Family-Based Prevention Program for Childhood Anxiety

NCT00078728 | Completed Results DMC

• 1 other identifier: K23MH063427
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.

Conditions

Anxiety Disorders

Keywords

Anxiety

Outcome Measures

Primary Outcomes (2)

• 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.

  12 month

• 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.

  12 months

Study Arms (2)

Family-based anxiety prevention program

EXPERIMENTAL

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.

Behavioral: Family-Based Anxiety Prevention Program

Evaluation only

ACTIVE COMPARATOR

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.

Behavioral: Evaluation only

Interventions

Family-Based Anxiety Prevention Program BEHAVIORAL

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.

Family-based anxiety prevention program

Evaluation only BEHAVIORAL

Participants will undergo evaluations without active treatment for 8 weeks.

Evaluation only

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers with a current, primary anxiety disorder
• year old children without an anxiety disorder

You may not qualify if:

• Mothers that do not have a current, primary anxiety disorder
• year old children with an anxiety disorder
• year old children that are currently receiving treatment for anxiety that could interfere with the study

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

Of the 40 participants in the study, no adverse events occured or were reported.

Results Point of Contact

• Title: Golda Ginsburg, PhD,Professor
• Organization: The Johns Hopkins University School of Medicine

gginnsbu@jhmi.edu

410-955-1544

Study Officials

• Golda S. Ginsburg, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2004
• First Posted: March 8, 2004
• Study Start: September 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: February 7, 2018
• Results First Posted: December 16, 2013

Record last verified: 2018-01

Locations

US (1)