AnxietyYADSNCT01005836
Community Clinic Test of Youth Anxiety Treatment
A study testing Cognitive behavioral therapy for youth anxiety, Usual clinic care and Cognitive behavioral treatment for youth depression in people with Anxiety and Depression, run by Harvard University.
Trial summary
Structured, manualized treatments have been developed for numerous mental health problems and disorders among children and adolescents, and a number of these have shown strong beneficial effects in clinical trials. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Cognitive behavioral therapy for youth anxiety, Usual clinic care and Cognitive behavioral treatment for youth depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Feb 1998to May 2005
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary DSM-IV anxiety or depressive disorder
Who cannot join
- Pervasive developmental disorder
- Psychotic disorder
- Mental retardation
About this study
Official title: Community Clinic Test of Youth Anxiety and Depression Study
Structured, manualized treatments have been developed for numerous mental health problems and disorders among children and adolescents, and a number of these have shown strong beneficial effects in clinical trials. Such findings have led to proposals that the empirically supported treatments be used to improve outcomes of conventional clinic treatment, which some research suggests may not be very effective. But can these lab-tested treatments actually work in service-oriented clinics with referred youth? Available evidence cannot tell us, because the therapists, conditions, and clientele in the laboratory efficacy tests tend to differ so markedly from those of clinical practice. To assess the clinical potential of efficacy-tested treatments, we need effectiveness research that tests these treatments in the crucible of clinical practice. To help begin this process, the proposed research focuses on a specific treatment program for a specific cluster of disorders: Kendall's (1994) cognitive-behavioral "Coping Cat" program for child and adolescent anxiety disorders. The program has shown unusually positive effects across a series of clinical trials in the U.S. and Australia, but it has never been tested in real-world clinical conditions. The proposed study will test the effectiveness of the treatment with clinic-referred youth, treated in community clinics, with the treatment carried out by clinic staff therapists. Some 128 youth, aged 9-14, referred for anxiety and diagnosed with anxiety disorders, will be randomly assigned to receive either the usual treatment in the clinic, or the Kendall program, carried out by clinic staff who have been trained to proficiency. Therapists for the two treatment conditions will also be chosen randomly, from a pool of volunteers. Outcome assessment at immediate post-treatment, 1-year, and 2-year follow-ups, will test effects across many outcomes. It is hypothesized that outcomes for youths treated using the cognitive-behavioral treatment will be superior to those treated using usual care.
- Conditions
- Anxiety, Depression
- Being tested
- Cognitive behavioral therapy for youth anxiety, Usual clinic care, Cognitive behavioral treatment for youth depression
- Keywords
- Cognitive behavioral therapy, Anxiety treatment, Depression treatment, Child treatment, Usual care
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for youth anxietyBehavioural
Also called Coping Cat
Usual clinic careOther
Cognitive behavioral treatment for youth depressionBehavioural
Also called PASCET
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral therapy: Anxiety | Experimental | CBT for child anxiety. Coping Cat. Receives: Behavioral: Cognitive behavioral therapy for youth anxiety |
| Usual care: Anxiety | Other | Usual clinic care Receives: Other: Usual clinic care |
| Cognitive behavioral therapy: depression | Experimental | CBT for youth depression. The Primary and Secondary Control Enhancement Training protocol. Receives: Behavioral: Cognitive behavioral treatment for youth depression |
| Usual care: Depression | Other | Usual clinic care for depression Receives: Other: Usual clinic care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startFeb 1998
- Primary completionMay 2005
- Study completionMay 2005
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 AnxietyStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Weisz, Harvard University
- Investigators
- John R Weisz, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005836
- Sponsor's protocol ID
- R01MH057347
- Acronym
- YADS
- Status last verified
- Mar 2017
- First submitted
- 30 Oct 2009
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weisz JR, Southam-Gerow MA, Gordis EB, Connor-Smith JK, Chu BC, Langer DA, McLeod BD, Jensen-Doss A, Updegraff A, Weiss B. Cognitive-behavioral therapy versus usual clinical care for youth depression: an initial test of transportability to community clinics and clinicians. J Consult Clin Psychol. 2009 Jun;77(3):383-96. doi: 10.1037/a0013877.
PubMed 19485581Southam-Gerow MA, Weisz JR, Chu BC, McLeod BD, Gordis EB, Connor-Smith JK. Does cognitive behavioral therapy for youth anxiety outperform usual care in community clinics? An initial effectiveness test. J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):1043-52. doi: 10.1016/j.jaac.2010.06.009. Epub 2010 Jul 31.
PubMed 20855049
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Clinic Test of Youth Anxiety and Depression Study
- ClinicalTrials.gov ID
- NCT01005836
- Acronym / sponsor ID
- YADS / R01MH057347
- Conditions
- Anxiety, Depression
- Keywords
- Cognitive behavioral therapy, Anxiety treatment, Depression treatment, Child treatment, Usual care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- Feb 1998
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 2 Nov 2009 (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.
Structured, manualized treatments have been developed for numerous mental health problems and disorders among children and adolescents, and a number of these have shown strong beneficial effects in clinical trials. Such findings have led to proposals that the empirically supported treatments be used to improve outcomes of conventional clinic treatment, which some research suggests may not be very effective. But can these lab-tested treatments actually work in service-oriented clinics with referred youth? Available evidence cannot tell us, because the therapists, conditions, and clientele in the laboratory efficacy tests tend to differ so markedly from those of clinical practice. To assess the clinical potential of efficacy-tested treatments, we need effectiveness research that tests these treatments in the crucible of clinical practice. To help begin this process, the proposed research focuses on a specific treatment program for a specific cluster of disorders: Kendall's (1994) cognitive-behavioral "Coping Cat" program for child and adolescent anxiety disorders. The program has shown unusually positive effects across a series of clinical trials in the U.S. and Australia, but it has never been tested in real-world clinical conditions. The proposed study will test the effectiveness of the treatment with clinic-referred youth, treated in community clinics, with the treatment carried out by clinic staff therapists. Some 128 youth, aged 9-14, referred for anxiety and diagnosed with anxiety disorders, will be randomly assigned to receive either the usual treatment in the clinic, or the Kendall program, carried out by clinic staff who have been trained to proficiency. Therapists for the two treatment conditions will also be chosen randomly, from a pool of volunteers. Outcome assessment at immediate post-treatment, 1-year, and 2-year follow-ups, will test effects across many outcomes. It is hypothesized that outcomes for youths treated using the cognitive-behavioral treatment will be superior to those treated using usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy: Anxiety | Experimental | Behavioral: Cognitive behavioral therapy for youth anxietyCBT for child anxiety. Coping Cat. |
| Usual care: Anxiety | Other | Other: Usual clinic careUsual clinic care |
| Cognitive behavioral therapy: depression | Experimental | Behavioral: Cognitive behavioral treatment for youth depressionCBT for youth depression. The Primary and Secondary Control Enhancement Training protocol. |
| Usual care: Depression | Other | Other: Usual clinic careUsual clinic care for depression |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary DSM-IV anxiety or depressive disorder
Key exclusion criteria (3 listed)
- Pervasive developmental disorder
- Psychotic disorder
- Mental retardation
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 therapy for youth anxietyAlso: Coping Cat | Behavioural | Cognitive-behavioral therapy: Anxiety |
| Usual clinic care | Other | Usual care: Anxiety, Usual care: Depression |
| Cognitive behavioral treatment for youth depressionAlso: PASCET | Behavioural | Cognitive behavioral therapy: depression |
Primary outcome
Not reported in the source record.
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 2017.
- Results publication: PubMed 19485581Weisz JR, Southam-Gerow MA, Gordis EB, Connor-Smith JK, Chu BC, Langer DA, McLeod BD, Jensen-Doss A, Updegraff A, Weiss B. Cognitive-behavioral therapy versus usual clinical care for youth depression: an initial test of transportability to community clinics and clinicians. J Consult Clin Psychol. 2009 Jun;77(3):383-96. doi: 10.1037/a0013877.
- Derived from this study: PubMed 20855049Southam-Gerow MA, Weisz JR, Chu BC, McLeod BD, Gordis EB, Connor-Smith JK. Does cognitive behavioral therapy for youth anxiety outperform usual care in community clinics? An initial effectiveness test. J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):1043-52. doi: 10.1016/j.jaac.2010.06.009. Epub 2010 Jul 31.
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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.
John R Weisz, PhD principal investigator
Harvard University
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for youth anxiety, Usual clinic care and Cognitive behavioral treatment for youth depression in people with Anxiety and Depression, run by Harvard 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 1 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 30 Mar 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005836, 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 30 Mar 2017.