NCT00509951

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

4.8 years

First QC Date

July 30, 2007

Last Update Submit

June 6, 2013

Conditions

Keywords

NeurosesEvidence-Based TreatmentClinical InvestigationYoung PatientsPhobic DisordersFearPhobias

Outcome Measures

Primary Outcomes (2)

  • Anxiety Disorders Interview Schedule for DSM-IV: Presence of Specific Phobia

    Measured at Year 1

  • Clinical Global Impression: Severity of Specific Phobia

    Measured at Year 1

Study Arms (2)

1

ACTIVE COMPARATOR

One-session exposure treatment (OST)

Behavioral: One-session exposure treatment

2

EXPERIMENTAL

Family-enhanced (augmented) OST

Behavioral: Augmented one-session exposure treatment

Interventions

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.

1

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.

Also known as: Family-enhanced OST
2

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Study Center

Blacksburg, Virginia, 24060, United States

Location

MeSH Terms

Conditions

Anxiety DisordersPhobia, SpecificNeurotic DisordersPhobic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Thomas H. Ollendick, PhD

    Department of Psychology, Virginia Tech

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Distinguished Professor

Study Record Dates

First Submitted

July 30, 2007

First Posted

August 1, 2007

Study Start

July 1, 2007

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations