Separation Anxiety DisorderPhase 2KATESNCT00569829
Modular Cognitive Behavioral Therapy for the Treatment of Child Anxiety Disorders in Elementary School Settings
A Phase 2 study testing cognitive behavioral therapy in people with Separation Anxiety Disorder and Generalized Anxiety Disorder, run by University of California, Los Angeles.
Trial summary
Although cognitive behavioral therapy (CBT) has been found to be efficacious in the treatment of child anxiety disorders, little progress has been made in the dissemination of such treatments to real-world practice settings. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jun 2009
- Phase
- Phase 2
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child meets DSM-IV criteria for separation anxiety disorder (SAD), social phobia, or generalized anxiety disorder (GAD) based on a diagnostic interview
- The child is not taking any psychiatric medication at the initial assessment, or is taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment)
- If medication is being used, children will maintain that dose throughout the study
Who cannot join
- The child is currently in psychotherapy
- The family is currently in family therapy or a parenting class
- The child begins taking psychiatric medication or increases his/her dose of medication during the intervention
- For any reason the child or parents appear unable to participate in the intervention program.
About this study
Official title: A Randomized, Controlled Trial of Modular CBT for Child Anxiety Disorders in Elementary School Settings
Although cognitive behavioral therapy (CBT) has been found to be efficacious in the treatment of child anxiety disorders, little progress has been made in the dissemination of such treatments to real-world practice settings. Clinical trials conducted in practice settings can demonstrate the degree to which evidence-based treatments are appropriate for larger scale dissemination. This study evaluates CBT as a treatment for child anxiety disorders in the elementary school clinic setting. A randomized, controlled trial design has been employed, comparing immediate treatment and a three-month waitlist. The trial is being conducted in several Los Angeles area elementary schools and is only available to children in these particular schools. To ensure that the CBT intervention is flexible and capable of matching the characteristics of various school settings, clinicians, and referred children, a modular treatment approach is employed. The study design includes elements to ensure high quality data, such as the use of independent evaluators and tests of treatment fidelity. Children, ages 5 to 12 years, are referred by teachers and staff or are identified as having high anxiety in concurrent studies. All participating children have DSM-IV diagnoses of separation anxiety disorder, generalized anxiety disorder, or social phobia, according to a semi-structured diagnostic interview. Therapy and clinical supervision is provided by the research team. It is hypothesized that children receiving immediate treatment will have significantly lower anxiety scores than children assigned to the waitlist at the posttreatment/postwaitlist assessment. If results are favorable, further exploration of dissemination of CBT into school clinic settings may be indicated.
- Being tested
- cognitive behavioral therapy
- Keywords
- cognitive behavioral therapy, anxiety disorders, school-based intervention, randomized, controlled trial
- Medical subject headings
- Anxiety, Separation, Generalized Anxiety Disorder, Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cognitive behavioral therapy Receives: Behavioral: cognitive behavioral therapy |
| 2 | No intervention | Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician's Global Impressions-Improvement (CGI) scale
Measured: Posttreatment / postwaitlist
Secondary outcomes (1)
Anxiety Disorders Interview Schedule IV: Child and Parent Version
Measured: Posttreatment / postwaitlist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startJan 2004
- Primary completionJun 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Separation Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey J. Wood, University of California, Los Angeles
- Investigators
- Jeffrey J Wood, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569829
- Sponsor's protocol ID
- G04-06-117-04
- Acronym
- KATES
- Status last verified
- Mar 2012
- First submitted
- 5 Dec 2007
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Modular CBT for Child Anxiety Disorders in Elementary School Settings
- ClinicalTrials.gov ID
- NCT00569829
- Acronym / sponsor ID
- KATES / G04-06-117-04
- Keywords
- cognitive behavioral therapy, anxiety disorders, school-based intervention, randomized, controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Dec 2007 (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.
Although cognitive behavioral therapy (CBT) has been found to be efficacious in the treatment of child anxiety disorders, little progress has been made in the dissemination of such treatments to real-world practice settings. Clinical trials conducted in practice settings can demonstrate the degree to which evidence-based treatments are appropriate for larger scale dissemination. This study evaluates CBT as a treatment for child anxiety disorders in the elementary school clinic setting. A randomized, controlled trial design has been employed, comparing immediate treatment and a three-month waitlist. The trial is being conducted in several Los Angeles area elementary schools and is only available to children in these particular schools. To ensure that the CBT intervention is flexible and capable of matching the characteristics of various school settings, clinicians, and referred children, a modular treatment approach is employed. The study design includes elements to ensure high quality data, such as the use of independent evaluators and tests of treatment fidelity. Children, ages 5 to 12 years, are referred by teachers and staff or are identified as having high anxiety in concurrent studies. All participating children have DSM-IV diagnoses of separation anxiety disorder, generalized anxiety disorder, or social phobia, according to a semi-structured diagnostic interview. Therapy and clinical supervision is provided by the research team. It is hypothesized that children receiving immediate treatment will have significantly lower anxiety scores than children assigned to the waitlist at the posttreatment/postwaitlist assessment. If results are favorable, further exploration of dissemination of CBT into school clinic settings may be indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: cognitive behavioral therapyCognitive behavioral therapy |
| 2 | No intervention | –Waitlist |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The child meets DSM-IV criteria for separation anxiety disorder (SAD), social phobia, or generalized anxiety disorder (GAD) based on a diagnostic interview
- The child is not taking any psychiatric medication at the initial assessment, or is taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment)
- If medication is being used, children will maintain that dose throughout the study
Key exclusion criteria (4 listed)
- The child is currently in psychotherapy
- The family is currently in family therapy or a parenting class
- The child begins taking psychiatric medication or increases his/her dose of medication during the intervention
- For any reason the child or parents appear unable to participate in the intervention program.
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 |
|---|---|---|
| cognitive behavioral therapy1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes | Behavioural | 1 |
Primary outcome
Clinician's Global Impressions-Improvement (CGI) scale
Time frame: Posttreatment / postwaitlist
1 secondary outcome
Anxiety Disorders Interview Schedule IV: Child and Parent Version
Time frame: Posttreatment / postwaitlist
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 30 Mar 2012.
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Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation
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Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.
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Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence
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Partners in Caring for Anxious Youth
Anxiety, Separation, Anxiety, Generalized
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.
Jeffrey J Wood, PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cognitive behavioral therapy in people with Separation Anxiety Disorder and Generalized Anxiety Disorder, run by University of California, Los Angeles.
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 4 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 30 Mar 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinician's Global Impressions-Improvement (CGI) scale (time frame: Posttreatment / postwaitlist). 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 30 Mar 2012.