- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160444
Investigating the Effects of Parent Component to Cognitive Behavior Therapy (CBT) for Youth With Anxiety Disorders
May 10, 2016 updated by: Kevin D. Stark, University of Texas at Austin
Investigating the Effects of an Added Parent Component to Cognitive Behavior Therapy for Youth With Anxiety Disorders
Investigation is designed to determine whether the gold standard for treating anxious youth is enhanced by teaching parents to become their anxious child's CBT coach.
Children (7-17 years old) with either Generalized Anxiety Disorder, Social Phobia, or Separation Anxiety Disorder are treated with a combination of the Coping Cat Program and a parent-training intervention that is designed to teach the child's parents the same cognitive and behavioral skills that the child is learning and how to help their child to complete exposure activities.
The research methods are parallel to those used in the CAMS study so that this data can be merged with that data set to evaluate the relative efficacy of the enhanced intervention.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Children between the ages of 7 and 17 years old who are primarily experiencing either Generalized Anxiety Disorder, Separation Anxiety Disorder or Social Phobia and are not experiencing a cognitive or learning disability that would prevent them from validly completing the measures are eligible for participation in the study.
Children who are experiencing another psychological disorder as their primary disorder would be excluded from the current investigation.
Outcome measures include the ADIS for Diagnostic and Statistical Manual (fourth edition)(DSM-IV( Child or Parent, Children's Global Improvement Scale (CGI-I), Children's Global Assessment Scale (CGAS), Pediatric Anxiety Rating Scale (PARS), Negative Affect Self-Statements Questionnaire (NASSQ), Coping Questionnaire (CQ), Goal Attainment Scale (GAS), Mood and Feelings Questionnaire (MFQ), Multi-dimensional Anxiety Scale for Children (MASC), Screen for Child Anxiety and Related Emotional Disorders (SCARED),Family Assessment Measure (third editions) (FAM-III Dyadic), Perception of Therapeutic Relationship (PTR), Satisfaction Questionnaire (SQ), Child Behavior Check List (CBCL), Family Burden Assessment Scale (BAS), Brief Symptom Index (BSI), State Trait Anxiety Inventory (STAI), Brief Family Assessment Measure (third editions (Brief FAM-III).
Study Type
Interventional
Enrollment (Anticipated)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kevin D Stark, Ph.D.
- Phone Number: 512-324-3315
- Email: kstark@austin.utexas.edu
Study Contact Backup
- Name: Kelly Banneyer, M.S.
- Phone Number: 512-324-3315
- Email: kelly.n.banneyer@gmail.com
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78731
- Recruiting
- Texas Child Study Center
-
Contact:
- Kevin D Stark, Ph.D.
- Phone Number: 512-324-3315
- Email: kstark@austin.utexas.edu
-
Contact:
- Kelly Banneyer, M.S.
- Phone Number: 512-324-3315
- Email: kelly.n.banneyer@gmail.com
-
Principal Investigator:
- Kevin D. Stark, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Child is between 7-17 years old
- Primary diagnosis of Generalized Anxiety Disorder
- Separation Anxiety Disorder, or Social Phobia.
Exclusion Criteria:
- Presence of Major Depression, suicidal risk, presence of a learning disability or cognitive deficit that would prevent the child from validly completing the measures
- Presence of another psychological disorder that is of primary significance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CBT plus Parent as CBT Coach Training
|
Standard CBT for treatment of anxiety disorders in youth is completed by the children while their primary caregiver receives training in the same cognitive behavioral skills, how to recognize when he or she is accommodating his or her child's anxiety, and how to create and implement exposure activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Anxiety Rating Scale measures change in severity of anxiety from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Interview measure of the severity of anxiety symptoms that is completed by the child and his or her primary caregiver.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Multidimensional Anxiety Scale for Children measures change in severity of anxiety from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Measure of severity of anxiety symptoms in children and adolescents.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Screen for Child Anxiety Related Emotional Disorders measures change in severity of anxiety and related co-morbid disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Measure of the severity of anxiety symptoms.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Clinical Global Severity and Improvement Scales measure change in severity of anxiety and co-morbid disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Assessment of initial severity of illness and extent of improvement over treatment and follow-ups.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Children's Global Assessment Scale measures change in severity of anxiety and co-morbid disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Assessment of the degree of overall functioning of the child participants.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Anxiety Disorders Schedule for DSM-IV: Child Version and Parent Version
Time Frame: Baseline(One week prior to starting treatment)
|
Interview measure of the presence and severity of various anxiety disorders and common co-existing disorders.
|
Baseline(One week prior to starting treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Assessment Measure III, Dyadic Relationship Scale measures change in perceived family environment from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Assess family relationships
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Child Behavior Checklist measures change in severity of internalizing and externalizing symptoms from the parent's perspective from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Broadband measure of child psychopathology
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Family Burden Assessment measures change in severity of the burden the child's anxiety disorder creates for the family from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Measure of the impact on the family of the child's anxiety disorder.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Brief Symptom Inventory measures change in severity of parental psychopathology from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Assess parental psychopathology
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
State Trait Anxiety Inventory measures change in severity of anxiety for parents from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Measures anxiety symptoms in parents.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Mood and Feelings Questionnaire measures change in severity of depressive symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Measure of depressive symptoms in the child participants
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Goal Attainment Scale measures goal attainment from baseline to post-treatment and assess maintenance of goal attainment at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Therapist sets five goals for the child patient and then tracks progress over the course of treatment.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Coping Questionnaire measures change in coping skills from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Assess for the presence of coping skills in the child participants.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Negative Affective Self-Statement Questionnaire measures change in negative cognitions from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Measure of negative cognitions in the child participants.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Harm to Self and Others Interview measures change in suicidal ideation, homicidal ideation and self-harming behaviors from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Time Frame: Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Assessment of suicidal, homicidal and self-harm behavior and ideation.
|
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of Therapeutic Relationship measures the participants' satisfaction with the therapeutic relationship at post-treatment and at the one year and two year follow-ups.
Time Frame: Post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Assesses the patient-therapist relationship from the patient's perspective.
|
Post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Satisfaction Questionnaire measures the degree of satisfaction the participants experience at post-treatment and at one and two year follow-up assessments.
Time Frame: Post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Assesses the extent to which the patients are satisfied with the treatment they received.
|
Post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin D. Stark, Ph.D., University of Texas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (ANTICIPATED)
February 1, 2019
Study Completion (ANTICIPATED)
February 1, 2019
Study Registration Dates
First Submitted
July 14, 2013
First Submitted That Met QC Criteria
June 8, 2014
First Posted (ESTIMATE)
June 10, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-05-0009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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