An interventional study of Cognitive Behavioral Therapy and Treatment as usual in Autism, Asperger's Syndrome and Pervasive Developmental Disorder Not Otherwise Specified, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
Autism spectrum disorders affect as many as 1 out of 88 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.
Autism spectrum disorders affect as many as 1 out of 88 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Many children with anxiety disorders, especially those on the autism spectrum, do not receive evidence based treatment, which has fueled the development and evaluation of cognitive-behavioral therapy (CBT). Accordingly, we are proposing a randomized controlled trial to examine the efficacy of exposure based CBT that heavily incorporates parents (EF-CBT) relative to a TAU condition (TAU) in 50 youth ages 6-12 years with ASD and comorbid anxiety disorder(s).
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's enrollment of 32 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.
Other: Cognitive Behavioral Therapy
This arm acts as the comparison condition. Participants randomized to this arm 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). Treatment changes (e.g., medication increase, starting psychotherapy in the 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.
Other: Treatment as usual
This condition involves 12 weekly CBT sessions.
This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
Pediatric Anxiety Rating Scale
This scale measures the severity of anxiety symptoms in children. The total scale range is 0-30 where 0 is the minimum and 30 the maximum. Higher scores correspond to more severe anxiety symptom severity. The total scale was used which corresponds to summing the 6 severity items. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual).
Time frame: After an average of 12 weeks (post-treatment)
Clinical Global Impression - Severity Scale
This scale measures the severity of anxiety symptoms in children. The total scale range is 0-6 where 0 is the minimum and 6 the maximum. Higher scores correspond to more severe anxiety symptom severity. The scale consists of only 1 item that a clinician rates based on their judgement of anxiety severity. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual).
Time frame: After an average of 12 weeks (Post-treatment)
| Milestone | Cognitive Behavioral Therapy Condition | Treatment as Usual |
|---|---|---|
| Started | 14 | 18 |
| Completed | 11 | 18 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
This scale measures the severity of anxiety symptoms in children. The total scale range is 0-30 where 0 is the minimum and 30 the maximum. Higher scores correspond to more severe anxiety symptom severity. The total scale was used which corresponds to summing the 6 severity items. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual).
| units on a scale | Cognitive Behavioral Therapy Condition | Treatment as Usual |
|---|---|---|
| Pediatric Anxiety Rating Scale | 7.79 ± 5.37 | 15.06 ± 3.21 |
This scale measures the severity of anxiety symptoms in children. The total scale range is 0-6 where 0 is the minimum and 6 the maximum. Higher scores correspond to more severe anxiety symptom severity. The scale consists of only 1 item that a clinician rates based on their judgement of anxiety severity. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual).
| units on a scale | Cognitive Behavioral Therapy Condition | Treatment as Usual |
|---|---|---|
| Clinical Global Impression - Severity Scale | 2.25 ± .87 | 3.67 ± .69 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Behavioral Therapy Condition | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Treatment as Usual | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Cognitive Behavioral Therapy Condition | Treatment as Usual | Total |
|---|---|---|---|
| <=18 years | 14 | 18 | 32 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Cognitive Behavioral Therapy Condition | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 10.07 ± 2.89 | 10 ± 2.83 | 10.03 ± 2.81 |
| Sex: Female, Male(Participants) | Cognitive Behavioral Therapy Condition | Treatment as Usual | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 10 | 16 | 26 |
| Region of Enrollment(participants) | Cognitive Behavioral Therapy Condition | Treatment as Usual | Total |
|---|---|---|---|
| United States | 14 | 18 | 32 |
The record gives a start of Aug 2013, a primary completion of Aug 2016 and a completion of Aug 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2019, 2 years 10 months after primary completion.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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