Daily Living Skills Intervention for 9th and 10th Graders With Autism Spectrum Disorders

NCT ID: NCT03984513

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-25
• Study Completion Date: 2022-02-28

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

STRW

Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW).

Group Type: EXPERIMENTAL

Surviving and Thriving in the Real World

Intervention Type: BEHAVIORAL

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).

PEERS

Participants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS).

Group Type: ACTIVE_COMPARATOR

Program for the Education and Enrichment of Relational Skills

Intervention Type: BEHAVIORAL

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.

Interventions

Surviving and Thriving in the Real World

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).

Intervention Type: BEHAVIORAL

Program for the Education and Enrichment of Relational Skills

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amie M Duncan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23HD094855-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CIN-DUNCAN-2018-5606

Identifier Type: -

Identifier Source: org_study_id