Anxiety DisordersNCT00557648
Evaluating the Effectiveness of Early Cognitive Behavioral Therapy With or Without Parental Involvement in Treating Anxious Children
A study testing Group CBT for children and Group CBT for children plus parent training in people with Anxiety Disorders, run by University of Minnesota at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of school-based cognitive behavioral therapy with or without parental involvement in treating anxious children. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Group CBT for children and Group CBT for children plus parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jul 2007
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Total Anxiety T-score of greater than 57 on Multidimensional Anxiety Scale for Children and/or teacher nomination as one of the most anxious children in the classroom
- Meets DSM-IV criteria for separation anxiety disorder, generalized anxiety disorder, and/or social phobia, or features (one or more, but not all criteria) of one of these disorders with an associated composite CSR of 2 to 6 on ADIS
- Both parent and child speak English fluently
Who cannot join
- Current diagnosis of the following on ADIS: obsessive-compulsive disorder, posttraumatic stress disorder, attention-deficit hyperactivity disorder, conduct disorder, schizophrenia, pervasive developmental disorder, major depression, or substance abuse
- Current suicidal or homicidal intent or plan
- Diagnosis of mental retardation (IQ less than 71) on the Kaufman Brief Intelligence Test (KBIT)
- Currently receiving psychotropic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Divisions of Child and Adolescent Psychiatry, University of Minnesota Medical School
Minneapolis, Minnesota, 55454
About this study
Official title: Early Interventions for Anxious Children
This study will evaluate the effectiveness of school-based cognitive behavioral therapy with or without parental involvement in treating anxious children.
Read the detailed description
Anxiety disorders are among the most common disorders in children. Although anxiety is a normal part of growing up, the worrying experienced by children with anxiety disorders can persist to the point that day-to-day functioning becomes difficult. Physical symptoms of anxiety disorders include a constant sense of worry or stress, headache, nausea, sweating, shaking, and inability to concentrate. Early identification of anxiety disorders is important to prevent progression of the disorder into a chronic issue. Cognitive behavioral therapy (CBT), which focuses on behavioral and thinking modifications, has been shown to be the most effective treatment for anxiety disorders. This study will evaluate the effectiveness of school-based CBT with or without parental involvement in treating anxious children who meet DSM-IV criteria or have features of separation anxiety disorder, generalized anxiety disorder, and social phobia.
Participants in this single blind study will be randomly assigned by school to one of three treatment groups: CBT for children only, CBT for children plus parent training, and no-treatment control. Each child and parent participant will first undergo an interview, lasting between 1 and 1.5 hours, about the child's symptoms. Additionally, parents will complete rating scales about their children's symptoms and their own symptoms. The participants receiving CBT will then attend 9 weekly group sessions held in the school buildings after school. In the parental involvement group, parents will attend 9 weekly group parent-training sessions held at the same time as the children's CBT group sessions. During the children's CBT sessions, participants will learn techniques to identify feelings of worry, relax, modify negative thoughts, break down difficult situations into smaller achievable steps, reward themselves for trying hard, and maintain treatment gains. For the parent training group, early sessions will focus on normalizing anxiety during childhood, learning about anxiety, and identifying when their children are feeling anxious. The middle sessions will teach parents the same anxiety management skills being taught to their children and ways to help their children to apply the steps at home. The latter sessions will instruct parents on ways to encourage their children's behaviors in anxiety-provoking situations. After completing the 9-week program, participants will attend 2 follow-up booster sessions at Months 1 and 3 post-treatment. Follow-up assessments will occur at Months 3 and 6 and at Years 1, 2, 3, and 4 post-treatment. The assessments will include repeat interviews and rating scales. At the end of the 6-month follow-up assessment, participants in the no-treatment control group will have the opportunity to participate in the CBT group treatments.
- Conditions
- Anxiety Disorders
- Being tested
- Group CBT for children, Group CBT for children plus parent training
- Keywords
- Anxiety, Children, Cognitive-Behavioral Therapy, School-Based Interventions
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CBT for childrenBehavioural
CBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours.
Group CBT for children plus parent trainingBehavioural
CBT involving children and parents consists of 9 weekly group CBT sessions for the children and 9 weekly concurrent group parent training sessions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CBT for children only Receives: Behavioral: Group CBT for children |
| 2 | Experimental | CBT for children with parental involvement Receives: Behavioral: Group CBT for children plus parent training |
| 3 | No intervention | No intervention control group: families free to seek treatment on their own |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis
Measured: Measured at Month 6 and Years 1, 2, 3, and 4 post-treatment
Secondary outcomes (1)
Multidimensional Anxiety Scale for Children, Scale for Child Anxiety Related Emotional Disorders, Clinical Global Impressions-Improvement Scale, Family Adaptability and Cohesion Evaluation Scale II, and Behavior Assessment System for Children
Measured: Measured at Months 3 and 6 and Years 1, 2, 3, and 4 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startOct 2002
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 MinnesotaThe 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gail A. Bernstein, MD, Principal investigator, Division of Child and Adolescent Psychiatry, University of Minnesota Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557648
- Sponsor's protocol ID
- FWA00000312-4
- Other IDs
- R21MH065369
- Status last verified
- Oct 2019
- First submitted
- 13 Nov 2007
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bernstein GA, Layne AE, Egan EA, Tennison DM. School-based interventions for anxious children. J Am Acad Child Adolesc Psychiatry. 2005 Nov;44(11):1118-27. doi: 10.1097/01.chi.0000177323.40005.a1.
PubMed 16239860Bernstein GA, Layne AE, Egan EA, Nelson LP. Maternal phobic anxiety and child anxiety. J Anxiety Disord. 2005;19(6):658-72. doi: 10.1016/j.janxdis.2004.09.001.
PubMed 15927779Layne AE, Bernstein GA, March JS. Teacher awareness of anxiety symptoms in children. Child Psychiatry Hum Dev. 2006 Summer;36(4):383-92. doi: 10.1007/s10578-006-0009-6.
PubMed 16736381Victor AM, Bernat DH, Bernstein GA, Layne AE. Effects of parent and family characteristics on treatment outcome of anxious children. J Anxiety Disord. 2007;21(6):835-48. doi: 10.1016/j.janxdis.2006.11.005. Epub 2006 Dec 11.
PubMed 17161582Bernstein GA, Bernat DH, Davis AA, Layne AE. Symptom presentation and classroom functioning in a nonclinical sample of children with social phobia. Depress Anxiety. 2008;25(9):752-60. doi: 10.1002/da.20315.
PubMed 17557318Bernstein GA, Bernat DH, Victor AM, Layne AE. School-based interventions for anxious children: 3-, 6-, and 12-month follow-ups. J Am Acad Child Adolesc Psychiatry. 2008 Sep;47(9):1039-47. doi: 10.1097/CHI.ob013e31817eecco.
PubMed 18665000Layne AE, Bernat DH, Victor AM, Bernstein GA. Generalized anxiety disorder in a nonclinical sample of children: symptom presentation and predictors of impairment. J Anxiety Disord. 2009 Mar;23(2):283-9. doi: 10.1016/j.janxdis.2008.08.003. Epub 2008 Aug 12.
PubMed 18815006
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Interventions for Anxious Children
- ClinicalTrials.gov ID
- NCT00557648
- Acronym / sponsor ID
- FWA00000312-4
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, Children, Cognitive-Behavioral Therapy, School-Based Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2002
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 14 Nov 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.
This study will evaluate the effectiveness of school-based cognitive behavioral therapy with or without parental involvement in treating anxious children.
Detailed description
Anxiety disorders are among the most common disorders in children. Although anxiety is a normal part of growing up, the worrying experienced by children with anxiety disorders can persist to the point that day-to-day functioning becomes difficult. Physical symptoms of anxiety disorders include a constant sense of worry or stress, headache, nausea, sweating, shaking, and inability to concentrate. Early identification of anxiety disorders is important to prevent progression of the disorder into a chronic issue. Cognitive behavioral therapy (CBT), which focuses on behavioral and thinking modifications, has been shown to be the most effective treatment for anxiety disorders. This study will evaluate the effectiveness of school-based CBT with or without parental involvement in treating anxious children who meet DSM-IV criteria or have features of separation anxiety disorder, generalized anxiety disorder, and social phobia.
Participants in this single blind study will be randomly assigned by school to one of three treatment groups: CBT for children only, CBT for children plus parent training, and no-treatment control. Each child and parent participant will first undergo an interview, lasting between 1 and 1.5 hours, about the child's symptoms. Additionally, parents will complete rating scales about their children's symptoms and their own symptoms. The participants receiving CBT will then attend 9 weekly group sessions held in the school buildings after school. In the parental involvement group, parents will attend 9 weekly group parent-training sessions held at the same time as the children's CBT group sessions. During the children's CBT sessions, participants will learn techniques to identify feelings of worry, relax, modify negative thoughts, break down difficult situations into smaller achievable steps, reward themselves for trying hard, and maintain treatment gains. For the parent training group, early sessions will focus on normalizing anxiety during childhood, learning about anxiety, and identifying when their children are feeling anxious. The middle sessions will teach parents the same anxiety management skills being taught to their children and ways to help their children to apply the steps at home. The latter sessions will instruct parents on ways to encourage their children's behaviors in anxiety-provoking situations. After completing the 9-week program, participants will attend 2 follow-up booster sessions at Months 1 and 3 post-treatment. Follow-up assessments will occur at Months 3 and 6 and at Years 1, 2, 3, and 4 post-treatment. The assessments will include repeat interviews and rating scales. At the end of the 6-month follow-up assessment, participants in the no-treatment control group will have the opportunity to participate in the CBT group treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Group CBT for childrenCBT for children only |
| 2 | Experimental | Behavioral: Group CBT for children plus parent trainingCBT for children with parental involvement |
| 3 | No intervention | –No intervention control group: families free to seek treatment on their own |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Total Anxiety T-score of greater than 57 on Multidimensional Anxiety Scale for Children and/or teacher nomination as one of the most anxious children in the classroom
- Meets DSM-IV criteria for separation anxiety disorder, generalized anxiety disorder, and/or social phobia, or features (one or more, but not all criteria) of one of these disorders with an associated composite CSR of 2 to 6 on ADIS
- Both parent and child speak English fluently
Key exclusion criteria (4 listed)
- Current diagnosis of the following on ADIS: obsessive-compulsive disorder, posttraumatic stress disorder, attention-deficit hyperactivity disorder, conduct disorder, schizophrenia, pervasive developmental disorder, major depression, or substance abuse
- Current suicidal or homicidal intent or plan
- Diagnosis of mental retardation (IQ less than 71) on the Kaufman Brief Intelligence Test (KBIT)
- Currently receiving psychotropic medication
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 |
|---|---|---|
| Group CBT for childrenCBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours. | Behavioural | 1 |
| Group CBT for children plus parent trainingCBT involving children and parents consists of 9 weekly group CBT sessions for the children and 9 weekly concurrent group parent training sessions. | Behavioural | 2 |
Primary outcome
Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis
Time frame: Measured at Month 6 and Years 1, 2, 3, and 4 post-treatment
1 secondary outcome
Multidimensional Anxiety Scale for Children, Scale for Child Anxiety Related Emotional Disorders, Clinical Global Impressions-Improvement Scale, Family Adaptability and Cohesion Evaluation Scale II, and Behavior Assessment System for Children
Time frame: Measured at Months 3 and 6 and Years 1, 2, 3, and 4 post-treatment
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 1 Nov 2019.
- Results publication: PubMed 16239860Bernstein GA, Layne AE, Egan EA, Tennison DM. School-based interventions for anxious children. J Am Acad Child Adolesc Psychiatry. 2005 Nov;44(11):1118-27. doi: 10.1097/01.chi.0000177323.40005.a1.
- Results publication: PubMed 15927779Bernstein GA, Layne AE, Egan EA, Nelson LP. Maternal phobic anxiety and child anxiety. J Anxiety Disord. 2005;19(6):658-72. doi: 10.1016/j.janxdis.2004.09.001.
- Results publication: PubMed 16736381Layne AE, Bernstein GA, March JS. Teacher awareness of anxiety symptoms in children. Child Psychiatry Hum Dev. 2006 Summer;36(4):383-92. doi: 10.1007/s10578-006-0009-6.
- Results publication: PubMed 17161582Victor AM, Bernat DH, Bernstein GA, Layne AE. Effects of parent and family characteristics on treatment outcome of anxious children. J Anxiety Disord. 2007;21(6):835-48. doi: 10.1016/j.janxdis.2006.11.005. Epub 2006 Dec 11.
- Results publication: PubMed 17557318Bernstein GA, Bernat DH, Davis AA, Layne AE. Symptom presentation and classroom functioning in a nonclinical sample of children with social phobia. Depress Anxiety. 2008;25(9):752-60. doi: 10.1002/da.20315.
- Results publication: PubMed 18665000Bernstein GA, Bernat DH, Victor AM, Layne AE. School-based interventions for anxious children: 3-, 6-, and 12-month follow-ups. J Am Acad Child Adolesc Psychiatry. 2008 Sep;47(9):1039-47. doi: 10.1097/CHI.ob013e31817eecco.
- Results publication: PubMed 18815006Layne AE, Bernat DH, Victor AM, Bernstein GA. Generalized anxiety disorder in a nonclinical sample of children: symptom presentation and predictors of impairment. J Anxiety Disord. 2009 Mar;23(2):283-9. doi: 10.1016/j.janxdis.2008.08.003. Epub 2008 Aug 12.
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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.
Gail A. Bernstein, MD principal investigator
Division of Child and Adolescent Psychiatry, University of Minnesota Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group CBT for children and Group CBT for children plus parent training in people with Anxiety Disorders, run by University of Minnesota 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 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 1 Nov 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 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?
Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis (time frame: Measured at Month 6 and Years 1, 2, 3, and 4 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 NCT00557648, which also lists 7 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 1 Nov 2019.