Back to resultsBrief Behavioral Treatment for Anxiety in Young Children (PLET)
Primary Purpose
Obsessive-compulsive Disorder, Social Phobia, Generalized Anxiety Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Parent-Led Exposure Therapy
Treatment As Usual
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-compulsive Disorder focused on measuring 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
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.
Sites / Locations
- Rothman Center for Pediatric Neuropsychiatry - University of South Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parent-Led Exposure Therapy (PLET)
Treatment As Usual
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Pediatric Anxiety Rating Scale
The PARS is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week.
Clinical Global Impression - Severity
The CGI-S is a 7-point clinician rating of severity of psychopathology anchored by 1 ("no illness") and 7 ("very severe").
Clinical Global Improvement
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02051192
First Posted
January 29, 2014
Last Updated
October 5, 2016
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT02051192
Brief Title
Brief Behavioral Treatment for Anxiety in Young Children
Acronym
PLET
Official Title
A Brief Behavioral Treatment for Anxiety in Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent-Led Exposure Therapy (PLET)
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent-Led Exposure Therapy
Other Intervention Name(s)
Brief Behavioral Treatment for Anxiety in Young Children
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Intervention Description
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 Outcome Measure Information:
Title
Pediatric Anxiety Rating Scale
Description
The PARS is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week.
Time Frame
after 5 weeks of treatment
Title
Clinical Global Impression - Severity
Description
The CGI-S is a 7-point clinician rating of severity of psychopathology anchored by 1 ("no illness") and 7 ("very severe").
Time Frame
After 5 weeks of treatment
Title
Clinical Global Improvement
Description
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.
Time Frame
After 5 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rothman Center for Pediatric Neuropsychiatry - University of South Florida
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brief Behavioral Treatment for Anxiety in Young Children
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