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 11 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-17.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in 50 adolescents versus other available treatment options.
This study will further examine a treatment plan for adolescents with autism spectrum disorderS (ASD) and anxiety. Many children who have an autism spectrum disorder experience substantial anxiety that can cause impairment above that of an ASD alone. Few studies have examined effective treatment options for anxiety in this population. In typically developing youth, Cognitive Behavioral Therapy (CBT) is considered the gold standard for treating anxiety. But, in order to address the unique needs of children with ASD, this study utilizes a modified CBT treatment plan which includes social skills and parent training. In our past studies, this cognitive-behavioral treatment plan has been effective in kids with ASD and anxiety compared to kids who did not receive any treatment.The current study compares this modified treatment plan to other treatment options in the community. The experimental component of this study is being assigned to 1 of 2 groups. The first group will receive CBT immediately for a period of 16 weeks. The second group will have to wait 16 weeks before receiving CBT. During this time period, children may receive any other services in the community. Overall, all adolescents receive the same type of therapy; it's matter of whether he/she receives it immediately or after a wait period. Sixteen weekly sessions comprise CBT. All therapy and assessments associated with this study will be free of charge.
Exclusion Criteria:
This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
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 16 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
Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.
Time frame: After an average of 16 weeks (Post-treatment)
Anxiety Disorders Interview Schedule Clinical Severity Rating
Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity.
Time frame: After an average of 16 weeks (Post-treatment)
Clinical Global Impression - Severity Scale
Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity.
Time frame: After an average of 16 weeks (Post-treatment)
| Milestone | Cognitive Behavioral Therapy Condition | Treatment as Usual |
|---|---|---|
| Started | 16 | 15 |
| Completed | 16 | 15 |
| Not completed | 0 | 0 |
Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.
| units on a scale | Cognitive Behavioral Therapy Condition | Treatment as Usual |
|---|---|---|
| Pediatric Anxiety Rating Scale | 10.94 ± 3.91 | 13.93 ± 3.56 |
Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity.
| units on a scale | Cognitive Behavioral Therapy Condition | Treatment as Usual |
|---|---|---|
| Anxiety Disorders Interview Schedule Clinical Severity Rating | 3.69 ± 1.35 | 5.33 ± .9 |
Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity.
| units on a scale | Cognitive Behavioral Therapy Condition | Treatment as Usual |
|---|---|---|
| Clinical Global Impression - Severity Scale | 2.88 ± .72 | 3.67 ± .82 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Behavioral Therapy Condition | — | 0/16 (0%) | 0/16 (0%) |
| Treatment as Usual | — | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Cognitive Behavioral Therapy Condition | Treatment as Usual | Total |
|---|---|---|---|
| <=18 years | 16 | 15 | 31 |
| 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 | 12.75 ± 1.24 | 12.73 ± 1.49 | 12.74 ± 1.34 |
| Sex: Female, Male(Participants) | Cognitive Behavioral Therapy Condition | Treatment as Usual | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 12 | 13 | 25 |
| Race/Ethnicity, Customized(participants) | Cognitive Behavioral Therapy Condition | Treatment as Usual | Total |
|---|---|---|---|
| Caucasian | 12 | 14 | 26 |
| Pacific Islander | 1 | 0 | 1 |
| Hispanic | 3 | 1 | 4 |
| Region of Enrollment(participants) | Cognitive Behavioral Therapy Condition | Treatment as Usual | Total |
|---|---|---|---|
| United States | 16 | 15 | 31 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of South Florida