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

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ClinicalTrials.gov Identifier: NCT03984513
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Surviving and Thriving in the Real World Behavioral: Program for the Education and Enrichment of Relational Skills Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
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)
Masking Description: Coordinator who is assessing goals of participants is masked from knowing which group each participant was randomized to.
Primary Purpose: Treatment
Official Title: Surviving And Thriving In The Real World: A Daily Living Skills Intervention For Adolescents With ASD
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STRW
Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW).
Behavioral: 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).

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




Primary Outcome Measures :
  1. Vineland Adaptive Behavior Scales, 3rd Edition [ Time Frame: Through Study Completion, about 2 years ]

    The Vineland Adaptive Behavior Scales, 3rd Edition (VABS-3) is a well-established standardized measure of adaptive behavior that assesses skills in the Communication, Daily Living Skills, and Socialization domains. The DLS domain is comprised of the Personal, Domestic, and Community subdomains and has items that directly correspond to goals being targeted in the STRW intervention.

    Subdomain v-scale scores: 1 to 24. Domain and Adaptive Behavior Composite Standard Scores: 20 to 140. The higher the score, the better the adaptive level. V-scale scores have a mean of 15 and standard deviation (SD) of 3. Standard scores have a mean of 100 and SD of 15.




Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984513


Contacts
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Contact: Carrie T Fassler 513-803-3580 carrie.fassler@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Carrie Fassler    513-803-3580    carrie.fassler@cchmc.org   
Principal Investigator: Amie M Duncan, Ph.D.         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Amie M Duncan, Ph.D. Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03984513     History of Changes
Other Study ID Numbers: CIN-DUNCAN-2018-5606
1K23HD094855-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders