experience FEP every year. Young people identified by providers as experiencing FEP often slip through the cracks before they reach appropriate treatment. A review of privately insured adolescents and young adults in the US showed that 62% of young people in the US with FEP filled no outpatient prescriptions, and 41% received no outpatient psychotherapy, in the year following their index diagnosis. Among those who do have an initial encounter with specialized FEP outpatient care, high attrition is a common problem, with 30% of individuals initially enrolled in first episode programs dropping out prior to completing treatment. Many individuals experiencing psychosis are reluctant to seek mental health treatment due to lack of insight and fear of psychiatric interventions. Young adults may be torn between distress and dissatisfaction relating to their symptoms and functioning, and mistrust of mental health providers and irritation with their parents' concern. Motivational Interviewing (MI) techniques are designed to elicit this ambivalence through nonjudgmental listening, so that discrepancies between current behaviors and ideal outcomes can be explored. Clinician-delivered MI has been identified as effective for enhancing adherence once individuals with psychosis are involved in care, and may also be useful for engaging those who are not yet interested in treatment. Several studies have found positive results in training and deploying non-professionals to use MI to influence others' health behaviors. MI training for parents and concerned significant others (PCSO) is a promising venue through which PCSO can specifically influence their loved one's decision to seek care and adhere to treatment plans. MILO is a structured and goal oriented intervention that seeks to accomplish two aims. The primary aim is to facilitate the engagement of IP with evidence-based treatments. The secondary aim is to reduce the distress and increase the wellbeing of PCSO. The intervention will be trialed for feasibility (phase 1, n = 30) and then tested against a small "treatment as usual" (TAU) control arm (phase 2, n = 40). During phase 2, participants will be randomly assigned to either receive MILO (50%) or TAU (50%). The trial will involve a total of 70 participants.

Título OficialPilot Study of Motivational Interviewing for Loved Ones
NCT04010747
Patrocinador PrincipalBoston Medical Center
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 71 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastornos MentalesTrastornos Psicóticos

Criterios

2 criterios de inclusión requeridos para participar
Primary caregiver or other close contact of an individual within first 5 years of onset of a psychotic disorder who is poorly engaged or unengaged in psychiatric treatment

Age 18 or older

Un criterio de exclusión impide participar
No capacitado para traducir el texto debido a mi limitado conocimiento del inglés.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Comparador Activo
This consultation will consist of a 30 minute appointment in which participants can speak with a clinician knowledgeable about psychosis treatment resources. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will then be placed on a 6-week waitlist, after which they will have the opportunity to participate in the active intervention (four sessions of MILO).

Grupo II

Experimental
MILO consists of four sessions of "coaching" in communication skills called motivational interviewing. Participants meet with a trainer/therapist for each session. At the first session, participants learn about the ideas behind motivational interviewing. In the second session, participants practice motivational interviewing skills. In the third and fourth sessions, the participant and therapist discuss the participant's efforts to communicate with their loved one using MI skills. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

Boston Medical Center

Boston, United StatesAbrir Boston Medical Center en Google Maps
Completado1 Centros de Estudio
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