Anxiety Disorder
Conditions
Keywords
Cognitive behavioral therapy, Anxiety, Preschoolers, Young Children, Parents, At-risk, Behavioral Inhibition
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.
Interventions
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.
Sponsors
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders Based on Clinician Global Impression-Anxiety Improvement | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDina Hirshfeld-Becker, PhD
Massachusetts General Hospital
Participant flow
Recruitment details
Study recruitment for the controlled trial occurred between February 2001 and January 2004. Children were recruited from the outpatient child psychiatry clinic at a general hospital, as well as through print ads in local newspapers and parent magazines, email advertisements to hospital employees, and posters at local pediatrics practices.
Pre-assignment details
We screened 103 children for the controlled trial, to enroll our target goal of 60-65 children. Of these 14 were ineligible (3 did not meet inclusion criteria, and 9 met exclusion criteria). Another 13 withdrew prior to completing baseline assessments, and 11 who did not complete baseline assessments were lost to follow-up. Thus 65 were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Active CBT | 34 |
| No Intervention (Wait-list Controls) | 30 |
| Total | 64 |
Baseline characteristics
| Characteristic | No Intervention (Wait-list Controls) | Active CBT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 34 Participants | 64 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.4 years STANDARD_DEVIATION 1 | 5.4 years STANDARD_DEVIATION 1 | 5.4 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 30 participants | 34 participants | 64 participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 0 / 34 | 0 / 30 |
| serious Total, serious adverse events | 0 / 34 | 0 / 30 |
Outcome results
Primary
Number of Responders Based on Clinician Global Impression-Anxiety Improvement
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)
Time frame: Post-Treatment (6-months from baseline)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active CBT | Number of Responders Based on Clinician Global Impression-Anxiety Improvement | 20 Participants |
| No Intervention (Wait-list Controls) | Number of Responders Based on Clinician Global Impression-Anxiety Improvement | 9 Participants |
p-value: <0.05Chi-squared
Other Pre-specified
Number of Children Free of Anxiety Disorders
Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.
Time frame: Post-Treatment (6-months from baseline)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active CBT | Number of Children Free of Anxiety Disorders | 17 Participants |
| No Intervention (Wait-list Controls) | Number of Children Free of Anxiety Disorders | 5 Participants |
p-value: <0.01Chi-squared
Other Pre-specified
Number of Responders Using Clinical Global Impression-Anxiety Improvement at 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).
Time frame: 1-Year Follow-Up
Population: We tabulated the number of children that were much or very much improved on anxiety since baseline. Note that the controls who were followed up at one-year were those who subsequently received CBT (after participating in the wait-list condition). Therefore the No intervention (wait-list controls) followed up here had actually received CBT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active CBT | Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up | 24 Participants |
| No Intervention (Wait-list Controls) | Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up | 11 Participants |