Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03984487|
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|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 id masked from knowing which group each participant was randomized to.|
|Official Title:||Pilot RCT of a Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder in the Last 2 Years of High School|
|Actual Study Start Date :||May 17, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2022|
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 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).
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
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.
- Vineland Adaptive Behavior Scales, 3rd Edition [ Time Frame: Though Study Completion, about 2 years ]
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.
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): NCT03984487
|Contact: Carrie T Fasslerfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Carrie T Fassler 513-803-3580 email@example.com|
|Principal Investigator: Amie M Duncan, Ph.D.|
|Principal Investigator:||Amie M Duncan, Ph.D.||Children's Hospital Medical Center, Cincinnati|