Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160444
Recruitment Status : Unknown
Verified May 2016 by Kevin D. Stark, University of Texas at Austin.
Recruitment status was:  Recruiting
First Posted : June 10, 2014
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Kevin D. Stark, University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: CBT plus Parent as CBT Coach Training Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Effects of an Added Parent Component to Cognitive Behavior Therapy for Youth With Anxiety Disorders
Study Start Date : June 2012
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: CBT plus Parent as CBT Coach Training
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160444


Contacts
Layout table for location contacts
Contact: Kevin D Stark, Ph.D. 512-324-3315 kstark@austin.utexas.edu
Contact: Kelly Banneyer, M.S. 512-324-3315 kelly.n.banneyer@gmail.com

Locations
Layout table for location information
United States, Texas
Texas Child Study Center Recruiting
Austin, Texas, United States, 78731
Contact: Kevin D Stark, Ph.D.    512-324-3315    kstark@austin.utexas.edu   
Contact: Kelly Banneyer, M.S.    512-324-3315    kelly.n.banneyer@gmail.com   
Principal Investigator: Kevin D. Stark, Ph.D.         
Sponsors and Collaborators
University of Texas at Austin
Investigators
Layout table for investigator information
Principal Investigator: Kevin D. Stark, Ph.D. University of Texas
Additional Information:
Layout table for additonal information
Responsible Party: Kevin D. Stark, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02160444    
Other Study ID Numbers: 2012-05-0009
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Kevin D. Stark, University of Texas at Austin:
CBT
Parent Training
Anxiety Disorders in Children
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders