Pilot RCT of a Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder in the Last 2 Years of High School
Surviving and Thriving in the Real World
+ Program for the Education and Enrichment of Relational Skills
Trastorno del Espectro Autista
+ Trastornos Generalizados del Desarrollo Infantil
+ Trastornos Mentales
Estudio de Tratamiento
Resumen
Fecha de inicio: 17 de mayo de 2018
Fecha en la que se inscribió al primer participante.Individuals with high functioning autism spectrum disorder (ASD) are not developing the skills necessary to successfully transition from adolescence to college, employment, and independent living. Daily living skills have been linked to positive adult outcome in individuals with ASD. Despite the importance of daily living skills to adult outcome, adolescents with high functioning ASD have impaired daily living skills. A complex set of environmental, individual, and family factors likely affect the ability of adolescents with high functioning ASD to acquire critical daily living skills. There are currently no evidence-based daily living skills intervention packages for adolescents with high functioning ASD that would prepare them for independence in adulthood. The pilot RCT will consist of running 4 cohorts of 16-20 high functioning adolescents with ASD (IQ>70) and their parents in a STRW treatment group or social skills control group. Once an eligible cohort of 16-20 adolescents with ASD has been recruited, adolescents will be randomly assigned to either the STRW group or control group using a stratified randomized block design with IQ as a strata variable (IQ<85 and IQ>85) to ensure balanced group assignment for each cohort. Approximately 8-10 adolescents with ASD and their parents will participate in each STRW group. Thus, across 4 cohorts, the goal will be to enroll at least a total of 72 adolescents in the study, 36 in the STRW group and 36 in the control group across Years 1-3. To test Aim 1: Initially a two-sample t-test will be used to test the difference on the change scores in the Vineland-3 DLS domain and GAS (post-treatment and baseline) between the STRW and control groups. Although this is a randomized study it is possible that some of the demographic variables might be differentially distributed between the groups. In this case, the initial analysis will be followed by a general linear regression analysis where cohort will be treated as the main effect and other differentially distributed variables will be added to the model as possible confounders in order to investigate the independent effect of the intervention group on outcome. To test Aim 2: The within-subject change between post-treatment and 6-month follow-up for each individual receiving the intervention will be calculated and a paired t-test will be conducted to evaluate this change (post-treatment and 6-month follow-up). To test Aim 3: Exploratory analyses will be conducted to examine the relationship between progress in DLS and executive functioning, social skills, and parenting and family factors. A regression analysis will be used to estimate and examine this potential relationship. In this model the change score (post-treatment and baseline) will be modeled as a function of each of the measures of executive function, social skills and parenting and family factors. This will allow us to characterize the response profile.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 73 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.De 15 a 22 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
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
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
Cincinnati Children's Hospital Medical Center
Cincinnati, United StatesAbrir Cincinnati Children's Hospital Medical Center en Google Maps