AnxietyPhase 2/3NCT00081406
Individual and Family Therapy for Children With Anxiety Disorders
A Phase 2/3 study testing Individual Child CBT, Family CBT and Education/Support/Attention in people with Anxiety, run by Temple University at 1 site in United States.
Trial summary
The purpose of this study is to compare three treatments to determine which is most effective in reducing anxiety in children. Read more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Individual Child CBT, Family CBT and Education/Support/Attention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to not given
- Phase
- Phase 2/3
- 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 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with DSM-IV criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder
Who cannot join
- IQ less than 80
- Current use of anti-anxiety or antidepressant medications
- Psychotic symptoms
- Child and/or parent is non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Child and Adolescent Anxiety Disorders Clinic
Philadelphia, Pennsylvania, 19122
About this study
Official title: Child and Family Therapy for Anxiety-Disordered Youth
The purpose of this study is to compare three treatments to determine which is most effective in reducing anxiety in children.
Read the detailed description
Children and their parents will complete a comprehensive diagnostic assessment to determine eligibility. The assessment will include an individual diagnostic interview with the child, interviews with the parents, and written observations of the child from family members and teachers. Participants will then be randomly assigned to receive individual cognitive behavioral therapy (ICBT), family CBT (FCBT), or education/support/attention (ESA) for 5 months. Children in the ICBT group will meet individually with a therapist. In the FCBT and ESA treatment groups, children and their parents will meet weekly with a therapist.
At the end of treatment and 1 year following treatment completion, families will complete another assessment to determine the effectiveness of each treatment at reducing short- and long-term anxiety symptoms in their children.
- Conditions
- Anxiety
- Being tested
- Individual Child CBT, Family CBT, Education/Support/Attention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Child CBTBehavioural
Family CBTBehavioural
Education/Support/AttentionBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2004 (estimated)
- Study startJul 2000
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081406
- Sponsor's protocol ID
- R01MH059087
- Other IDs
- R01MH059087, DSIR CT-S
- Status last verified
- Mar 2005
- First submitted
- 9 Apr 2004
- Last updated
- 6 Mar 2014
- Results posted
- No
Publications
Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10. doi: 10.1037//0022-006x.62.1.100.
PubMed 8034812Kendall PC, Flannery-Schroeder E, Panichelli-Mindel SM, Southam-Gerow M, Henin A, Warman M. Therapy for youths with anxiety disorders: a second randomized clinical trial. J Consult Clin Psychol. 1997 Jun;65(3):366-80. doi: 10.1037//0022-006x.65.3.366.
PubMed 9170760
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child and Family Therapy for Anxiety-Disordered Youth
- ClinicalTrials.gov ID
- NCT00081406
- Acronym / sponsor ID
- R01MH059087
- Conditions
- Anxiety
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2000
- First posted
- 12 Apr 2004 (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 purpose of this study is to compare three treatments to determine which is most effective in reducing anxiety in children.
Detailed description
Children and their parents will complete a comprehensive diagnostic assessment to determine eligibility. The assessment will include an individual diagnostic interview with the child, interviews with the parents, and written observations of the child from family members and teachers. Participants will then be randomly assigned to receive individual cognitive behavioral therapy (ICBT), family CBT (FCBT), or education/support/attention (ESA) for 5 months. Children in the ICBT group will meet individually with a therapist. In the FCBT and ESA treatment groups, children and their parents will meet weekly with a therapist.
At the end of treatment and 1 year following treatment completion, families will complete another assessment to determine the effectiveness of each treatment at reducing short- and long-term anxiety symptoms in their children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child with DSM-IV criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder
Key exclusion criteria (4 listed)
- IQ less than 80
- Current use of anti-anxiety or antidepressant medications
- Psychotic symptoms
- Child and/or parent is non-English speaking
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 |
|---|---|---|
| Individual Child CBT | Behavioural | – |
| Family CBT | Behavioural | – |
| Education/Support/Attention | Behavioural | – |
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 6 Mar 2014.
- Background: PubMed 8034812Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10. doi: 10.1037//0022-006x.62.1.100.
- Background: PubMed 9170760Kendall PC, Flannery-Schroeder E, Panichelli-Mindel SM, Southam-Gerow M, Henin A, Warman M. Therapy for youths with anxiety disorders: a second randomized clinical trial. J Consult Clin Psychol. 1997 Jun;65(3):366-80. doi: 10.1037//0022-006x.65.3.366.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Individual Child CBT, Family CBT and Education/Support/Attention in people with Anxiety, run by Temple 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 1 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 6 Mar 2014. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00081406, 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 6 Mar 2014.