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Parent-Augmented Cognitive Behavioral Therapy to Treat Children With Specific Phobias

Primary Purpose

Anxiety Disorders, Specific Phobia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One-session exposure treatment
Augmented one-session exposure treatment
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Neuroses, Evidence-Based Treatment, Clinical Investigation, Young Patients, Phobic Disorders, Fear, Phobias

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Enrolled in a regular classroom setting
  • Possess at least an average intellectual ability as documented by school ability records
  • Meets DSM-IV criteria for specific phobia and scores 4 or above on the clinician severity rating scale of the ADIS-C/P
  • A parent or caregiver agrees to participate in the treatment
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • Significant medical disorder (e.g., cerebral palsy, deafness) that would interfere with study participation
  • Already receiving psychological treatment (with the exception of minimal intervention in the school setting)
  • Currently receiving psychotropic medication for a psychological disorder, with the exception of attention deficit hyperactivity disorder (ADHD). If the child is receiving stimulant or other medication for management of ADHD symptoms, it must be documented that pharmacological treatment has been stabilized.
  • Blood-injection-injury type of specific phobia

Sites / Locations

  • Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

One-session exposure treatment (OST)

Family-enhanced (augmented) OST

Outcomes

Primary Outcome Measures

Anxiety Disorders Interview Schedule for DSM-IV: Presence of Specific Phobia
Clinical Global Impression: Severity of Specific Phobia

Secondary Outcome Measures

Full Information

First Posted
July 30, 2007
Last Updated
June 6, 2013
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00509951
Brief Title
Parent-Augmented Cognitive Behavioral Therapy to Treat Children With Specific Phobias
Official Title
Augmented Treatment of Specific Phobias in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the effectiveness of two types of cognitive behavioral therapy, one-session exposure treatment and family-enhanced one-session exposure treatment, in treating children with specific phobias.
Detailed Description
A specific phobia is a fear of a particular object or situation. For many children, phobias result in considerable academic difficulties, social and personal distress, and interference in day-to-day activities. Physical symptoms typically accompany the intense anxiety caused by a specific phobia and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Phobias can persist a lifetime and may lead to other adult anxiety, mood, and substance use disorders. One-session exposure treatment (OST), a form of cognitive behavior therapy, has been considered a rapid and effective treatment for adults with a variety of specific phobias. Upward of 75 to 80% of adults treated with OST were considered diagnoses free following treatment. OST has proven useful in treating some children with specific phobias but not all. It is possible that parental factors may affect whether a child continues to experience a phobia and how well a child responds to treatment. For example, parents who are overly protective or have a phobia themselves may prevent their child from overcoming a specific phobia. Family-enhanced OST (augmented OST) involves the parents of affected children and provides the parents with strategies to assist their children in overcoming phobias. This study will compare the effectiveness of OST and augmented OST in treating children with specific phobias. This study will also evaluate how parental factors influence the expression and maintenance of phobias in children. Participants in this study will be randomly assigned to receive OST or augmented OST. Participants receiving OST will attend one extended treatment session, lasting up to 3 hours in duration. During this session, the child will be taught a number of cognitive and behavioral skills to deal effectively with the feared situation or object. The child will also be exposed to the feared situation or object in a highly structured, safe, and controlled manner. This treatment will only be delivered to the child and will not involve a parent or guardian. Participants receiving augmented OST will attend the same type of extended treatment session, but, in addition, their parent or guardian will attend a 3-hour session. During this session, parents will first be educated on specific phobias, including why phobias occur and how they are maintained over time. Next, parents will observe their child being treated from behind a one-way mirror for about 1 hour. During this time, a therapist will explain what the child's therapist is doing and discuss ways for parents to implement the treatment at home. Parents will then be asked to join their child and the therapist for the last hour of the child's session to assist the therapist with treatment. Outcomes will be assessed for all participants immediately after treatment and at 1-, 6-, and 12-month follow-up evaluations during which the presence of specific phobias will be measured. Parents will also be asked to provide information about their child's school grades and school attendance for the year prior to participating in the study and up to 1 year after the child completes the treatment. The child's teacher may be asked to complete a questionnaire regarding the child's behavior in school. All of the information collected will help to determine how much progress each child has made as a result of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Specific Phobia
Keywords
Neuroses, Evidence-Based Treatment, Clinical Investigation, Young Patients, Phobic Disorders, Fear, Phobias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
One-session exposure treatment (OST)
Arm Title
2
Arm Type
Experimental
Arm Description
Family-enhanced (augmented) OST
Intervention Type
Behavioral
Intervention Name(s)
One-session exposure treatment
Intervention Description
Participants receiving OST will attend one extended treatment session, lasting up to 3 hours in duration. During this session, the child will be taught a number of cognitive and behavioral skills to deal effectively with the feared situation or object. The child will also be exposed to the feared situation or object in a highly structured, safe, and controlled manner.
Intervention Type
Behavioral
Intervention Name(s)
Augmented one-session exposure treatment
Other Intervention Name(s)
Family-enhanced OST
Intervention Description
Family-enhanced OST (augmented OST) involves the parents of affected children and provides the parents with strategies to assist their children in overcoming phobias. Participants receiving augmented OST will attend the same type of extended treatment session, but, in addition, their parent or guardian will attend a 3-hour session.
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule for DSM-IV: Presence of Specific Phobia
Time Frame
Measured at Year 1
Title
Clinical Global Impression: Severity of Specific Phobia
Time Frame
Measured at Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled in a regular classroom setting Possess at least an average intellectual ability as documented by school ability records Meets DSM-IV criteria for specific phobia and scores 4 or above on the clinician severity rating scale of the ADIS-C/P A parent or caregiver agrees to participate in the treatment Parent or guardian willing to provide informed consent Exclusion Criteria: Significant medical disorder (e.g., cerebral palsy, deafness) that would interfere with study participation Already receiving psychological treatment (with the exception of minimal intervention in the school setting) Currently receiving psychotropic medication for a psychological disorder, with the exception of attention deficit hyperactivity disorder (ADHD). If the child is receiving stimulant or other medication for management of ADHD symptoms, it must be documented that pharmacological treatment has been stabilized. Blood-injection-injury type of specific phobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H. Ollendick, PhD
Organizational Affiliation
Department of Psychology, Virginia Tech
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Study Center
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States

12. IPD Sharing Statement

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Parent-Augmented Cognitive Behavioral Therapy to Treat Children With Specific Phobias

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