Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01563003
Other study ID # AASD-2012
Secondary ID
Status Completed
Phase N/A
First received March 22, 2012
Last updated April 15, 2015
Start date June 2011
Est. completion date April 2015

Study information

Verified date April 2015
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 16 Years
Eligibility Inclusion Criteria:

1. Outpatient children with an autism spectrum disorder (see #2 below) between the ages 11-16 years.

2. Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or PDD-NOS using scores from the Autism Diagnostic Interview-Revised and the Childhood Autism Rating Scale.

3. Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia, or obsessive compulsive disorder (OCD) as determined by the ADIS-IV-C/P (with CSR 4) and all available information.

4. Minimum score of 13 on the PARS Severity Scale; this score indicates clinically significant anxiety symptom severity (RUPP, 2002) and has been used in recent major clinical trials (e.g., Walkup et al., 2008).

5. Child has a Full Scale and Verbal Comprehension IQ > 80 as assessed on a commonly used IQ test.

6. Subjects with co-morbid depression, ADHD, tic disorder or disruptive behavior disorders will be acceptable as long as the anxiety disorder is primary (i.e., most impairing/distressing).

Exclusion Criteria:

1. Receiving concurrent psychotherapy, social skills training, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study.

2. New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.

3. Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications that might have behavioral effects must be stable for 6 weeks prior to the study baseline assessment. Any medications that the adolescent is on must remain stable during treatment. If a potential participant is taking psychotropic medication at the time of the phone evaluation or the first in-person study assessment and wishes to discontinue this medication to enter the study, the patient will be asked to discuss this option with their prescribing physician to determine whether medication discontinuation would be safe and in the adolescent's best interest. In addition, we will obtain the patient's written consent to contact their treating clinician to determine the appropriateness of study participation. We will not influence the decision patients make with their prescribing physician. All pharmacotherapy recommendations will be made in consultation with Dr. Murphy.

4. (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.

5. Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.

6. Unwillingness of parents to make the commitment to accompany their child for multiple study visits.

7. Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
Cognitive Behavioral Therapy
This condition involves 16 weekly CBT sessions.
Treatment as usual
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.

Locations

Country Name City State
United States Rothman Center for Neuropsychiatry St. Petersburg Florida

Sponsors (1)

Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pediatric Anxiety Rating Scale Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity. After an average of 16 weeks (Post-treatment) No
Secondary Anxiety Disorders Interview Schedule Clinical Severity Rating Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity. After an average of 16 weeks (Post-treatment) No
Secondary Clinical Global Impression - Severity Scale Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity. After an average of 16 weeks (Post-treatment) No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT04167839 - Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Active, not recruiting NCT06080087 - Implementation Toolkit to Enhance EBP Among Marginalized Families N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Completed NCT03206996 - Exposure Therapy for Auditory Sensitivity in Autism N/A
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Completed NCT05588570 - Coaching Children With Anxiety and Autism Through Telehealth N/A
Enrolling by invitation NCT06058104 - Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism N/A
Withdrawn NCT02414451 - Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response N/A
Completed NCT03002363 - The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance Phase 1
Completed NCT02847182 - Cord Blood Infusion for Children With Autism Spectrum Disorder Phase 2
Completed NCT02911194 - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT02508922 - Trial of Vitamin D3 Supplementation in Paediatric Autism N/A
Completed NCT02720900 - Prebiotic Intervention for Autism Spectrum Disorders N/A
Completed NCT02536365 - Sensory Integration Therapy in Autism: Mechanisms and Effectiveness N/A
Completed NCT02708290 - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Recruiting NCT01836562 - A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism Phase 1/Phase 2
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Completed NCT02154828 - Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

External Links