Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537128
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Internet-delivered Cognitive-Behavioral Therapy for Adolescents with Autism and Anxiety
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Internet-delivered Cognitive-Behavioral Therapy for Adolescents with Autism and Anxiety Development and Evaluation of Learning to Understand and Navigate Anxiety-Adolescent
Status:
NOT_YET_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:
LUNA-A
Brief Summary:
Anxiety is very common in autistic youth Cognitive behavioral therapy CBT is the recommended treatment for both autistic and typically-developing TD youth with anxiety yet most families cannot access CBT due to cost practicalities of attending in-person treatment sessions and a shortage of trained providers especially in rural areas The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model
Detailed Description:
Autism affects 2-3 of youth approximately half of whom experience a co-occurring anxiety disorder Anxiety disorders in autistic youth are associated with significant life impairment and worsening trajectory without treatment Cognitive behavioral therapy CBT is the recommended treatment for both autistic and typically-developing TD youth with anxiety yet most families cannot access CBT due to cost practicalities of attending in-person treatment sessions and a shortage of trained providers especially in rural areas Access to CBT is particularly limited for Hispanic or Spanish-speaking families due to lack of services provided in Spanish Internet-delivered therapies such as iCBT provide low intensity but effective intervention and overcomes barriers such as cost travel time from workschool and stigma Studies suggest that iCBT protocols for anxious typically-developing youth demonstrate moderate to strong effect sizes relative to control groups However until recently such treatment models have not been developed with stakeholder engagement to be personalized for autistic children with anxiety and their families including for those families that speak Spanish In a previous Texas Higher Education Coordinating Board THECB funded work a parent-led iCBT intervention for anxiety among autistic youth Learning to Understand and Navigate Anxiety LUNA was developed Over 60 of participants demonstrated response to treatment yet children responded better than adolescents Family feedback indicated that the materials were not developmentally appropriate for adolescents necessitating further efforts to develop and evaluate an adapted version which is personalized to the unique needs of autistic adolescents with anxiety The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model LUNA-Adolescent This treatment model developed by the study team consists of an interactive website with both parent- and adolescent-facing treatment materials supported by brief therapist contact eg telehealth sessions both in English and Spanish Specifically this project will evaluate the efficacy and cost effectiveness of LUNA-Adolescent compared to standard-care CBT for anxiety Overall this study will provide important information regarding the potential benefits of internet-based parent-led interventions for autistic adolescents with anxiety and its two different delivery models
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