Anxiety Disorder of ChildhoodNCT03032926
A Pilot Study of Fear Extinction Learning in Anxious Youth
An observational study of Anxiety Disorder of Childhood, run by Weill Medical College of Cornell University.
Trial summary
The goal of this proposed study is to identify a potential biobehavioral marker of CBT outcome in the most common child and adolescent anxiety disorders, including separation anxiety disorder (SAD), social phobia (SoP), and generalized anxiety disorder (GAD), and to replicate in a clinical sample the previous finding… Read more about this study
- Who is it for?
- Ages 7 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder of Childhood
- What is being tested?
- Open Trial
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jul 2016
- Phase
- Observational
- 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 7 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Youth with anxiety disorders ages 7-25
Who may be able to join
- Ages 7-25 years inclusively (i.e., must be at least 7 years) at the point of consent
- Primary DSM 5 diagnosis of SepAD, SocAD, OCD, specific phobia, or panic disorder on the ADIS-IV-C/P
- Anxiety severity of moderate or greater (CGI-S >3 and functional impairment (CGAS score 60)
Who cannot join
- Estimated child Full Scale IQ < 80, as measured by the vocabulary and block design subtests of the WISC-III) (Gate B). If a potential subject has a verified IQ score in the three years prior to enrollment as measured by the WISC-III, IIIR, K-ABC, or Stanford-Binet no IQ assessment is required.
- Child meets criteria for current primary or co-primary major depressive disorder, conduct disorder or substance abuse
- Child meets criteria for Major Depressive Disorder at greater severity than anxiety disorder (Gate B)
- Subjects with the following lifetime psychiatric disorders will be excluded: bipolar disorder, PDD (Asperger's, autism), MDD with psychosis, schizophrenia, and schizoaffective disorder
- Current use of psychotropic medication or clinical indication for use of psychotropic medication (except for youth entering on a stable psychostimulant regimen for ADHD)
- Recent treatment with psychotropic medication within 6 weeks of study entry for fluoxetine, within 2 weeks for other SSRIs, and within 4 weeks for neuroleptics (Gates A, B).
Show all 14Show fewer
- Child has failed an adequate trial of CBT for anxiety within the previous 2 years (at least 10 treatment sessions over a period of less than 1 year conducted by a licensed provider of CBT)
- Child has a major neurological disorder, a major medical illness or hearing impairment that requires a prohibited episodic or chronic systemic medication or that would interfere
- Child is pregnant as indicated by history or a positive pregnancy test at Gate B. Sexually active girls must agree to use an effective form of birth control, either hormonal (BCP, Depo-Provera or Norplant), spermicide (foam or vaginal suppository) or a barrier method (condoms, diaphragm, cervical cap) or a combination of barrier/spermicide contraception in order to participate in the study.
- Child poses a significant risk for dangerousness to self or to others
- Child or parent is non-English speaking (unable to complete measures, IE ratings or treatment without the assistance of a translator) NYSPI and UCLA may recruit Spanish speaking subjects.
- Child is a victim of ongoing or previously undisclosed child abuse requiring new department of social service report or ongoing department of social service supervision
- Child, for any reason, has missed more than 50% of school days in the 2 months preceding randomization. Home schooling does not require exclusion from the study under this exclusion criterion. Ambiguous cases are referred to Caseness Panel to avoid truncating the severity range differently across sites
- Child has a history of seizures
About this study
Official title: Enhancing Specificity and Predictability of CBT Outcome for Pediatric Anxiety Disorders: A Pilot Test of a Potential Biomarker for Treatment Response Across Development
The goal of this proposed study is to identify a potential biobehavioral marker of CBT outcome in the most common child and adolescent anxiety disorders, including separation anxiety disorder (SAD), social phobia (SoP), and generalized anxiety disorder (GAD), and to replicate in a clinical sample the previous finding from animal and non-clinical human samples that a difference exists in extinction learning across development.
Read the detailed description
Study Sample and Design: The study will utilize an open treatment pilot trial design. Participants will include 10 individuals, ages 11-18, with a primary anxiety disorder diagnosis. Participants must not have failed prior trials of CBT. Participants on psychiatric medication must be on a stable dose for at least 2 months prior to study participation and remain symptomatic to the level identified for study inclusion (ADIS CSR ≥ 4).
Measures: Independent evaluators will administer a comprehensive assessment at baseline and post-treatment. The Anxiety Disorder Interview Schedule for Children for DSM-5 (ADIS-C-5)19 will measure the primary outcome of change in clinical severity of anxiety disorder symptoms across age groups. The Clinical Global Impression Scale (CGI) will assess overall symptom severity. The PARS and the MASC will provide secondary, dimensional measures of anxiety. In addition, we will measure treatment adherence and parent engagement as important secondary variables.
Fear Conditioning \& Extinction Paradigm: Subjects will participate in a laboratory test of extinction training prior to CBT in order to establish extinction learning as a potential predictive marker of treatment outcome. Subjects will be exposed to two shapes on a computer screen, one shape (conditioned stimulus (CS+) will be paired with an aversive sound (unconditioned stimulus) on 38% of the trials, whereas the other shape will never be paired with aversive sound (CS-)20. A day later, individuals will undergo extinction training in which the two conditioned stimuli will be repeatedly presented without the unconditioned stimulus. Extinction will be measured as the difference score of skin conductance response to the CS+ and CS-.
Exposure Therapy Intervention: investigators will offer participants an 8 session exposure therapy intervention. Session one will consist of psychoeducation and completion of an exposure hierarchy. Sessions 2-7 will consist of weekly gradual exposure sessions. Session 8 will include review, relapse prevention and referral to additional treatment if needed. Assessment measures will be given at the completion of each exposure session to assess individual differences in symptom change related to exposure therapy. All treatment sessions will be videotaped to ensure fidelity to treatment manual and modules.
Data analysis plan: Investigators will track the monthly number of participants screened and enrolled to determine feasibility of a larger trial, as well as session attendance, study attrition, treatment adherence and patient safety to assess acceptability of the selected measures and interventions. Though this pilot will not be adequately powered to detect statistical significance, the investigators will execute a preliminary test of the association between performance on the extinction learning task and treatment outcome, and the investigators will assess age group differences in extinction learning and treatment outcome to determine early proof of concept.
- Conditions
- Anxiety Disorder of Childhood
- Being tested
- Open Trial
- Keywords
- Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open TrialBehavioural
Behavioral Intervention
| Study group | Role | What they receive |
|---|---|---|
| Open Trial | N/A - Open Trial Receives: Behavioral: Open Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADIS Evaluation
Anxiety Disorders Interview Schedule for DSM-5-Adult Version
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder of ChildhoodStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon Bennett, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032926
- Sponsor's protocol ID
- 1310014441
- Status last verified
- Apr 2019
- First submitted
- 23 Jan 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Specificity and Predictability of CBT Outcome for Pediatric Anxiety Disorders: A Pilot Test of a Potential Biomarker for Treatment Response Across Development
- ClinicalTrials.gov ID
- NCT03032926
- Acronym / sponsor ID
- 1310014441
- Conditions
- Anxiety Disorder of Childhood
- Keywords
- Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Jan 2017 (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.
The goal of this proposed study is to identify a potential biobehavioral marker of CBT outcome in the most common child and adolescent anxiety disorders, including separation anxiety disorder (SAD), social phobia (SoP), and generalized anxiety disorder (GAD), and to replicate in a clinical sample the previous finding from animal and non-clinical human samples that a difference exists in extinction learning across development.
Detailed description
Study Sample and Design: The study will utilize an open treatment pilot trial design. Participants will include 10 individuals, ages 11-18, with a primary anxiety disorder diagnosis. Participants must not have failed prior trials of CBT. Participants on psychiatric medication must be on a stable dose for at least 2 months prior to study participation and remain symptomatic to the level identified for study inclusion (ADIS CSR ≥ 4).
Measures: Independent evaluators will administer a comprehensive assessment at baseline and post-treatment. The Anxiety Disorder Interview Schedule for Children for DSM-5 (ADIS-C-5)19 will measure the primary outcome of change in clinical severity of anxiety disorder symptoms across age groups. The Clinical Global Impression Scale (CGI) will assess overall symptom severity. The PARS and the MASC will provide secondary, dimensional measures of anxiety. In addition, we will measure treatment adherence and parent engagement as important secondary variables.
Fear Conditioning \& Extinction Paradigm: Subjects will participate in a laboratory test of extinction training prior to CBT in order to establish extinction learning as a potential predictive marker of treatment outcome. Subjects will be exposed to two shapes on a computer screen, one shape (conditioned stimulus (CS+) will be paired with an aversive sound (unconditioned stimulus) on 38% of the trials, whereas the other shape will never be paired with aversive sound (CS-)20. A day later, individuals will undergo extinction training in which the two conditioned stimuli will be repeatedly presented without the unconditioned stimulus. Extinction will be measured as the difference score of skin conductance response to the CS+ and CS-.
Exposure Therapy Intervention: investigators will offer participants an 8 session exposure therapy intervention. Session one will consist of psychoeducation and completion of an exposure hierarchy. Sessions 2-7 will consist of weekly gradual exposure sessions. Session 8 will include review, relapse prevention and referral to additional treatment if needed. Assessment measures will be given at the completion of each exposure session to assess individual differences in symptom change related to exposure therapy. All treatment sessions will be videotaped to ensure fidelity to treatment manual and modules.
Data analysis plan: Investigators will track the monthly number of participants screened and enrolled to determine feasibility of a larger trial, as well as session attendance, study attrition, treatment adherence and patient safety to assess acceptability of the selected measures and interventions. Though this pilot will not be adequately powered to detect statistical significance, the investigators will execute a preliminary test of the association between performance on the extinction learning task and treatment outcome, and the investigators will assess age group differences in extinction learning and treatment outcome to determine early proof of concept.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Trial | – | Behavioral: Open TrialN/A - Open Trial |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Youth with anxiety disorders ages 7-25
Key inclusion criteria (3 listed)
- Ages 7-25 years inclusively (i.e., must be at least 7 years) at the point of consent
- Primary DSM 5 diagnosis of SepAD, SocAD, OCD, specific phobia, or panic disorder on the ADIS-IV-C/P
- Anxiety severity of moderate or greater (CGI-S >3 and functional impairment (CGAS score 60)
Key exclusion criteria (14 listed)
- Estimated child Full Scale IQ < 80, as measured by the vocabulary and block design subtests of the WISC-III) (Gate B). If a potential subject has a verified IQ score in the three years prior to enrollment as measured by the WISC-III, IIIR, K-ABC, or Stanford-Binet no IQ assessment is required.
- Child meets criteria for current primary or co-primary major depressive disorder, conduct disorder or substance abuse
- Child meets criteria for Major Depressive Disorder at greater severity than anxiety disorder (Gate B)
- Subjects with the following lifetime psychiatric disorders will be excluded: bipolar disorder, PDD (Asperger's, autism), MDD with psychosis, schizophrenia, and schizoaffective disorder
- Current use of psychotropic medication or clinical indication for use of psychotropic medication (except for youth entering on a stable psychostimulant regimen for ADHD)
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 |
|---|---|---|
| Open TrialBehavioral Intervention | Behavioural | Open Trial |
Primary outcome
ADIS Evaluation
Time frame: 1 year
Anxiety Disorders Interview Schedule for DSM-5-Adult Version
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 17 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Shannon Bennett, PhD principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorder of Childhood, run by Weill Medical College of Cornell University.
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 3 inclusion and 14 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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
ADIS Evaluation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2019.