Anxiety DisordersNCT02160444
Investigating the Effects of Parent Component to Cognitive Behavior Therapy (CBT) for Youth With Anxiety Disorders
A study testing CBT plus Parent as CBT Coach Training in people with Anxiety Disorders, run by University of Texas at Austin at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- CBT plus Parent as CBT Coach Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Feb 2019
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is between 7-17 years old
- Primary diagnosis of Generalized Anxiety Disorder
- Separation Anxiety Disorder, or Social Phobia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Child Study Center
Austin, Texas, 78731
Kevin D Stark, Ph.D., 512-324-3315, kstark@austin.utexas.edu
Kelly Banneyer, M.S., 512-324-3315, kelly.n.banneyer@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Anxiety Disorders
- Being tested
- CBT plus Parent as CBT Coach Training
- Keywords
- CBT, Parent Training, Anxiety Disorders in Children
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT plus Parent as CBT Coach TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT plus Parent as CBT Coach Training | Experimental | CBT plus Parent as CBT Coach Training Receives: Behavioral: CBT plus Parent as CBT Coach Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Interview measure of the severity of anxiety symptoms that is completed by the child and his or her primary caregiver.
Measured: 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.
Measure of severity of anxiety symptoms in children and adolescents.
Measured: 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.
Measure of the severity of anxiety symptoms.
Measured: 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.
Assessment of initial severity of illness and extent of improvement over treatment and follow-ups.
Measured: 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.
Assessment of the degree of overall functioning of the child participants.
Measured: 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
Interview measure of the presence and severity of various anxiety disorders and common co-existing disorders.
Measured: Baseline(One week prior to starting treatment)
Secondary outcomes (10)
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.
Assess family relationships
Measured: 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.
Broadband measure of child psychopathology
Measured: 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.
Measure of the impact on the family of the child's anxiety disorder.
Measured: 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.
Assess parental psychopathology
Measured: 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.
Measures anxiety symptoms in parents.
Measured: 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.
Measure of depressive symptoms in the child participants
Measured: 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.
Therapist sets five goals for the child patient and then tracks progress over the course of treatment.
Measured: 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.
Assess for the presence of coping skills in the child participants.
Measured: 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.
Measure of negative cognitions in the child participants.
Measured: 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.
Assessment of suicidal, homicidal and self-harm behavior and ideation.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJun 2012
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin D. Stark, University of Texas at Austin
- Investigators
- Kevin D. Stark, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160444
- Sponsor's protocol ID
- 2012-05-0009
- Status last verified
- May 2016
- First submitted
- 14 Jul 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of an Added Parent Component to Cognitive Behavior Therapy for Youth With Anxiety Disorders
- ClinicalTrials.gov ID
- NCT02160444
- Acronym / sponsor ID
- 2012-05-0009
- Conditions
- Anxiety Disorders
- Keywords
- CBT, Parent Training, Anxiety Disorders in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 10 Jun 2014 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT plus Parent as CBT Coach Training | Experimental | Behavioral: CBT plus Parent as CBT Coach TrainingCBT plus Parent as CBT Coach Training |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child is between 7-17 years old
- Primary diagnosis of Generalized Anxiety Disorder
- Separation Anxiety Disorder, or Social Phobia.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| CBT plus Parent as CBT Coach TrainingStandard 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. | Behavioural | CBT plus Parent as CBT Coach Training |
Primary outcome
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.
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.
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.
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.
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.
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.
10 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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.
Kevin D. Stark, Ph.D. principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT plus Parent as CBT Coach Training in people with Anxiety Disorders, run by University of Texas at Austin 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 2 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: status not confirmed, as of the sponsor's last update on 12 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin D Stark, Ph.D. (512-324-3315, kstark@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2016.