Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05131425
Status:
RECRUITING
Last Update Posted:
2023-06-13
First Post:
2021-07-08
Brief Title:
Facing Your Fears Adolescents With ASD and Intellectual Disability
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Group Cognitive Behavioral Treatment for Anxiety in Adolescents With ASD and Intellectual Disability A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FYFASDID
Brief Summary:
Adolescents with ASD and intellectual disability ID are a complex and underserved population Approximately 50 of individuals with ASDID experience significant anxiety Yet there are very limited mental health care interventions available for this population Addressing anxiety and building coping skills is particularly important during adolescence as coping skills can support a successful transition to adulthood and family functioning during a difficult developmental period
The current investigators adapted a cognitive behavioral treatment CBT manualized intervention Facing Your Fears for adolescents with ASDID FYFASDID and completed a pilot study with 23 teens Preliminary results indicated significant improvements in anxiety and mood symptoms The proposed study seeks to test whether FYFASDID is more effective in reducing anxiety than treatment-as-usual TAU The investigators propose a Randomized Control Trial RCT with 36 adolescents with ASDID 12-18 years randomized to FYF ASDID and 36 adolescents randomized to TAU for 14 weeks The 36 teens randomized to TAU will then cross-over and complete FYFASDID Evaluations will take place at Baseline Post-Intervention and 6-month follow-up Teens in the TAU will have two baseline assessments prior to crossing over to FYFASDID both groups will complete a 6-month follow-up assessment after finishing FYFASDID
There are three aims for this project 1 examine the efficacy of FYF ASDID relative to TAU in improving anxiety as measured by parent report and determine if any gains noted in the FYFASDID are maintained at 6-month follow-up 2 examine secondary outcomes of anxiety such as how emotion regulation and problem behavior are affected by participation in FYFASDID and 3 examine whether adolescents independent use of CBT skills as assessed by goal attainment ratings of prompting level required to use strategies to manage anxiety are increased following participation in FYFASDID
The current investigators adapted a cognitive behavioral treatment CBT manualized intervention Facing Your Fears for adolescents with ASDID FYFASDID and completed a pilot study with 23 teens Preliminary results indicated significant improvements in anxiety and mood symptoms The proposed study seeks to test whether FYFASDID is more effective in reducing anxiety than treatment-as-usual TAU The investigators propose a Randomized Control Trial RCT with 36 adolescents with ASDID 12-18 years randomized to FYF ASDID and 36 adolescents randomized to TAU for 14 weeks The 36 teens randomized to TAU will then cross-over and complete FYFASDID Evaluations will take place at Baseline Post-Intervention and 6-month follow-up Teens in the TAU will have two baseline assessments prior to crossing over to FYFASDID both groups will complete a 6-month follow-up assessment after finishing FYFASDID
There are three aims for this project 1 examine the efficacy of FYF ASDID relative to TAU in improving anxiety as measured by parent report and determine if any gains noted in the FYFASDID are maintained at 6-month follow-up 2 examine secondary outcomes of anxiety such as how emotion regulation and problem behavior are affected by participation in FYFASDID and 3 examine whether adolescents independent use of CBT skills as assessed by goal attainment ratings of prompting level required to use strategies to manage anxiety are increased following participation in FYFASDID
Detailed Description:
Background Adolescents with ASD and intellectual disability ID are a complex and under-served population Anxiety occurs at higher rates in individuals with ASDID 53 than in ID alone 17 and may result in physical distress avoidance of stressful situations and problem behavior Further it frequently contributes to caregivers taking over tasks for youth with ID and limiting independence Parents voice concern about treatment options as the limited available supports often focus on prevention and accommodation of anxiety rather than on building coping skills Thus teens often finish high school with limited coping abilities and consequently experience heightened anxiety in the workplace and poor job retention Yet when coping skills are taught early in adolescence there is an opportunity to practice coping prior to transition leading to better employment rates decreased clinical service use and increased long-term wages Addressing anxiety and building coping skills for teens with ASDID is of critical importance as these are per-requisite skills for successful transition to adulthood
Intervention A significant treatment barrier for teens with ASDID is the lack of evidence based manualized interventions for this population This is due in part because youth with ASDID have typically been excluded from intervention research trials examining the effectiveness of best practice treatments such as cognitive behavioral therapy CBT Recent research adapting CBT to meet the cognitive social and behavioral needs of this population have yielded promising results and challenge the paradigm that individuals with ID are not able to access cognitive and emotion regulation strategies The research team for the present study adapted a CBT manualized intervention Facing Your Fears for adolescents with ASDID FYFASDID and completed a pilot study with 23 teens Preliminary outcome measures indicated significant improvements in anxiety and mood symptoms
Objective The current study seeks to test whether FYFASDID an adapted CBT intervention for teens with ASDID is more effective in reducing anxiety than treatment-as-usual TAU
Study Design The investigators will use a Randomized Control Trial RCT with 36 adolescents with ASDID 12-18 years randomized to FYF ASDID and 36 adolescents randomized to TAU for 14 weeks The 36 teens randomized to TAU will then cross-over and complete FYFASDID Evaluations will take place at Baseline Post-Intervention and 6-month follow-up Teens in the TAU will have two baseline assessments prior to crossing over to FYFASDID both groups will complete a 6-month follow-up assessment after finishing FYFASDID
Specific Aims Three aims are proposed 1 examine the efficacy of FYF ASDID relative to TAU in improving anxiety as measured by parent report and determine if gains are maintained at 6-month follow-up 2 examine secondary outcomes of anxiety such as how emotion regulation and problem behavior are affected by participation in FYFASDID and 3 examine whether adolescents independent use of CBT skills as assessed by goal attainment ratings of prompting level required to use strategies to manage anxiety are increased following participation in FYFASDID
Impact The present study would represent the first RCT of a CBT intervention for adolescents with ASDID a critical step toward establishing an evidence base for anxiety treatment for this underserved and vulnerable population
Translatability It is necessary to close the gap in the availability of anxiety interventions and ensure effective mental health care for all individuals on the spectrum Completing a well-designed RCT that incorporates random assignment a control group and careful measurement of anxiety is a critical next step in evaluating the effectiveness of this CBT treatment and supporting the study of interventions that can contribute to positive coping skills that allow teens to access time limited transition services and optimize outcome
Intervention A significant treatment barrier for teens with ASDID is the lack of evidence based manualized interventions for this population This is due in part because youth with ASDID have typically been excluded from intervention research trials examining the effectiveness of best practice treatments such as cognitive behavioral therapy CBT Recent research adapting CBT to meet the cognitive social and behavioral needs of this population have yielded promising results and challenge the paradigm that individuals with ID are not able to access cognitive and emotion regulation strategies The research team for the present study adapted a CBT manualized intervention Facing Your Fears for adolescents with ASDID FYFASDID and completed a pilot study with 23 teens Preliminary outcome measures indicated significant improvements in anxiety and mood symptoms
Objective The current study seeks to test whether FYFASDID an adapted CBT intervention for teens with ASDID is more effective in reducing anxiety than treatment-as-usual TAU
Study Design The investigators will use a Randomized Control Trial RCT with 36 adolescents with ASDID 12-18 years randomized to FYF ASDID and 36 adolescents randomized to TAU for 14 weeks The 36 teens randomized to TAU will then cross-over and complete FYFASDID Evaluations will take place at Baseline Post-Intervention and 6-month follow-up Teens in the TAU will have two baseline assessments prior to crossing over to FYFASDID both groups will complete a 6-month follow-up assessment after finishing FYFASDID
Specific Aims Three aims are proposed 1 examine the efficacy of FYF ASDID relative to TAU in improving anxiety as measured by parent report and determine if gains are maintained at 6-month follow-up 2 examine secondary outcomes of anxiety such as how emotion regulation and problem behavior are affected by participation in FYFASDID and 3 examine whether adolescents independent use of CBT skills as assessed by goal attainment ratings of prompting level required to use strategies to manage anxiety are increased following participation in FYFASDID
Impact The present study would represent the first RCT of a CBT intervention for adolescents with ASDID a critical step toward establishing an evidence base for anxiety treatment for this underserved and vulnerable population
Translatability It is necessary to close the gap in the availability of anxiety interventions and ensure effective mental health care for all individuals on the spectrum Completing a well-designed RCT that incorporates random assignment a control group and careful measurement of anxiety is a critical next step in evaluating the effectiveness of this CBT treatment and supporting the study of interventions that can contribute to positive coping skills that allow teens to access time limited transition services and optimize outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None