- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051192
Brief Behavioral Treatment for Anxiety in Young Children (PLET)
October 5, 2016 updated by: Adam Lewin, University of South Florida
A 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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St. Petersburg, Florida, United States, 33701
- Rothman Center for Pediatric Neuropsychiatry - University of South Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 7 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Parent-Led Exposure Therapy (PLET)
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).
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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:
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Active Comparator: Treatment As Usual
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Anxiety Rating Scale
Time Frame: after 5 weeks of treatment
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The PARS is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week.
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after 5 weeks of treatment
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Clinical Global Impression - Severity
Time Frame: After 5 weeks of treatment
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The CGI-S is a 7-point clinician rating of severity of psychopathology anchored by 1 ("no illness") and 7 ("very severe").
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After 5 weeks of treatment
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Clinical Global Improvement
Time Frame: After 5 weeks of treatment
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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.
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After 5 weeks of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
January 29, 2014
First Submitted That Met QC Criteria
January 29, 2014
First Posted (Estimate)
January 31, 2014
Study Record Updates
Last Update Posted (Estimate)
October 6, 2016
Last Update Submitted That Met QC Criteria
October 5, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Personality Disorders
- Neurodevelopmental Disorders
- Language Disorders
- Communication Disorders
- Speech Disorders
- Disease
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Anxiety Disorders
- Phobia, Social
- Phobic Disorders
- Anxiety, Separation
- Mutism
Other Study ID Numbers
- PLET-13-0634
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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