Skip to main content
OpenTrials
Completed

NCT Number: NCT00865306

Early Intervention for Children at Risk for Anxiety

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Number of Responders Based on Clinician Global Impression-Anxiety Improvement

    Time frame: Post-Treatment (6-months from baseline)

    Clinicians blind to treatment assignment rated the child's global improvement on anxiety, using the Clinician Global Impression-Anxiety Improvement scale (CGI-Anxiety, best value 1, worst value 7). Responders were considered those with "very much" or "much" improvement (CGI-Anxiety scores of 1 or 2)

Other outcomes

  1. Number of Children Free of Anxiety Disorders

    Time frame: Post-Treatment (6-months from baseline)

    Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.

  2. Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up

    Time frame: 1-Year Follow-Up

    Clinicians rated improvement on anxiety since baseline using the Clinical Global Impression-Anxiety Improvement scale (Best 1, Worst 7), with children considered responders if they were rated "1, very much improved" or "2, much improved." Note that rates for controls are for controls who were subsequently treated with CBT (after completing the wait-list control condition).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
1998
Primary completion
2005
Study completion
2005
First posted
Mar 19, 2009
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.