Clinical trial NCT02051192: Brief Behavioral Treatment for Anxiety in Young Children
Official title: A Brief Behavioral Treatment for Anxiety in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obsessive-compulsive Disorder
Social Phobia
Generalized Anxiety Disorder
Specific Phobia
Separation Anxiety Disorder
Selective Mutism
Anxiety Disorder, Not Otherwise Specified
Keywords: obsessive-compulsive disorder
Social phobia
Generalized anxiety disorder
Specific phobia
Separation anxiety disorder
Selective Mutism
Anxiety Disorder, Not Otherwise Specified
Counseling
Behavioral therapy
Psychotherapy
Exposure
Young Children
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 58
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Behaviorally and cognitive-behaviorally based therapeutic techniques (BT; CBT) that incorporate exposure therapy useful for treatment of anxiety disorders among typically developing children. Although a large amount of data demonstrate the effectiveness of of BT and CBT approaches for treating anxious youth, there is a gap in the literature for the effectiveness of these approaches for children under the age of seven. Evidence increasingly suggests that family factors such as accommodation and parenting style contribute significantly to the presence of anxiety symptoms as well as treatment outcomes, particularly in young children. These findings stress the importance of using a treatment approach in which parents are directly involved in education, parent training, and generalization of treatment effects. Therefore, this study aims to evaluate a new treatment program, parent-led behavioral treatment, for children ages 3 to 7 years of age who have a principal anxiety disorder diagnosis.


Eligibility criteria: Inclusion Criteria:

* Outpatient children between the ages 3-7 years.
* Meets DSM-IV criteria for a primary diagnosis of an anxiety disorder or achieves a minimum score of 12 Pediatric Anxiety Rating Scale (PARS)
* Child has a PPVT IV SS \> 80.
* Patients with co-morbid depression, ADHD, tic disorder or disruptive behavior disorders will be included as long as anxiety is primary (i.e., most impairing/distressing).

Exclusion Criteria:

* • (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.

  * Receiving concurrent psychotherapy, social skills training, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study. Those randomized treatment as usual (TAU) will be able to continue or initiate psychosocial interventions (psychotherapy, social skills training, applied behavior analysis, or family therapy) whereas those randomized to PLET will not receive these interventions concurrent with PLET.
  * Any change in established psychotropic medication (e.g., antidepressants, anxioloytics, antipsychotics, stimulants) within 10 weeks before study. Those randomized to TAU may make medication changes following randomization, including starting a medication; those randomized to PLET will remain stable on medications during the study.
  * Absence of language.
  * A formal diagnosis of mental retardation or autism spectrum disorder.
  * Unwillingness of parents to make the commitment to accompany their child for multiple study visits, unwillingness to take part in randomization, inability to attend sessions twice weekly as therapist availability allows, inability to attend assessment visits.
  * Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.

Primary outcomes:
measure: Pediatric Anxiety Rating Scale
timeFrame: after 5 weeks of treatment
measure: Clinical Global Impression - Severity
timeFrame: After 5 weeks of treatment
measure: Clinical Global Improvement
timeFrame: After 5 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Rothman Center for Pediatric Neuropsychiatry - University of South Florida
state: Florida
Study officials:
References: