Clinical Trials Logo

Clinical Trial Summary

The main objective of the current proposal is to conduct a pilot RCT (i.e., treatment group and social skills control group) to examine how participation in Surviving and Thriving in the Real World (STRW) Intervention affects proximal outcomes with a larger sample size (n = 72). As social skills, executive functioning, and parenting factors have been linked to the acquisition of Daily Living Skills (DLS), the current study will also explore how these are linked to participation in STRW. Lastly, goal attainment scaling (GAS) will be utilized, along with gold standard parent report and adolescent self-report measures, to assess DLS.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03984487
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact
Status Active, not recruiting
Phase N/A
Start date May 17, 2018
Completion date August 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT05207956 - App for Strengthening Services In Specialized Therapeutic Support N/A
Completed NCT03286621 - Development of Eye-tracking Based Markers for Autism in Young Children
Completed NCT02608333 - Efficiency of Early Intervention for Autism Spectrum Disorder N/A
Recruiting NCT05935722 - Evaluation of a Home-based Parenting Support Program: Parenting Young Children N/A
Active, not recruiting NCT06259539 - A YouTube Curriculum for Children With Autism and Obesity N/A
Active, not recruiting NCT06303791 - Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT04772898 - Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder N/A
Recruiting NCT04987541 - The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder N/A
Completed NCT04308915 - Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders N/A
Completed NCT06038435 - The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Completed NCT03693313 - The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP) N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Recruiting NCT03812068 - Parent-mediated Developmental Behavioral Intervention N/A
Completed NCT03206996 - Exposure Therapy for Auditory Sensitivity in Autism N/A
Completed NCT02299700 - Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder N/A
Completed NCT03422016 - Electroretinogram in Autistic Spectrum Disorders
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Recruiting NCT05114538 - Improving the Part C Early Intervention Service Delivery System for Children With ASD N/A