Clinical trial NCT03984513: Daily Living Skills Intervention for 9th and 10th Graders With Autism Spectrum Disorders
Official title: Surviving And Thriving In The Real World: A Daily Living Skills Intervention For Adolescents With ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-06-13
Enrollment: 58
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial - A study in which the participants are divided by chance into separate groups that compare different treatments or other interventions.
Primary purpose: TREATMENT

Brief summary: The current study seeks to develop the first daily living skills (DLS) intervention package for high functioning adolescents with autism spectrum disorder (ASD) and evaluate its effectiveness. The investigators hope to further refine the Surviving and Thriving in the Real World (STRW) intervention by conducting an ORBIT (Obesity-Related Behavioral Intervention Trial) Phase 2b feasibility Randomized Clinical Trial (RCT). This randomized clinical trial will test the preliminary effectiveness of STRW in 56 adolescents (14-21 years) with high functioning ASD as compared to a robust evidence-based social skills intervention (Program for the Evaluation and Enrichment of Relational Skills - PEERS). The current proposal represents a critical step toward improving the adult outcome of individuals with autism.

Detailed description: Individuals with high functioning autism are not developing the skills necessary to successfully transition from adolescence to college, employment, and independent living. Daily living skills (DLS) have been linked to positive adult outcome in individuals with autism. Studies have consistently found that adults with high functioning autism who have better developed daily living skills were more likely to attend college, be employed, have more meaningful social relationships, and have an increased quality of life as compared to those with poor daily living skills. A complex set of environmental, individual, and family factors likely affect the ability of adolescents with high functioning autism to acquire critical daily living skills. There are currently no evidence-based daily living skills intervention packages for adolescents with high functioning autism that would prepare them for independence in adulthood.

The current study involving human subjects consists of (1) a measurement development phase to develop, adapt, and pilot objective outcome measures of daily living skills and (2) a feasibility randomized clinical trial to test the feasibility and effectiveness of the Surviving and Thriving in the Real World intervention as compared to a social skills intervention. For the measurement development phase, 2 outcome measures (i.e., Daily Phone Diaries (DPDs) and behavioral observation measures of targeted daily living skills) will be developed/adapted and piloted with approximately 10 adolescents with autism between the ages of 14-21 and their parents. For the feasibility randomized clinical trial to test the preliminary effectiveness of Surviving and Thriving in the Real World, a total of 56 adolescents with autism between the ages of 14-21 will be randomized to Surviving and Thriving in the Real World (n=28) or a social skills group (n=28). Outcome measures will be assessed at baseline, post-treatment, and 6-month follow-up.

Power Analyses: The feasibility randomized clinical trial is being conducted with the intent of examining the differences in daily living skills to be expected. Few studies have examined the trajectory of daily living skills in individuals with autism, and no studies have examined how daily living skills develop during adolescence. Power calculations focused on the anticipated increase or improvement in the age equivalence scores of each of the Vineland-3 daily living skills subdomains for the Surviving and Thriving in the Real World group and control group. The investigators used conservative estimates of change in daily living skills subdomain age equivalence scores for the investigator's sample size estimation, even though a recent pre-post trial and pilot randomized clinical trial on Surviving and Thriving in the Real World found a mean improvement of 2.3 to 2.6 years across the 3 subdomains from baseline to post-treatment.

Aim 1: For each Vineland-3 daily living skills subdomain, the investigators anticipate that adolescents in the Surviving and Thriving in the Real World group will have a mean improvement of 11 months (a mean gain in age equivalence of 11 months) at post-treatment compared to a mean improvement of 4 months in the control group. Assuming a conservative pooled standard deviation of 8.4, the investigators will have 80% power to detect the above effect size (of 0.8) with 24 participants per group. Accounting for a potential 15% drop out rate, the effective sample size is 28 per group. Based on the investigator's past studies, the investigators would expect the mean improvement in the Surviving and Thriving in the Real World group to be 16 months, but the investigators wanted to be conservative and estimate the sample size based on detecting a mean improvement as small as 11 months in the Surviving and Thriving in the Real World group.

Aim 2: For each daily living skills subdomain, the investigators anticipate that all participants who receive the Surviving and Thriving in the Real World treatment will maintain treatment gains from post-treatment to 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* attending high school
* a diagnosis of autism spectrum disorder (ASD) (based on meeting the cut-off score on the Autism Diagnostic Observation Schedule, 2nd Edition.
* a full scale Intelligence Quotient (IQ) of 70 or above as measured by the Stanford Binet Intelligence Scales, 5th Edition.
* deficient daily living skills as assessed by the Vineland-3.

Exclusion Criteria:

* psychosis or other major psychiatric disorder requiring intensive treatment
* the adolescent has already completed the social skills group (PEERS), either at Cincinnati Children's or in another setting, unless it has been a significant amount of time since they did the PEERS group (2-3 years, or up to the discretion of the PI).

Primary outcomes:
measure: Vineland Adaptive Behavior Scales, 3rd Edition
timeFrame: At Baseline, at Post-Group (approx. 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Amie M Duncan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: