Early Intervention for Children at Risk for Anxiety

NCT ID: NCT00865306

Last Updated: 2010-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-03-31
• Study Completion Date: 2005-01-31

Brief Summary

The aim of this study was to develop and pilot a cognitive-behavioral therapy (CBT) 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 Clinician Global Impression-Anxiety Improvement scale and absence of anxiety disorders) than children assigned to the wait-list condition.

Conditions

Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active CBT

Seven parent-only and 8-13 child-only sessions focusing on CBT for anxiety disorders using the "Being Brave" protocol.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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)

Control children received no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"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.

Intervention Type: BEHAVIORAL

Eligibility 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 Kiddie-Schedule for Affective Disorders and Schizophrenia, Epidemiologic Version [K-SADS-E] with the mother); or
• the child has both a parent with lifetime history of anxiety disorder (as determined by direct Structured Clinical Interview for DSM-IV [SCID-IV] with both parents) and the child has anxious symptomatology, as indicated by Child Behavior Checklist [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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Massachusetts General Hospital

Principal Investigators

Dina Hirshfeld-Becker, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Cambridge, Massachusetts, United States

Countries

United States

References

Hirshfeld-Becker DR, Masek B, Henin A, Blakely LR, Pollock-Wurman RA, McQuade J, DePetrillo L, Briesch J, Ollendick TH, Rosenbaum JF, Biederman J. Cognitive behavioral therapy for 4- to 7-year-old children with anxiety disorders: a randomized clinical trial. J Consult Clin Psychol. 2010 Aug;78(4):498-510. doi: 10.1037/a0019055.

Reference Type: RESULT

PMID: 20658807 (View on PubMed)

Other Identifiers

K08MH001538

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000P000305

Identifier Type: -

Identifier Source: org_study_id