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Investigating the Effects of Parent Component to Cognitive Behavior Therapy (CBT) for Youth With Anxiety Disorders

Primary Purpose

Anxiety Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT plus Parent as CBT Coach Training
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring CBT, Parent Training, Anxiety Disorders in Children

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Child Study CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT plus Parent as CBT Coach Training

Arm Description

CBT plus Parent as CBT Coach Training

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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
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
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.
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
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.
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
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.
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.
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.
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.

Full Information

First Posted
July 14, 2013
Last Updated
May 10, 2016
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT02160444
Brief Title
Investigating the Effects of Parent Component to Cognitive Behavior Therapy (CBT) for Youth With Anxiety Disorders
Official Title
Investigating the Effects of an Added Parent Component to Cognitive Behavior Therapy for Youth With Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
CBT, Parent Training, Anxiety Disorders in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT plus Parent as CBT Coach Training
Arm Type
Experimental
Arm Description
CBT plus Parent as CBT Coach Training
Intervention Type
Behavioral
Intervention Name(s)
CBT plus Parent as CBT Coach Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Interview measure of the severity of anxiety symptoms that is completed by the child and his or her primary caregiver.
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)
Title
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.
Description
Measure of severity of anxiety symptoms in children and adolescents.
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)
Title
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.
Description
Measure of the severity of anxiety symptoms.
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)
Title
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.
Description
Assessment of initial severity of illness and extent of improvement over treatment and follow-ups.
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)
Title
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.
Description
Assessment of the degree of overall functioning of the child participants.
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)
Title
Anxiety Disorders Schedule for DSM-IV: Child Version and Parent Version
Description
Interview measure of the presence and severity of various anxiety disorders and common co-existing disorders.
Time Frame
Baseline(One week prior to starting treatment)
Secondary Outcome Measure Information:
Title
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.
Description
Assess family relationships
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)
Title
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.
Description
Broadband measure of child psychopathology
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)
Title
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.
Description
Measure of the impact on the family of the child's anxiety disorder.
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)
Title
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.
Description
Assess parental psychopathology
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)
Title
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.
Description
Measures anxiety symptoms in parents.
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)
Title
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.
Description
Measure of depressive symptoms in the child participants
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)
Title
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.
Description
Therapist sets five goals for the child patient and then tracks progress over the course of treatment.
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)
Title
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.
Description
Assess for the presence of coping skills in the child participants.
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)
Title
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.
Description
Measure of negative cognitions in the child participants.
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)
Title
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.
Description
Assessment of suicidal, homicidal and self-harm behavior and ideation.
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)
Other Pre-specified Outcome Measures:
Title
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.
Description
Assesses the patient-therapist relationship from the patient's perspective.
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)
Title
Satisfaction Questionnaire measures the degree of satisfaction the participants experience at post-treatment and at one and two year follow-up assessments.
Description
Assesses the extent to which the patients are satisfied with the treatment they received.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin D Stark, Ph.D.
Phone
512-324-3315
Email
kstark@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Banneyer, M.S.
Phone
512-324-3315
Email
kelly.n.banneyer@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin D. Stark, Ph.D.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Child Study Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin D Stark, Ph.D.
Phone
512-324-3315
Email
kstark@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Kelly Banneyer, M.S.
Phone
512-324-3315
Email
kelly.n.banneyer@gmail.com
First Name & Middle Initial & Last Name & Degree
Kevin D. Stark, Ph.D.

12. IPD Sharing Statement

Links:
URL
http://www.dellchildrens.net/services_and_programs/texas_child_study_center__mental_health_services/
Description
Link for the Texas Child Study Center

Learn more about this trial

Investigating the Effects of Parent Component to Cognitive Behavior Therapy (CBT) for Youth With Anxiety Disorders

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