Daily Living Skills Intervention for 9th and 10th Graders With Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): Surviving and Thriving in the Real World; Program for the Education and Enrichment of Relational Skills
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Surviving and Thriving in the Real World intervention consists of 14 weekly concurrent adolescent and parent group sessions. The daily living skills to be targeted in the intervention include: Morning Routine (i.e., completing a morning personal hygiene routine); Laundry (i.e., sorting clothing, using a washing machine and dryer, and folding and putting clothes away); Kitchen/Cooking (i.e., cooking items in the microwave, oven, and stove, safe kitchen practices, cleaning up the kitchen after cooking, and grocery shopping); Self-Management (i.e., managing worry and stress related to learning daily living skills and transitioning to adulthood); and Money Management (i.e., using money to purchase items, evaluating the quality and price of items, understanding and using a checking and savings account, and budgeting money to cover expenses).; Program for the Education and Enrichment of Relational Skills is an evidence-based social skills training program for youth with social challenges between the ages of 13-18.The program includes a teen group and a parent group that meet concurrently. Teens learn about conversations, electronic communication, joining groups, humor, handling teasing and disagreements, and planning a get-together with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment