Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593613
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Pilot Trial of the RUBI Program for Autistic Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Randomized Trial of the RUBI Program for Families of Autistic Adults
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:
RUBI-A
Brief Summary:
The goal of this clinical trial is to evaluate if a redesigned version of the RUBI parenting intervention can reduce challenging behaviors and improve adaptive skills in autistic adults with co-occurring challenging behaviors The main questions it aims to answer are
Is the redesigned RUBI intervention feasible and acceptable for autistic adults and their families
Does the redesigned RUBI intervention reduce challenging behaviors and enhance the quality of life for autistic adults
Researchers will compare the redesigned RUBI intervention to an active control group Introduction to the Science and Lived Experience of Autism ISLEA to see if RUBI is more effective in improving outcomes for autistic adults and their families
Participants will
Attend sessions where they receive either the RUBI intervention or the ISLEA program
Engage in activities designed to promote communication co-regulation and autonomy in the context of supporting autistic adults
Complete assessments at the start throughout and at the end of the 20-week trial to evaluate outcomes such as challenging behaviors adaptive skills and quality of life
Is the redesigned RUBI intervention feasible and acceptable for autistic adults and their families
Does the redesigned RUBI intervention reduce challenging behaviors and enhance the quality of life for autistic adults
Researchers will compare the redesigned RUBI intervention to an active control group Introduction to the Science and Lived Experience of Autism ISLEA to see if RUBI is more effective in improving outcomes for autistic adults and their families
Participants will
Attend sessions where they receive either the RUBI intervention or the ISLEA program
Engage in activities designed to promote communication co-regulation and autonomy in the context of supporting autistic adults
Complete assessments at the start throughout and at the end of the 20-week trial to evaluate outcomes such as challenging behaviors adaptive skills and quality of life
Detailed Description:
Over the past decade across three large-scale NIH-funded trials the Research Unit in Behavioral Interventions RUBI Autism Network developed and systematically tested a low-intensity manualized parenting intervention for autistic children ages 3-14 with challenging behaviors8-10 RUBI teaches families how to foster home environments that support their autistic child including teaching parents how to understand their childs behaviors as forms of communication respond and adapt to their childs unique needs and personalize strategies for their childs needs and preferences eg utilizing visual supports to align with information processing needs attuning to the negative impact of unpredictable expectations accommodating sensory needs RUBI also may be a promising approach to support families as they provide care and support to their autistic adult dependents
RUBI has been found to be acceptable to families reliably delivered by trained therapists and effective in reducing challenging behaviors and increasing adaptive skills in children8-10 In response to the shortage of efficacious interventions for autistic adults RUBI could serve to be systematically redesigned to better support collaboration between family members and their autistic adult dependents thereby helping autistic adults lead more meaningful and independent lives To this end RUBI was recently redesigned utilizing the Discover DesignBuild Test DDBT Framework11 which leverages user-centered design participatory action research and implementation science to ensure that a modified intervention meets the needs of end users parents autistic adults community providers and is viable across contexts home community Redesign targets included 1 changes in text examples in-session activities and language to be more acceptable and relevant to the autistic adult population 2 content modifications to align focus on supporting communication and dyad co-regulation 3 improvement in inclusionary and collaborative engagement strategies and 4 promotion of the autistic adults engagement autonomy and agency during sessions and when implementing strategies
With the Discover DesignBuild phases successfully completed a two-year pilot randomized trial will extend our work to the Test phase in order to evaluate the feasibility acceptability and efficacy of the newly redesigned RUBI intervention compared to an active control - Introduction to the Science and Lived Experience of Autism ISLEA Eighty autistic adults with co-occurring challenging behaviors and their parents will be randomized 11 to either RUBI or ISLEA and followed for 20 weeks in order to evaluate key outcomes including feasibility and acceptability of the redesigned RUBI intervention This study will also explore the impact of RUBI on autistic adults challenging behaviors adaptive skills and quality of life as well as parent self-efficacy Successful completion of this proposed pilot study will allow for a future large-scale effectiveness trial of RUBI with autistic adults and their parents
RUBI has been found to be acceptable to families reliably delivered by trained therapists and effective in reducing challenging behaviors and increasing adaptive skills in children8-10 In response to the shortage of efficacious interventions for autistic adults RUBI could serve to be systematically redesigned to better support collaboration between family members and their autistic adult dependents thereby helping autistic adults lead more meaningful and independent lives To this end RUBI was recently redesigned utilizing the Discover DesignBuild Test DDBT Framework11 which leverages user-centered design participatory action research and implementation science to ensure that a modified intervention meets the needs of end users parents autistic adults community providers and is viable across contexts home community Redesign targets included 1 changes in text examples in-session activities and language to be more acceptable and relevant to the autistic adult population 2 content modifications to align focus on supporting communication and dyad co-regulation 3 improvement in inclusionary and collaborative engagement strategies and 4 promotion of the autistic adults engagement autonomy and agency during sessions and when implementing strategies
With the Discover DesignBuild phases successfully completed a two-year pilot randomized trial will extend our work to the Test phase in order to evaluate the feasibility acceptability and efficacy of the newly redesigned RUBI intervention compared to an active control - Introduction to the Science and Lived Experience of Autism ISLEA Eighty autistic adults with co-occurring challenging behaviors and their parents will be randomized 11 to either RUBI or ISLEA and followed for 20 weeks in order to evaluate key outcomes including feasibility and acceptability of the redesigned RUBI intervention This study will also explore the impact of RUBI on autistic adults challenging behaviors adaptive skills and quality of life as well as parent self-efficacy Successful completion of this proposed pilot study will allow for a future large-scale effectiveness trial of RUBI with autistic adults and their parents
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