NCT02160444

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

6.7 years

First QC Date

July 14, 2013

Last Update Submit

May 10, 2016

Conditions

Anxiety Disorders

Keywords

CBTParent TrainingAnxiety Disorders in Children

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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)

  • +5 more secondary outcomes

Other Outcomes (2)

  • 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.

    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.

    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)

Study Arms (1)

CBT plus Parent as CBT Coach Training

EXPERIMENTAL

CBT plus Parent as CBT Coach Training

Behavioral: CBT plus Parent as CBT Coach Training

Interventions

CBT plus Parent as CBT Coach TrainingBEHAVIORAL

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.

CBT plus Parent as CBT Coach Training

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child is between 7-17 years old
  • Primary diagnosis of Generalized Anxiety Disorder
  • Separation Anxiety Disorder, or Social Phobia.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Child Study Center

Austin, Texas, 78731, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Kevin D. Stark, Ph.D.

    University of Texas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin D Stark, Ph.D.

CONTACT

512-324-3315kstark@austin.utexas.edu

Kelly Banneyer, M.S.

CONTACT

512-324-3315kelly.n.banneyer@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2013

First Posted

June 10, 2014

Study Start

June 1, 2012

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(1)