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Family-Based Prevention Program for Childhood Anxiety

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Based Anxiety Prevention Program
Evaluation only
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorders focused on measuring Anxiety

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mothers with a current, primary anxiety disorder 7-12 year old children without an anxiety disorder Exclusion Criteria: Mothers that do not have a current, primary anxiety disorder 7-12 year old children with an anxiety disorder 7-12 year old children that are currently receiving treatment for anxiety that could interfere with the study

Sites / Locations

  • Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family-based anxiety prevention program

Evaluation only

Arm Description

Participants will complete an 8 session (1 session/week), cognitive behavioral therapy-based, family prevention program to be administered by a trained clinician, after randomization to the study. The prevention program will include 3 booster sessions that take place after the first 8 sessions.

Waitlist control group. Participants in this group will receive general information (in the form of a printed packet) about anxiety after randomization to the study. Families in this group will complete all study evaluations and will then be offered the option of participating in the prevention program. Families who accept will begin the prevention sessions and will receive the same CBT-based, family-based prevention program as the other treatment arm.

Outcomes

Primary Outcome Measures

Number of Children With Child Anxiety Diagnosis
Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.
Child Anxiety Diagnoses
The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2004
Last Updated
January 29, 2018
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00078728
Brief Title
Family-Based Prevention Program for Childhood Anxiety
Official Title
Family-Based Prevention for Childhood Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.
Detailed Description
Anxiety disorders are serious conditions that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care. Participants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after intervention completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after intervention completion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Anxiety

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Family-based anxiety prevention program
Arm Type
Experimental
Arm Description
Participants will complete an 8 session (1 session/week), cognitive behavioral therapy-based, family prevention program to be administered by a trained clinician, after randomization to the study. The prevention program will include 3 booster sessions that take place after the first 8 sessions.
Arm Title
Evaluation only
Arm Type
Active Comparator
Arm Description
Waitlist control group. Participants in this group will receive general information (in the form of a printed packet) about anxiety after randomization to the study. Families in this group will complete all study evaluations and will then be offered the option of participating in the prevention program. Families who accept will begin the prevention sessions and will receive the same CBT-based, family-based prevention program as the other treatment arm.
Intervention Type
Behavioral
Intervention Name(s)
Family-Based Anxiety Prevention Program
Intervention Description
Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks. The intervention will begin immediately after randomization to the study.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation only
Intervention Description
Participants will undergo evaluations without active treatment for 8 weeks.
Primary Outcome Measure Information:
Title
Number of Children With Child Anxiety Diagnosis
Description
Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.
Time Frame
12 month
Title
Child Anxiety Diagnoses
Description
The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mothers with a current, primary anxiety disorder 7-12 year old children without an anxiety disorder Exclusion Criteria: Mothers that do not have a current, primary anxiety disorder 7-12 year old children with an anxiety disorder 7-12 year old children that are currently receiving treatment for anxiety that could interfere with the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Golda S. Ginsburg, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Family-Based Prevention Program for Childhood Anxiety

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