Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552286
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
STRW-T Intervention for Autistic Adolescents in 11th and 12th Grade
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multisite RCT of a Daily Living Skills Intervention for Autistic Adolescents Prior to the Transition to Adulthood
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRW-T
Brief Summary:
The current study seeks to compare outcomes of a telehealth intervention targeting daily living skills Surviving and Thriving in the Real World - Telehealth or STRW-T intervention to a control group telehealth intervention targeting social skills Program for the Education and Enrichment of Relational Skills- Telehealth or PEERS-T The key endpoint will be change in daily living skills on primary and secondary outcome measures at the end of treatment
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 DLS 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
A total of 192 autistic adolescents between the ages of 15-21 who are in their last 2 years of high school will be randomized to the STRW-T group n96 or the PEERS-T control group n96 Outcome measures will be assessed at baseline post-treatment 6-month follow-up and 6-month post-high school graduation assessments Adolescents will meet the following inclusion criteria 1 a diagnosis of ASD 2 enrolled in 11th or 12th grade 3 Intelligence Quotient of greater than or equal to 70 and 4 a DLS deficit on the Vineland-3 interview as reported by caregivers
Aim 1 Examine the efficacy of STRW-T on DLS compared to a control group PEERS-T Hypothesis 1 STRW-T youth will have greater gains on the primary DLS assessment VABS-3 compared to PEERS-T youth at post-treatment Hypothesis 2 STRW-T youth will have greater gains on secondary DLS assessments Adaptive Behavior Assessment System 3rd Edition DLS-Goal Attainment Scale daily phone diaries compared to PEERS-T at post-treatment
Aim 2 Evaluate whether the improvement on DLS outcomes by STRW-T are sustained beyond the intervention period Hypothesis 3 The impact of STRW-T on DLS gains as assessed by primary and secondary DLS assessments will be sustained at 6-months post-treatment
Aim 3 Examine the effects of the STRW-T intervention on outcomes in college employment and Quality of Life after high school graduation Hypothesis 4 STRW-T youth will have better college employment and Quality of Life outcomes compared to PEERS-T youth at 6-months post-high school graduation
Daily living skills DLS 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
A total of 192 autistic adolescents between the ages of 15-21 who are in their last 2 years of high school will be randomized to the STRW-T group n96 or the PEERS-T control group n96 Outcome measures will be assessed at baseline post-treatment 6-month follow-up and 6-month post-high school graduation assessments Adolescents will meet the following inclusion criteria 1 a diagnosis of ASD 2 enrolled in 11th or 12th grade 3 Intelligence Quotient of greater than or equal to 70 and 4 a DLS deficit on the Vineland-3 interview as reported by caregivers
Aim 1 Examine the efficacy of STRW-T on DLS compared to a control group PEERS-T Hypothesis 1 STRW-T youth will have greater gains on the primary DLS assessment VABS-3 compared to PEERS-T youth at post-treatment Hypothesis 2 STRW-T youth will have greater gains on secondary DLS assessments Adaptive Behavior Assessment System 3rd Edition DLS-Goal Attainment Scale daily phone diaries compared to PEERS-T at post-treatment
Aim 2 Evaluate whether the improvement on DLS outcomes by STRW-T are sustained beyond the intervention period Hypothesis 3 The impact of STRW-T on DLS gains as assessed by primary and secondary DLS assessments will be sustained at 6-months post-treatment
Aim 3 Examine the effects of the STRW-T intervention on outcomes in college employment and Quality of Life after high school graduation Hypothesis 4 STRW-T youth will have better college employment and Quality of Life outcomes compared to PEERS-T youth at 6-months post-high school graduation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None