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Completed

NCT Number: NCT02051192

Brief Behavioral Treatment for Anxiety in Young Children

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorder, Not Otherwise Specified Anxiety Disorders Anxiety, Separation Communication Disorders Generalized Anxiety Disorder Language Disorders Mental Disorders Mutism Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Phobia, Social Phobia, Specific Phobic Disorders Selective Mutism Separation Anxiety Disorder Signs and Symptoms Social Phobia Specific Phobia Speech Disorders

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rothman Center for Pediatric Neuropsychiatry - University of South Florida

St. Petersburg, Florida, 33701, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Parent-Led Exposure Therapy

Behavioral

Therapists will work with families for 10 sessions, twice weekly. The first treatment session will be a 90 minute parent only psychoeducation and treatment preparation session. Each subsequent session will last up to 60 minutes and will consist of exposure therapy using developmentally appropriate modulated behavioral approaches such as Participant modeling (PM) and Reinforced practice (RP).

Other names: Brief Behavioral Treatment for Anxiety in Young Children

Treatment as Usual

Other

Patients randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice. These participants may also elect to receive no treatment at all during the TAU period.

Primary outcomes

  1. Pediatric Anxiety Rating Scale

    Time frame: after 5 weeks of treatment

    The PARS is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week.

  2. Clinical Global Impression - Severity

    Time frame: After 5 weeks of treatment

    The CGI-S is a 7-point clinician rating of severity of psychopathology anchored by 1 ("no illness") and 7 ("very severe").

  3. Clinical Global Improvement

    Time frame: After 5 weeks of treatment

    The CGI is a 7-point rating of treatment response anchored by 1 ("very much improved) and 7 ("very much worse"). Youth being rated by the IE as 1 ("very much improved") and 2 ("much improved") will be considered treatment responders.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

A Brief Behavioral Treatment for Anxiety in Young Children

Acronym: PLET

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 31, 2014
Registry last updated
Oct 6, 2016

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.

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