Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surviving and Thriving in the Real World
Program for the Education and Enrichment of Relational Skills
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- in the last 2 years of high school
- diagnosis of ASD based on clinical judgement and/or meeting the cut-off score on the Autism Diagnostic Observation Schedule, 2nd Edition
- full scale IQ of 70 or above as measured by the Stanford Binet Intelligence Scales, 5th Edition
- deficient Daily Living Skills as assessed by the Vineland Adaptive Behavior Scales, 3rd Edition - at least 1 of the 3 Daily Living Skills subdomains is at least 15 points below their full scale IQ
Exclusion Criteria:
- significant aggressive behaviors or mental health issues that require treatment out of the scope of the current intervention.
- if 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).
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STRW
PEERS
Arm Description
Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW).
Participants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS).
Outcomes
Primary Outcome Measures
Vineland Adaptive Behavior Scales, 3rd Edition
The 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03984487
First Posted
May 24, 2019
Last Updated
February 6, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT03984487
Brief Title
Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder
Official Title
Pilot RCT of a Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder in the Last 2 Years of High School
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Coordinator who is assessing goals of participants id masked from knowing which group each participant was randomized to.
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STRW
Arm Type
Experimental
Arm Description
Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW).
Arm Title
PEERS
Arm Type
Active Comparator
Arm Description
Participants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS).
Intervention Type
Behavioral
Intervention Name(s)
Surviving and Thriving in the Real World
Intervention Description
The STRW intervention consists of 14 weekly concurrent adolescent and parent group sessions. The DLS 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 DLS 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
Intervention Name(s)
Program for the Education and Enrichment of Relational Skills
Intervention Description
PEERS 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 get-togethers with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.
Primary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scales, 3rd Edition
Description
The 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.
Time Frame
Though Study Completion, about 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
in the last 2 years of high school
diagnosis of ASD based on clinical judgement and/or meeting the cut-off score on the Autism Diagnostic Observation Schedule, 2nd Edition
full scale IQ of 70 or above as measured by the Stanford Binet Intelligence Scales, 5th Edition
deficient Daily Living Skills as assessed by the Vineland Adaptive Behavior Scales, 3rd Edition - at least 1 of the 3 Daily Living Skills subdomains is at least 15 points below their full scale IQ
Exclusion Criteria:
significant aggressive behaviors or mental health issues that require treatment out of the scope of the current intervention.
if 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amie M Duncan, Ph.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder
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