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New therapy helps anxious kids before problems grow

NCT ID NCT00865306

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a therapy program called 'Being Brave' for children ages 4 to 7 who were at risk for anxiety disorders. The program involved parents and children learning coping skills together. Researchers compared 65 children who received the therapy to those on a waitlist. Results showed that children in the therapy group had greater improvement in anxiety symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cognitive-behavioral therapy (CBT) program called 'Being Brave'
What this could lead to
If successful, this could provide an effective early intervention to reduce anxiety in young children and prevent long-term issues.
What could go wrong
This was a small pilot study with only 65 children, so results may not apply to everyone. The intervention requires significant parent involvement, which may not work for all families.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

65 people

The number who actually took part.

Start date

Mar 1998

Finished

Jan 2005

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 7 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Massachusetts General Hospital

    Cambridge, Massachusetts, 02138, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.