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

NCT ID: NCT02160444

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBT plus Parent as CBT Coach Training

CBT plus Parent as CBT Coach Training

Group Type EXPERIMENTAL

CBT plus Parent as CBT Coach Training

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kevin D. Stark

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin D. Stark, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Texas Child Study Center

Austin, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kevin D Stark, Ph.D.

Role: CONTACT

512-324-3315

Kelly Banneyer, M.S.

Role: CONTACT

512-324-3315

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kevin D Stark, Ph.D.

Role: primary

512-324-3315

Kelly Banneyer, M.S.

Role: backup

512-324-3315

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-05-0009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.