Early Intervention for Children at Risk for Anxiety - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital National Institute of Mental Health (NIMH)
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00865306

Purpose

The aim of this study was to develop and pilot a cognitive-behavioral parent-child intervention for 4-7-year-old children at risk for anxiety disorders.

The 20-session intervention was first piloted openly in 9 children (between 3/10/98 and 1/1/2001). The intervention was then tested in 65 children in a randomized controlled trial versus a monitoring-only wait-list control condition. Children had to either have an anxiety disorder, behavioral inhibition, or be the offspring of a parent with an anxiety disorder who had elevated symptoms of anxiety. In practice all children but one had at least one anxiety disorder at baseline. Children were blocked on presence or absence of parental anxiety disorder and randomized to the intervention or to a no-intervention wait-list control group. The intervention consisted of 6 parent-only sessions, 8-13 child-parent sessions, and a final parent session.

Post-trial assessments were conducted at six months, and at one-year follow-up. The hypotheses were that the children assigned to the intervention group would show significantly better improvement (measured via CGI Anxiety and absence of anxiety disorders) than children assigned to the wait-list condition.

Condition	Intervention
Anxiety Disorder	Behavioral: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	Early Intervention for Children at Risk for Anxiety

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

CGI-Anxiety [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment:	74
Study Start Date:	March 1998
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active CBT: Experimental	Behavioral: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents." This is a cognitive-behavioral intervention modeled loosely after Kendall's "Coping Cat," which includes 7 parent-only sessions and 8-13 child-only sessions. It focuses on helping parents learn strategies for coaching their child in coping with anxiety, and on teaching the child coping skills and carrying out exposure exercises in session and in parent-child homework assignments.
No intervention (wait-list controls): No Intervention

Arms

Assigned Interventions

Active CBT: Experimental

Behavioral: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."

This is a cognitive-behavioral intervention modeled loosely after Kendall's "Coping Cat," which includes 7 parent-only sessions and 8-13 child-only sessions. It focuses on helping parents learn strategies for coaching their child in coping with anxiety, and on teaching the child coping skills and carrying out exposure exercises in session and in parent-child homework assignments.

No intervention (wait-list controls): No Intervention

Eligibility

Ages Eligible for Study:	4 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The child is at risk for anxiety disorders, as indicated by at least one of the following:
the child has behavioral inhibition (as determined by observed behavioral assessment);
the child meets criteria for a DSM-IV or IIIR anxiety disorder (as determined by K-SADS-E with the mother); or
the child has both a parent with lifetime history of anxiety disorder (as determined by direct SCID-IV's with both parents) and the child has anxious symptomatology, as indicated by CBCL scale scores (T-scores) on Anxious/Depressed or Withdrawn of 55 or higher.
The child is between the ages of 4 and 7 years
The child and parent(s) have a working command of English

Exclusion Criteria:

Psychosis in parent or child
Suicidality in parent or child
Current alcohol or substance abuse in a parent
Mental retardation or pervasive developmental disorder in parent or child
Child in current psychiatric treatment
Child judged too uncooperative or distractible to take part in intervention
(In the controlled trial): Child judged clinically unable to wait six months for treatment. The following criteria are used in determining whether the child can wait for 6 months before receiving treatment:
Suicidal Ideation
Serious impairment in eating or sleeping habits
Severe social isolation
Severe impairment in school functioning or attendance
Severe symptoms of obsessive-compulsive disorder (OCD)
Clinical judgment based on the child's overall severity of symptoms and family functioning.
All judgments of severity of symptoms/impairment are based on a clinician review of the Kiddie-SADS-E and a clinical evaluation with the family.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865306

Locations

United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138

Sponsors and Collaborators

Massachusetts General Hospital

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Dina Hirshfeld-Becker, PhD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Dina Hirshfeld-Becker )
Study ID Numbers:	2000P000305, NIMH K08 001538
Study First Received:	March 17, 2009
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00865306 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Cognitive behavioral therapy
Anxiety
Preschoolers
Young Children

Parents
or
at risk for anxiety because of having behavioral inhibition, or
at risk for anxiety because of having a parent with history of an anxiety disorder and elevated CBCL withdrawn or anxious/depressed scores.

Study placed in the following topic categories:

Depression
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 06, 2009