AutismNCT02225808
Neural Mechanisms of CBT for Anxiety in Autism (Open Pilot Study)
A study testing CBT for anxiety in autism in people with Autism and Autism Spectrum Disorder, run by Yale University at 1 site in United States.
Trial summary
This is an open, pilot study of neural mechanisms of cognitive-behavioral therapy for anxiety in children with high-functioning autism spectrum disorder (ASD). In addition to the core symptoms, approximately forty percent of children with ASD exhibit clinically significant levels of anxiety. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder, Anxiety
- What is being tested?
- CBT for anxiety in autism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females, ages 8 to 14 inclusive.
- DSM-V diagnosis of autism spectrum disorder.
- DSM-V diagnosis of generalized anxiety disorder, separation anxiety disorder, or social phobia.
- Score > 19 on the 20 Item Anxiety scale of the Child and Adolescent Symptom Inventory.
- Full Scale IQ and Verbal IQ > 70.
- Unmedicated or on stable medication for irritability, ADHD, anxiety, or depression for at least 6 weeks, with no planned changes for duration of study.
Show all 9Show fewer
- 7. Subjects will be free of metal medical implants, and will have a body weight of less than 250 lbs. and no claustrophobia. [These are necessitated by the safety requirements of the fMRI.]
- 8. Child is an English speaker.
- 9. Child is able to meet fMRI data quality requirements at baseline [to enable pre- to post-treatment comparison.]
Who cannot join
- Presence of a known serious medical condition in the child (based on medical history or parent report) that would interfere with child and parent's ability to participate in the study.
- Presence of a current psychiatric diagnosis in the child that would require alternative treatment (based on assessment by experienced study clinician).
- Previous treatment with four or more sessions of CBT for anxiety. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine, Child Study Center
New Haven, Connecticut, 06520
About this study
Official title: Neural Mechanisms of Cognitive-Behavioral Therapy for Anxiety in Children With Autism Spectrum Disorder: A Pilot Study
This is an open, pilot study of neural mechanisms of cognitive-behavioral therapy for anxiety in children with high-functioning autism spectrum disorder (ASD). In addition to the core symptoms, approximately forty percent of children with ASD exhibit clinically significant levels of anxiety. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in children with high-functioning ASD, but the neural mechanisms of this treatment have not been studied. CBT teaches emotion regulation skills such as cognitive reappraisal, followed by behavioral exposure to anxiety-provoking situations. The investigators propose to investigate the neural mechanisms of CBT for anxiety by evaluating fMRI indices of socioemotional functioning before and after treatment in children, ages 8 to 14, with high-functioning ASD. Dysfunction of the amygdala and its connectivity with prefrontal cortex has been implicated in co-occurring ASD and anxiety. In the investigators research, compared to typically developing controls, children with ASD have shown lower activation in several regions of prefrontal cortex and a lack of down-regulation in the amygdala during a task of emotion regulation. Based on these observations, the investigators propose that a positive response to CBT for anxiety in children with ASD will be associated with increased activation of several regions in the prefrontal cortex as well as increased functional connectivity between prefrontal regions the amygdala during the task of emotion regulation. The primary aim of this pilot study is to examine the effects of CBT on the neural basis of anxiety in ASD by collecting fMRI data during emotion regulation, face perception, and rest before and after treatment. The investigators hypothesize that CBT will increase prefrontal activity, decrease amygdala reactivity, and enhance amygdala-prefrontal functional connectivity during emotion regulation. The investigators also hypothesize that CBT will decrease amygdala reactivity during perception of emotional faces. Additional analyses will be conducted to explore change in resting-state functional connectivity before and after CBT for anxiety in children with ASD.
- Conditions
- Autism, Autism Spectrum Disorder, Anxiety
- Being tested
- CBT for anxiety in autism
- Keywords
- CBT, autism, anxiety, treatment, fMRI
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for anxiety in autismBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CBT for anxiety in autism | Experimental | Cognitive-behavioral therapy (CBT) teaches skills for coping with anxiety and consist of 12 weekly sessions. CBT is conducted with child and parent. Receives: Behavioral: CBT for anxiety in autism |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional magnetic resonance imaging (fMRI)
fMRI scanning with tasks of emotion regulation and social perception
Measured: baseline (week 0)
functional magnetic resonance imaging (fMRI)
fMRI scanning with tasks of emotion regulation and social perception
Measured: endpoint (week 12)
Secondary outcomes (4)
Multidimensional anxiety scale for children (MASC)
parent rating of child anxiety
Measured: baseline (week 0)
Multidimensional anxiety scale for children (MASC)
parent rating of child anxiety
Measured: endpoint (week 12)
Pediatric Anxiety Rating Scale (PARS)
clinician rating of anxiety based on an interview with parent and child
Measured: baseline (week 0)
Pediatric Anxiety Rating Scale (PARS)
clinician rating of anxiety based on an interview with parent and child
Measured: endpoint (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Sukhodolsky, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225808
- Sponsor's protocol ID
- 1211011144
- Status last verified
- Jan 2020
- First submitted
- 19 Aug 2014
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sukhodolsky DG, Bloch MH, Panza KE, Reichow B. Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1341-50. doi: 10.1542/peds.2013-1193. Epub 2013 Oct 28.
PubMed 24167175Sukhodolsky DG, Scahill L, Gadow KD, Arnold LE, Aman MG, McDougle CJ, McCracken JT, Tierney E, Williams White S, Lecavalier L, Vitiello B. Parent-rated anxiety symptoms in children with pervasive developmental disorders: frequency and association with core autism symptoms and cognitive functioning. J Abnorm Child Psychol. 2008 Jan;36(1):117-28. doi: 10.1007/s10802-007-9165-9. Epub 2007 Aug 3.
PubMed 17674186
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Cognitive-Behavioral Therapy for Anxiety in Children With Autism Spectrum Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT02225808
- Acronym / sponsor ID
- 1211011144
- Conditions
- Autism, Autism Spectrum Disorder, Anxiety
- Keywords
- CBT, autism, anxiety, treatment, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open, pilot study of neural mechanisms of cognitive-behavioral therapy for anxiety in children with high-functioning autism spectrum disorder (ASD). In addition to the core symptoms, approximately forty percent of children with ASD exhibit clinically significant levels of anxiety. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in children with high-functioning ASD, but the neural mechanisms of this treatment have not been studied. CBT teaches emotion regulation skills such as cognitive reappraisal, followed by behavioral exposure to anxiety-provoking situations. The investigators propose to investigate the neural mechanisms of CBT for anxiety by evaluating fMRI indices of socioemotional functioning before and after treatment in children, ages 8 to 14, with high-functioning ASD. Dysfunction of the amygdala and its connectivity with prefrontal cortex has been implicated in co-occurring ASD and anxiety. In the investigators research, compared to typically developing controls, children with ASD have shown lower activation in several regions of prefrontal cortex and a lack of down-regulation in the amygdala during a task of emotion regulation. Based on these observations, the investigators propose that a positive response to CBT for anxiety in children with ASD will be associated with increased activation of several regions in the prefrontal cortex as well as increased functional connectivity between prefrontal regions the amygdala during the task of emotion regulation. The primary aim of this pilot study is to examine the effects of CBT on the neural basis of anxiety in ASD by collecting fMRI data during emotion regulation, face perception, and rest before and after treatment. The investigators hypothesize that CBT will increase prefrontal activity, decrease amygdala reactivity, and enhance amygdala-prefrontal functional connectivity during emotion regulation. The investigators also hypothesize that CBT will decrease amygdala reactivity during perception of emotional faces. Additional analyses will be conducted to explore change in resting-state functional connectivity before and after CBT for anxiety in children with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT for anxiety in autism | Experimental | Behavioral: CBT for anxiety in autismCognitive-behavioral therapy (CBT) teaches skills for coping with anxiety and consist of 12 weekly sessions. CBT is conducted with child and parent. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Males and females, ages 8 to 14 inclusive.
- DSM-V diagnosis of autism spectrum disorder.
- DSM-V diagnosis of generalized anxiety disorder, separation anxiety disorder, or social phobia.
- Score > 19 on the 20 Item Anxiety scale of the Child and Adolescent Symptom Inventory.
- Full Scale IQ and Verbal IQ > 70.
Key exclusion criteria (3 listed)
- Presence of a known serious medical condition in the child (based on medical history or parent report) that would interfere with child and parent's ability to participate in the study.
- Presence of a current psychiatric diagnosis in the child that would require alternative treatment (based on assessment by experienced study clinician).
- Previous treatment with four or more sessions of CBT for anxiety. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT for anxiety in autism | Behavioural | CBT for anxiety in autism |
Primary outcome
functional magnetic resonance imaging (fMRI)
Time frame: baseline (week 0)
fMRI scanning with tasks of emotion regulation and social perception
functional magnetic resonance imaging (fMRI)
Time frame: endpoint (week 12)
fMRI scanning with tasks of emotion regulation and social perception
4 secondary outcomes
Multidimensional anxiety scale for children (MASC)
Time frame: baseline (week 0)
Multidimensional anxiety scale for children (MASC)
Time frame: endpoint (week 12)
Pediatric Anxiety Rating Scale (PARS)
Time frame: baseline (week 0)
Pediatric Anxiety Rating Scale (PARS)
Time frame: endpoint (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Background: PubMed 24167175Sukhodolsky DG, Bloch MH, Panza KE, Reichow B. Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1341-50. doi: 10.1542/peds.2013-1193. Epub 2013 Oct 28.
- Background: PubMed 17674186Sukhodolsky DG, Scahill L, Gadow KD, Arnold LE, Aman MG, McDougle CJ, McCracken JT, Tierney E, Williams White S, Lecavalier L, Vitiello B. Parent-rated anxiety symptoms in children with pervasive developmental disorders: frequency and association with core autism symptoms and cognitive functioning. J Abnorm Child Psychol. 2008 Jan;36(1):117-28. doi: 10.1007/s10802-007-9165-9. Epub 2007 Aug 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Sukhodolsky, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for anxiety in autism in people with Autism and Autism Spectrum Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional magnetic resonance imaging (fMRI) (time frame: baseline (week 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.