Brief Behavioral Treatment for Anxiety in Young Children

Completed · Phase 1/Phase 2

Conditions studied: Obsessive-compulsive Disorder, Social Phobia, Generalized Anxiety Disorder, Specific Phobia, Separation Anxiety Disorder, Selective Mutism, Anxiety Disorder, Not Otherwise Specified

In brief

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.

Key facts

Study ID

NCT02051192

Run by

University of South Florida

People needed

58

Starts

2014-01-01

Expected to finish

2016-08-01

Last updated by the study team

2016-10-06

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• • (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.

Where it is running

• Rothman Center for Pediatric Neuropsychiatry - University of South Florida — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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