MILO-PilotPilot Study of Motivational Interviewing for Loved Ones
Motivational Interviewing for Loved Ones (MILO)
+ Mental Health Services Consultation and Waitlist
Trastornos Mentales
+ Trastornos Psicóticos
Estudio de Tratamiento
Resumen
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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 71 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.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
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos 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