Anxiety DisordersNCT00769925
Assessing Different Methods of Anxiety Care in Pediatric Settings
A study testing Cognitive Behavior Therapy-Primary Care and Therapist-Assisted Bibliotherapy-Primary Care in people with Anxiety Disorders, run by University of California, San Diego at 1 site in United States.
Trial summary
This study will compare the effectiveness of delivering cognitive behavioral therapy for children with anxiety disorders through in-person contact versus through workbooks and telephone communication. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Cognitive Behavior Therapy-Primary Care and Therapist-Assisted Bibliotherapy-Primary Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 2012
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV criteria for one of the following disorders: separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, or obsessive-compulsive disorder
- Takes a medication and has maintained a stable dose for 3 months before baseline assessment
- Pediatric medical care is provided through one of the participating primary care clinics
- Parent and child are fluent in English
Who cannot join
- Presence of a life threatening condition or a medical illness that would make participation unsafe
- Diagnosed with bipolar disorder I, mental retardation, or autism or has psychotic symptoms
- Acutely suicidal or homicidal or exhibiting dangerous behavior
- Parents do not consent for diagnosis and progress to be shared with their child's primary care physician
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92123
About this study
Official title: Improving Care for Anxiety in Pediatric Settings
This study will compare the effectiveness of delivering cognitive behavioral therapy for children with anxiety disorders through in-person contact versus through workbooks and telephone communication.
Read the detailed description
Approximately 13% of adolescents aged 9 to 17 suffer from an anxiety disorder, which can cause disruptive fear, worry, or uneasiness that impairs their normal functioning. These anxiety disorders can include generalized anxiety disorder (GAD), phobias, panic disorder, and obsessive-compulsive disorder (OCD), and they often co-occur with a second anxiety disorder or another mental or behavioral disorder, like depression. Research on interventions such as cognitive behavioral therapy (CBT) indicates that these interventions are helpful to children who suffer from anxiety disorders, but are not always used. This study will examine the feasibility of implementing CBT for children between the ages of 8 and 13 in two different forms: through in-person contact at the pediatric primary care setting and through telephone-based contact.
Participants in this study will be randomly assigned to receive either cognitive behavioral therapy in primary care (CBT-PC) or therapist-assisted bibliotherapy in primary care (TAB-PC). In CBT-PC, participants will have therapy administered by a child anxiety specialist, and the parents of participants will learn how to support the new skills their children learn in therapy. In TAB-PC, parents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use CBT skills to manage their children's fears and worries. Participation in this study will last 3 to 4 months, with therapy visits occuring once a week at the beginning and tapering to once every other week at the end of treatment. At pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up, participants will undergo structured clinical interviews to assess their anxiety levels and the severity of their conditions.
- Conditions
- Anxiety Disorders
- Being tested
- Cognitive Behavior Therapy-Primary Care, Therapist-Assisted Bibliotherapy-Primary Care
- Keywords
- Generalized Anxiety, Social Phobia, Separation Anxiety, Phobia
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social, Anxiety, Separation, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy-Primary CareBehavioural
Also called Cognitive-Behavioral Therapy, CBT, Family CBT
Children will receive cognitive behavioral therapy from a child anxiety specialist at their doctor's office (the primary care clinic). The children will learn skills to cope with fear and anxiety, and parents will learn how to support their children in using these new skills.
Therapist-Assisted Bibliotherapy-Primary CareBehavioural
Also called Parent Training, Self-help, Therapist Assisted Bibliotherapy
Parents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use cognitive behavioral therapy skills to manage their children's fears and worries.
| Study group | Role | What they receive |
|---|---|---|
| Therapist Assisted Bibliotherapy-Primary Care (TAB-PC) | Experimental | Not described Receives: Behavioral: Therapist-Assisted Bibliotherapy-Primary Care |
| Cognitive Behavior Therapy-Primary Care (CBT-PC) | Experimental | Not described Receives: Behavioral: Cognitive Behavior Therapy-Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder
Measured: Measured at pre-treatment and post-treatment
Secondary outcomes (2)
Clinical Global Impression scale-Improvement Change
Measured: Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up
Screening for Anxiety Related Emotional Disorders (SCARED) parent and child self-report scales
Measured: Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2012
- Study completionFeb 2012
Why it stopped: PI is transitioning to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Denise A. Chavira, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769925
- Sponsor's protocol ID
- K01MH072952
- Other IDs
- K01MH072952, DSIR 84-CTS
- Status last verified
- Aug 2019
- First submitted
- 8 Oct 2008
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chavira DA, Drahota A, Garland AF, Roesch S, Garcia M, Stein MB. Feasibility of two modes of treatment delivery for child anxiety in primary care. Behav Res Ther. 2014 Sep;60:60-6. doi: 10.1016/j.brat.2014.06.010. Epub 2014 Jul 11.
PubMed 25075802
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Anxiety in Pediatric Settings
- ClinicalTrials.gov ID
- NCT00769925
- Acronym / sponsor ID
- K01MH072952
- Conditions
- Anxiety Disorders
- Keywords
- Generalized Anxiety, Social Phobia, Separation Anxiety, Phobia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is transitioning to another institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2008 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 9 Oct 2008 (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 study will compare the effectiveness of delivering cognitive behavioral therapy for children with anxiety disorders through in-person contact versus through workbooks and telephone communication.
Detailed description
Approximately 13% of adolescents aged 9 to 17 suffer from an anxiety disorder, which can cause disruptive fear, worry, or uneasiness that impairs their normal functioning. These anxiety disorders can include generalized anxiety disorder (GAD), phobias, panic disorder, and obsessive-compulsive disorder (OCD), and they often co-occur with a second anxiety disorder or another mental or behavioral disorder, like depression. Research on interventions such as cognitive behavioral therapy (CBT) indicates that these interventions are helpful to children who suffer from anxiety disorders, but are not always used. This study will examine the feasibility of implementing CBT for children between the ages of 8 and 13 in two different forms: through in-person contact at the pediatric primary care setting and through telephone-based contact.
Participants in this study will be randomly assigned to receive either cognitive behavioral therapy in primary care (CBT-PC) or therapist-assisted bibliotherapy in primary care (TAB-PC). In CBT-PC, participants will have therapy administered by a child anxiety specialist, and the parents of participants will learn how to support the new skills their children learn in therapy. In TAB-PC, parents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use CBT skills to manage their children's fears and worries. Participation in this study will last 3 to 4 months, with therapy visits occuring once a week at the beginning and tapering to once every other week at the end of treatment. At pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up, participants will undergo structured clinical interviews to assess their anxiety levels and the severity of their conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapist Assisted Bibliotherapy-Primary Care (TAB-PC) | Experimental | Behavioral: Therapist-Assisted Bibliotherapy-Primary Care |
| Cognitive Behavior Therapy-Primary Care (CBT-PC) | Experimental | Behavioral: Cognitive Behavior Therapy-Primary Care |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Meets DSM-IV criteria for one of the following disorders: separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, or obsessive-compulsive disorder
- Takes a medication and has maintained a stable dose for 3 months before baseline assessment
- Pediatric medical care is provided through one of the participating primary care clinics
- Parent and child are fluent in English
Key exclusion criteria (4 listed)
- Presence of a life threatening condition or a medical illness that would make participation unsafe
- Diagnosed with bipolar disorder I, mental retardation, or autism or has psychotic symptoms
- Acutely suicidal or homicidal or exhibiting dangerous behavior
- Parents do not consent for diagnosis and progress to be shared with their child's primary care physician
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 Behavior Therapy-Primary CareAlso: Cognitive-Behavioral Therapy, CBT, Family CBTChildren will receive cognitive behavioral therapy from a child anxiety specialist at their doctor's office (the primary care clinic). The children will learn skills to cope with fear and anxiety, and parents will learn how to support their children in using these new skills. | Behavioural | Cognitive Behavior Therapy-Primary Care (CBT-PC) |
| Therapist-Assisted Bibliotherapy-Primary CareAlso: Parent Training, Self-help, Therapist Assisted BibliotherapyParents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use cognitive behavioral therapy skills to manage their children's fears and worries. | Behavioural | Therapist Assisted Bibliotherapy-Primary Care (TAB-PC) |
Primary outcome
Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder
Time frame: Measured at pre-treatment and post-treatment
2 secondary outcomes
Clinical Global Impression scale-Improvement Change
Time frame: Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up
Screening for Anxiety Related Emotional Disorders (SCARED) parent and child self-report scales
Time frame: Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Derived from this study: PubMed 25075802Chavira DA, Drahota A, Garland AF, Roesch S, Garcia M, Stein MB. Feasibility of two modes of treatment delivery for child anxiety in primary care. Behav Res Ther. 2014 Sep;60:60-6. doi: 10.1016/j.brat.2014.06.010. Epub 2014 Jul 11.
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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.
Denise A. Chavira, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy-Primary Care and Therapist-Assisted Bibliotherapy-Primary Care in people with Anxiety Disorders, run by University of California, San Diego 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 4 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: withdrawn, as of the sponsor's last update on 15 Aug 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder (time frame: Measured at pre-treatment and post-treatment). 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 NCT00769925, which also lists 1 linked publication.
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 15 Aug 2019.