Autism Spectrum DisorderNCT03984487
Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder
A study testing Surviving and Thriving in the Real World and Program for the Education and Enrichment of Relational Skills in people with Autism Spectrum Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Surviving and Thriving in the Real World and Program for the Education and Enrichment of Relational Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Pilot RCT of a Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder in the Last 2 Years of High School
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Surviving and Thriving in the Real World, Program for the Education and Enrichment of Relational Skills
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surviving and Thriving in the Real WorldBehavioural
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).
Program for the Education and Enrichment of Relational SkillsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| STRW | Experimental | Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW). Receives: Behavioral: Surviving and Thriving in the Real World |
| PEERS | Active comparator | Participants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS). Receives: Behavioral: Program for the Education and Enrichment of Relational Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 Daily Living Skills domain is comprised of the Personal, Domestic, and Community subdomains and has items that directly correspond to goals being targeted in the STRW intervention.
We are reporting the average (mean) Daily Living Skills Domain Raw Scores, both at baseline at post-treatment. The range for total raw score for the entire domain is 0 to 286.
The higher the score, the more independent they are at overall daily living skills.
Measured: 4 months (from baseline to post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start17 May 2018
- Primary completion30 Jun 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Amie M Duncan, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984487
- Sponsor's protocol ID
- CIN-DUNCAN-2018-2886
- Status last verified
- Jul 2024
- First submitted
- 24 May 2019
- Last updated
- 23 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT of a Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder in the Last 2 Years of High School
- ClinicalTrials.gov ID
- NCT03984487
- Acronym / sponsor ID
- CIN-DUNCAN-2018-2886
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 17 May 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Posted 23 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| STRW | Experimental | Behavioral: Surviving and Thriving in the Real WorldParticipants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW). |
| PEERS | Active comparator | Behavioral: Program for the Education and Enrichment of Relational SkillsParticipants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS). |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surviving and Thriving in the Real WorldThe 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). | Behavioural | STRW |
| Program for the Education and Enrichment of Relational SkillsPEERS 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. | Behavioural | PEERS |
Primary outcome
Vineland Adaptive Behavior Scales, 3rd Edition
Time frame: 4 months (from baseline to post-intervention)
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 Daily Living Skills domain is comprised of the Personal, Domestic, and Community subdomains and has items that directly correspond to goals being targeted in the STRW intervention. We are reporting the average (mean) Daily Living Skills Domain Raw Scores, both at baseline at post-treatment. The range for total raw score for the entire domain is 0 to 286. The higher the score, the more independent they are at overall daily living skills.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amie M Duncan, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surviving and Thriving in the Real World and Program for the Education and Enrichment of Relational Skills in people with Autism Spectrum Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vineland Adaptive Behavior Scales, 3rd Edition (time frame: 4 months (from baseline to post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.