Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 5:10 AM
Study NCT ID:
NCT07245160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cognitive Behavioral Therapy Approach to Addressing Anxiety in Children With ASD and Intellectual Disability
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Feasibility Study of Addressing Anxiety in Children With ASD and Intellectual Disability Through the Facing Your Fears Program
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
FYF
Brief Summary:
Anxiety can be a debilitating and common concomitant diagnosis in autism spectrum disorders (ASD). Dependent on age and subtype of anxiety, the prevalence of anxiety in individuals with autism ranges between 1.7-84%. Meanwhile, the prevalence rate of intellectual disability (ID) in individuals with ASD ranges between 50-80% based on previous studies. There is an even greater risk of anxiety, ranging between 13.6- 43%, in individuals with ASD and ID. Despite the high prevalence of anxiety within this population, there are limited studies exploring assessments and treatments geared towards addressing anxiety in autism and intellectual disabilities. Previous studies have been limited to children who are identified as high functioning, or identified as low functioning without a concomitant diagnosis of ID. Given this, the present study focuses on the population of individuals with ASD and ID by exploring the feasibility of a CBT intervention designed for individuals with high-functioning autism
This pilot study aims at addressing and treating anxiety in children with ASD and intellectual disability through the Facing Your Fears (FYF) intervention. Facing Your Fears is a cognitive behavioral therapy (CBT) program specifically designed to address anxiety symptoms in children with autism. Research exploring the effectiveness of the FYF intervention within the population of individuals with ASD and ID is limited. This study aims at evaluating the feasibility of the Facing Your Fears program to address anxiety in children with ASD and ID, while evaluating the effectiveness of this intervention in larger group settings. The duration of the study will run over two 12-week cycles with study assessments conducted in-person, once a week. The study will involve 5-6 parent-child dyads to make up 10-12 participants per cycle. The child participants must be between the ages of 12-18 years old and have a confirmed diagnosis of ASD that meets DSM-V criteria. The study will commence with a month of recruitment, and a month allotted for collating data and assessments, before and after each 12-week intervention cycle. Evaluations will take place at screening, every study visit, and post intervention. Alongside the study evaluations, weekly sessions will involve didactic and practice sessions, with the last 30 minutes reserved for parent training. The sessions focus on the use and generalization of the taught strategies to address anxious symptoms, and exposure sessions outside of the weekly sessions. At the end of the 12-week cycle, the assessments related to the study outcomes will be administered again to allow investigators to compare and analyze pre- and post-intervention scores.
This pilot study aims at addressing and treating anxiety in children with ASD and intellectual disability through the Facing Your Fears (FYF) intervention. Facing Your Fears is a cognitive behavioral therapy (CBT) program specifically designed to address anxiety symptoms in children with autism. Research exploring the effectiveness of the FYF intervention within the population of individuals with ASD and ID is limited. This study aims at evaluating the feasibility of the Facing Your Fears program to address anxiety in children with ASD and ID, while evaluating the effectiveness of this intervention in larger group settings. The duration of the study will run over two 12-week cycles with study assessments conducted in-person, once a week. The study will involve 5-6 parent-child dyads to make up 10-12 participants per cycle. The child participants must be between the ages of 12-18 years old and have a confirmed diagnosis of ASD that meets DSM-V criteria. The study will commence with a month of recruitment, and a month allotted for collating data and assessments, before and after each 12-week intervention cycle. Evaluations will take place at screening, every study visit, and post intervention. Alongside the study evaluations, weekly sessions will involve didactic and practice sessions, with the last 30 minutes reserved for parent training. The sessions focus on the use and generalization of the taught strategies to address anxious symptoms, and exposure sessions outside of the weekly sessions. At the end of the 12-week cycle, the assessments related to the study outcomes will be administered again to allow investigators to compare and analyze pre- and post-intervention scores.
Detailed Description:
Autism spectrum disorder (ASD) is a neurodevelopmental condition that is characterized by social communication deficits and restricted and repetitive behaviours. Its prevalence is estimated at 1 in every 59 children or 1-2% of the population in Asia, Europe, and North America. There are about four males for every female who receives the diagnosis. While the exact cause is still unknown, it is postulated that it may be due to a combination of genetics, environmental, and epigenetic factors. There are a number of other disorders that are associated with autism spectrum disorder, such as intellectual disability, anxiety, Fragile X, and ADHD. Of these co-morbid conditions, anxiety is one of the most prevalent comorbid psychiatric problems in children with autism. Prevalence rates of anxiety in individuals with autism range between 1.7-84%, depending on age and subtype of anxiety. Meanwhile, prevalence range of intellectual disability in individuals with autism ranges between 50-80% based on previous studies. In individuals with autism and intellectual disability, there is an even greater risk of anxiety, ranging between 13.6-43%.
However, despite the high prevalence rate of anxiety within this population, there are not a lot of studies that have looked into assessments and treatment for individuals with autism and intellectual disabilities. Most studies on anxiety in autism have been in individuals without a concomitant diagnosis of intellectual disability. Only two reviews have previously evaluated therapy for anxiety in low-functioning individuals with autism, without "low-functioning" being equivalent to a diagnosis of intellectual disability. In fact, a lot of individuals with intellectual disabilities are usually found ineligible to be part of studies as a lot of assessments in these studies rely on self-reports of internal states. Limitations of cognition and communication skills may make reliability of responses to assessments challenging. Thus, while there are some interventions available to individuals with autism and intellectual disability to address their anxiety, to our knowledge, there are no studies that have looked into evaluating the effectiveness of these interventions in larger groups. There are also no studies that have looked into the feasibility of using existing interventions for addressing anxiety in autism, in children with autism and intellectual disability. Facing Your Fears program is a cognitive behavioural therapy (CBT) program specifically designed for children with autism who are experiencing anxiety. However, previous studies have been limited to children who are identified as high functioning autism. This will be a feasibility study on the use of the Facing Your Fears program in addressing anxiety in children with autism and intellectual disability.
Potential participants will be invited to join the study through assigned research staff who will introduce the study, the Facing Your Fears program, and assessed for eligibility. Once they are deemed eligible and express interest, they will be invited to come in for an appointment to discuss and sign consent and assent forms. Once the consent and assent forms are signed, the guardian will be interviewed by an assigned research staff following a screening interview. The screening and baseline phase will include a structured interview regarding the participant's medical history, and standardized questionnaires and assessments. These assessments will include:
1. SCARED/MASC-2 (parent and child report forms for anxiety symptoms)
2. CBCL (parent-reported scale used as a screening measure for internalizing and externalizing behaviours of a child (preschool and school-age), which includes measures of social deficits. CBCL subtests include anxious/depressed, withdrawn, social problems, thought problems, attention problems, somatic complaints, and aggressive and/or delinquent behaviours)
3. ADOS (standardized play assessment for autism diagnosis)
4. WASI (Weschler Abbreviated Scale for Intelligence)
5. PedsQL (brief measure of health-related quality of life in children and young people composed of generic core scales: physical functioning, emotional functioning, social functioning, and school functioning)
6. Satisfaction Questionnaire (only administered post the 12 week period) Participants who meet eligibility criteria based on inclusion/exclusion criteria will be enrolled in the study. Those who do not meet criteria will be considered a screen fail.
Following the screening/baseline period, eligible participants will be assigned to treatment groups of 5-6 child-parent dyads who will meet once a week for 1.5 hours, over a 12-week period (N=24; 12 participants per cycle). Participants will be assigned to the cycles based on the order in which they are screened and enrolled. The first 6 parent-child dyads deemed eligible will begin treatment in cycle 1. The remaining 6 parent-child dyads deemed eligible will begin treatment in cycle 2. These weekly sessions will be a combination of didactic and practice sessions, with the last 30 minutes reserved for parent training. Participants will be provided a schedule of sessions to attend. Facing Your Fears workbooks for both parent and child will be provided for use during the sessions. Assessment forms and questionnaires will also be provided for the parent to answer during this visit.
1. SCARED/MASC-2
2. CBCL
3. PedsQL
The initial session includes the introduction to anxiety, signs and symptoms, situations that can cause anxiety, and an introduction to some strategies to address anxiety. The program focuses on the use and generalization of the strategies in the sessions to address anxious symptoms, and exposure sessions outside of the sessions.
The same guardian will accompany the participant to every session to learn about anxiety disorders and the basic principles of CBT. The guardian helps identify the specific anxiety symptom of the participant to target during the study, discussion of guardian's own concerns, and the challenges in managing anxiety in the context of ASD and intellectual disability. The sessions will follow the flow set out in the Facing Your Fears workbooks as this program was specifically designed for children with autism.
At the end of the 12-week period, the MASC-2/SCARED, PedsQL, CBCL, and Satisfaction Questionnaire will be administered again. Pre- and post-intervention scores will be collected and analyzed. Outcomes of the post-intervention assessments will undergo t-test analysis comparing pre and post test results of study measures to determine statistically significant change after exposure to the intervention. The change in proportion of the participants whose scores met clinical cut-off T-scores will also be determined, by comparing pre and post intervention scores on study measures. Surveys will be completed by participant dyads to assess for the feasibility of the intervention's recruitment, intensity, frequency, and duration of the modified intervention for this new target population. The preliminary responses of the participants to the intervention will also be assessed. The study team will be analyzing if the data collection procedures and outcome measures are feasible and appropriate. A survey will also be completed by facilitators in order to determine whether the intervention and study procedures are acceptable, as well as determine potential areas of concern during implementation. Cost analyses of the study will also be completed during and at the end of the study.
This study will be asking participants and their parents to talk about their worries and fears. Talking about these topics and the gradual exposure to challenge their fears may cause distress and discomfort. To mitigate distress experienced, should the participants feel that the rate of exposure is causing too much distress, the rate of exposure may be individualized for the participants. Participants will be monitored throughout the study by the facilitators to determine possible adverse events' onset, relation to study intervention, and outcome.
However, despite the high prevalence rate of anxiety within this population, there are not a lot of studies that have looked into assessments and treatment for individuals with autism and intellectual disabilities. Most studies on anxiety in autism have been in individuals without a concomitant diagnosis of intellectual disability. Only two reviews have previously evaluated therapy for anxiety in low-functioning individuals with autism, without "low-functioning" being equivalent to a diagnosis of intellectual disability. In fact, a lot of individuals with intellectual disabilities are usually found ineligible to be part of studies as a lot of assessments in these studies rely on self-reports of internal states. Limitations of cognition and communication skills may make reliability of responses to assessments challenging. Thus, while there are some interventions available to individuals with autism and intellectual disability to address their anxiety, to our knowledge, there are no studies that have looked into evaluating the effectiveness of these interventions in larger groups. There are also no studies that have looked into the feasibility of using existing interventions for addressing anxiety in autism, in children with autism and intellectual disability. Facing Your Fears program is a cognitive behavioural therapy (CBT) program specifically designed for children with autism who are experiencing anxiety. However, previous studies have been limited to children who are identified as high functioning autism. This will be a feasibility study on the use of the Facing Your Fears program in addressing anxiety in children with autism and intellectual disability.
Potential participants will be invited to join the study through assigned research staff who will introduce the study, the Facing Your Fears program, and assessed for eligibility. Once they are deemed eligible and express interest, they will be invited to come in for an appointment to discuss and sign consent and assent forms. Once the consent and assent forms are signed, the guardian will be interviewed by an assigned research staff following a screening interview. The screening and baseline phase will include a structured interview regarding the participant's medical history, and standardized questionnaires and assessments. These assessments will include:
1. SCARED/MASC-2 (parent and child report forms for anxiety symptoms)
2. CBCL (parent-reported scale used as a screening measure for internalizing and externalizing behaviours of a child (preschool and school-age), which includes measures of social deficits. CBCL subtests include anxious/depressed, withdrawn, social problems, thought problems, attention problems, somatic complaints, and aggressive and/or delinquent behaviours)
3. ADOS (standardized play assessment for autism diagnosis)
4. WASI (Weschler Abbreviated Scale for Intelligence)
5. PedsQL (brief measure of health-related quality of life in children and young people composed of generic core scales: physical functioning, emotional functioning, social functioning, and school functioning)
6. Satisfaction Questionnaire (only administered post the 12 week period) Participants who meet eligibility criteria based on inclusion/exclusion criteria will be enrolled in the study. Those who do not meet criteria will be considered a screen fail.
Following the screening/baseline period, eligible participants will be assigned to treatment groups of 5-6 child-parent dyads who will meet once a week for 1.5 hours, over a 12-week period (N=24; 12 participants per cycle). Participants will be assigned to the cycles based on the order in which they are screened and enrolled. The first 6 parent-child dyads deemed eligible will begin treatment in cycle 1. The remaining 6 parent-child dyads deemed eligible will begin treatment in cycle 2. These weekly sessions will be a combination of didactic and practice sessions, with the last 30 minutes reserved for parent training. Participants will be provided a schedule of sessions to attend. Facing Your Fears workbooks for both parent and child will be provided for use during the sessions. Assessment forms and questionnaires will also be provided for the parent to answer during this visit.
1. SCARED/MASC-2
2. CBCL
3. PedsQL
The initial session includes the introduction to anxiety, signs and symptoms, situations that can cause anxiety, and an introduction to some strategies to address anxiety. The program focuses on the use and generalization of the strategies in the sessions to address anxious symptoms, and exposure sessions outside of the sessions.
The same guardian will accompany the participant to every session to learn about anxiety disorders and the basic principles of CBT. The guardian helps identify the specific anxiety symptom of the participant to target during the study, discussion of guardian's own concerns, and the challenges in managing anxiety in the context of ASD and intellectual disability. The sessions will follow the flow set out in the Facing Your Fears workbooks as this program was specifically designed for children with autism.
At the end of the 12-week period, the MASC-2/SCARED, PedsQL, CBCL, and Satisfaction Questionnaire will be administered again. Pre- and post-intervention scores will be collected and analyzed. Outcomes of the post-intervention assessments will undergo t-test analysis comparing pre and post test results of study measures to determine statistically significant change after exposure to the intervention. The change in proportion of the participants whose scores met clinical cut-off T-scores will also be determined, by comparing pre and post intervention scores on study measures. Surveys will be completed by participant dyads to assess for the feasibility of the intervention's recruitment, intensity, frequency, and duration of the modified intervention for this new target population. The preliminary responses of the participants to the intervention will also be assessed. The study team will be analyzing if the data collection procedures and outcome measures are feasible and appropriate. A survey will also be completed by facilitators in order to determine whether the intervention and study procedures are acceptable, as well as determine potential areas of concern during implementation. Cost analyses of the study will also be completed during and at the end of the study.
This study will be asking participants and their parents to talk about their worries and fears. Talking about these topics and the gradual exposure to challenge their fears may cause distress and discomfort. To mitigate distress experienced, should the participants feel that the rate of exposure is causing too much distress, the rate of exposure may be individualized for the participants. Participants will be monitored throughout the study by the facilitators to determine possible adverse events' onset, relation to study intervention, and outcome.
Study Oversight
Has Oversight DMC:
False
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?: