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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Child Study Center
        • Contact:
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CBT plus Parent as CBT Coach Training
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-05-0009

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