An interventional study of Personalized Cognitive-behavioral therapy and Standard Practice Cognitive-behavioral therapy in Autism Spectrum Disorders, Autism and Asperger's Syndrome, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 7 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.
Autism spectrum disorders (ASD) are common neurodevelopmental syndromes affecting 1% of U.S. children. Comorbid anxiety disorders affect 40 to 50% of children with ASD, causing substantial distress and impairment over and above that caused by ASD alone. Although standard practice cognitive-behavioral therapy (CBT) has been established as an efficacious and safe treatment for anxiety disorders among typically developing youth, its utility in comorbid cases with ASD remains unknown. To date, no studies have experimentally compared standard practice CBT to a cognitive-behavioral intervention that has been personalized for children with a comorbid presentation of anxiety and ASD. Accordingly, we are proposing a randomized controlled trial to be conducted at three treatment sites to evaluate the efficacy of personalized CBT for anxiety in ASD (Behavioral Intervention for Anxiety in Children with Autism: BIACA) relative to standard practice CBT for anxiety (Coping Cat program). Furthermore, this study will employ a waitlist control group to assess the efficacy of each CBT arm relative to the absence of treatment (i.e., a Waitlist control arm). The proposed research will: (1) examine the efficacy of BIACA relative to Coping Cat, which represents standard practice treatment, and the efficacy of both these treatments relative to a waitlist control group, (2) evaluate the maintenance of treatment gains, (3) examine the impact of personalized intervention on functional outcomes. A total of 201youth across 3 study locations (ages 8-13 years) with ASD and co-occurring anxiety will be randomly assigned to one of the three conditions. The three recruitment sites for this study are University of California, Los Angeles, the University of South Florida (USF), and Temple University. Considering the rising number of children diagnosed with ASD together with the frequency and severity of comorbid anxiety, the proposed work is tailored to the unique needs of youth with ASD and will provide a timely contribution to public health efforts.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's enrollment of 214 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
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Exclusion Criteria:
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Clinically significant
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Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Behavioral: Personalized Cognitive-behavioral therapy
Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Behavioral: Standard Practice Cognitive-behavioral therapy
Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Behavioral: Treatment as Usual
Also known as: Behavioral Interventions for Anxiety in Children with Autism
Also known as: Coping Cat
Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.
This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.
Time frame: Baseline and After 16 Weeks of Treatment
Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale
The Clinical Global Impressions-Improvement scale (CGI-I) was completed by a clinician after 16 weeks of treatment. The CGI-I assesses the severity of anxiety on a 7 point scale, ranging from 1 (very much improved) to 7 (very much worse). A rating of 1 or 2 on the CGI-I designated a positive treatment response.
Time frame: After 16 weeks of treatment
Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment.
The Child Behavior Checklist (CBCL) is completed by parents and the anxiety/depression subscale of the CBCL was used to assess anxiety/depression symptomatology. The CBCL anxiety/depression subscale is rated on a 3-point scale, ranging from 0 (Not true) to 2 (Very True), with higher scores indicating more symptoms.
Time frame: Baseline and After 16 weeks of treatment
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
The Childhood Anxiety Impact Scale (CAIS) is a questionnaire completed by parents about the impact of the child's anxiety on functioning in three situational categories (i.e., school, social, and family functioning). The CAIS is rated on a 4-point scale, ranging from 0 (not at all) to 3 (very much). The CAIS items are summed and sorted into 3 subscales, corresponding to each situational category: school, social, and family. For all 3 subscales, higher scores correspond to more associated impact in that area.
Time frame: Baseline and After 16 weeks of treatment
Two-hundred and fourteen children between 7-13 years (M=9.96, SD=1.76) were recruited through referrals, advertisements, and the patient flow of three university-based mental health clinics. Recruitment began April 2014 and final data were collected around January 2017.
| Milestone | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual |
|---|---|---|---|
| Started | 77 | 71 | 19 |
| Completed | 67 | 59 | 15 |
| Not completed | 10 | 12 | 4 |
This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.
| units on a scale | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual |
|---|---|---|---|
| Baseline | 3.43 ± 0.48 | 3.47 ± 0.47 | 3.28 ± 0.39 |
| Post-treatment | 2.13 ± 0.91 | 2.43 ± 0.70 | 2.93 ± 0.59 |
The Clinical Global Impressions-Improvement scale (CGI-I) was completed by a clinician after 16 weeks of treatment. The CGI-I assesses the severity of anxiety on a 7 point scale, ranging from 1 (very much improved) to 7 (very much worse). A rating of 1 or 2 on the CGI-I designated a positive treatment response.
| percentage of participants | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual |
|---|---|---|---|
| Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale | 92.42 | 81.03 | 11.11 |
The Child Behavior Checklist (CBCL) is completed by parents and the anxiety/depression subscale of the CBCL was used to assess anxiety/depression symptomatology. The CBCL anxiety/depression subscale is rated on a 3-point scale, ranging from 0 (Not true) to 2 (Very True), with higher scores indicating more symptoms.
| units on a scale | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual |
|---|---|---|---|
| Baseline | 0.83 ± 0.39 | 0.88 ± 0.39 | 0.73 ± 0.28 |
| Post-treatment | 0.51 ± 0.29 | 0.69 ± 0.34 | 0.77 ± 0.27 |
The Childhood Anxiety Impact Scale (CAIS) is a questionnaire completed by parents about the impact of the child's anxiety on functioning in three situational categories (i.e., school, social, and family functioning). The CAIS is rated on a 4-point scale, ranging from 0 (not at all) to 3 (very much). The CAIS items are summed and sorted into 3 subscales, corresponding to each situational category: school, social, and family. For all 3 subscales, higher scores correspond to more associated impact in that area.
| units on a scale | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual |
|---|---|---|---|
| Baseline - CAIS School | 1.38 ± 0.61 | 1.48 ± 0.60 | 1.19 ± 0.70 |
| Post - CAIS School | 0.77 ± 0.57 | 0.88 ± 0.54 | 1.24 ± 0.51 |
| Baseline - CAIS Social | 0.97 ± 0.56 | 0.96 ± 0.62 | 0.70 ± 0.54 |
| Post - CAIS Social | 0.49 ± 0.42 | 0.65 ± 0.54 | 0.80 ± 0.50 |
| Baseline - CAIS Family | 1.16 ± 0.63 | 1.12 ± 0.62 | 0.98 ± 0.44 |
| Post - CAIS Family | 0.65 ± 0.49 | 0.73 ± 0.51 | 0.88 ± 0.60 |
Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Personalized Cognitive-behavioral Therapy | 0/77 (0%) | 0/77 (0%) | 0/77 (0%) |
| Standard Practice Cognitive-behavioral Therapy | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| Treatment as Usual | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| <=18 years | 77 | 71 | 19 | 167 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| Mean | 9.71 ± 1.86 | 10.03 ± 1.66 | 10.05 ± 1.75 | 9.90 ± 1.78 |
| Sex: Female, Male(Participants) | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| Female | 21 | 12 | 0 | 33 |
| Male | 56 | 59 | 19 | 134 |
| Race (NIH/OMB)(Participants) | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 0 | 3 |
| Asian | 6 | 3 | 1 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 2 | 3 | 11 |
| White | 58 | 57 | 13 | 128 |
| More than one race | 0 | 4 | 1 | 5 |
| Unknown or Not Reported | 5 | 4 | 1 | 10 |
| Region of Enrollment(participants) | Personalized Cognitive-behavioral Therapy | Standard Practice Cognitive-behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| United States | 77 | 71 | 19 | 167 |
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