Saint Petersburg, Florida 33701


This nonrandomized pilot study is investigating the efficacy of a modularized treatment for anxiety in children ages 3-7 years old. Eligibility is determined at a baseline assessment, followed by a second baseline assessment one month later. The treatment protocol, Parent-training Intervention for Preschoolers with Anxiety (PIPA), is flexible and allows for individualized treatments based on a treatment algorithm, ensuring that sessions address the most pressing clinical needs of each child. Treatment consists of weekly 60-minute sessions delivered over the course of 12 weeks. Symptom change is tracked weekly during brief phone assessments and a post-treatment assessment will occur following the final treatment session, approximately 12 weeks after starting treatment. Finally, all participants will complete two follow-up assessments, occurring 1-month and 6-months after the final treatment session.

Study summary:

Early childhood mental illness is a growing public health concern, and can persist into adolescence and adulthood if left untreated. Anxiety disorders are among the most common psychiatric illnesses in preschool aged youth and place youth at significantly higher risk for anxiety, depression, substance abuse, conduct problems, and diminished academic/occupational and social/relational functioning later in life. Accordingly, there is increasing emphasis on early identification and intervention, before symptoms become entrenched to mitigate a trajectory towards longstanding impairment. Unfortunately, empirically supported treatments for preschoolers with anxiety are limited. The few studies to date have tended to focus on relatively homogeneous samples whose symptoms resemble those in adults (e.g., worries and fears). Anxiety can present in similar ways to adult anxiety, however can also present more broadly in young children. Young children with anxiety may also present with extreme rigidity, sensory hypersensitivity, 'meltdowns'/emotional dysregulation/temper tantrums, ritualistic/routine oriented behavior, and oppositional behavior in some context. By focusing narrowly, treatments have not been adapted for the full range of anxiety presentations in early childhood. Therefore, the proposed study evaluates a modular, parent-driven psychotherapy developed for preschool aged youth (3-7 years) with diagnostic levels of anxiety, as well as anxiety symptoms dimensionally. The treatment program, Parent-training Intervention for Preschoolers with Anxiety (PIPA), is based on empirically supported behavioral and parent-training principles as well as the investigators' recently published pilot study of preschoolers with obsessive compulsive disorder. Sixty youth will be treated during the study. PIPA focuses on exposure and response prevention therapy (E/RP) in the context of behavioral parent training, each of which have efficacy in youth with anxiety, including high functioning autism spectrum disorders (ASD). Certain parenting responses (e.g., overprotection, critical responding, accommodation of anxiety symptoms and avoidance) have been implicated in the etiology and maintenance of pediatric anxiety disorders and, in addition to E/RP, this intervention will target behavioral parent training and unhelpful parenting practices to support long-term outcomes. In addition, this study will investigate one surrogate biomarker of anxiety in young children, fear conditioning (or more specifically, resistance to extinction). Behavioral treatment of anxiety, including the proposed PIPA intervention, relies on principles of extinction. Children and adults with anxiety disorders have been shown to have poorer fear extinction; however, there are few studies in young children examining this phenomenon. The potential to understand fear extinction in young children has implications for improving treatment efficacy and altering the negative trajectory of youth with anxiety disorders. Eligibility will be determined at a baseline assessment. A second baseline assessment will occur one month later for those that qualify. This assessment will be used to control for symptom change due to the natural passage of time. Treatment will be delivered over 12 weeks and will include weekly 60-minute sessions. A brief phone call with an assessor each week will be used to track symptom change during treatment, and a post-treatment assessment will be conducted following the final treatment session, approximately 12 weeks later. Follow-up assessments will occur 1-month and 6-months following the final treatment session.


Inclusion Criteria: - Children aged 3 to 7 years - Anxiety-based concerns rated as a top problem on the Top Problems Assessment at initial assessment. Exclusion Criteria: - Report or evidence of severe intellectual disability or level 3 autism spectrum disorder (ASD) without accompanying intellectual/language impairment (mild ASD is not exclusionary). - Presence of clinical features requiring a higher level of care (inpatient or partial hospital treatment). - Unwillingness of parents to accompany their children for multiple study visits; - Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study. - Initiation of an antidepressant within the 12 weeks preceding study enrollment, antipsychotic within 8 weeks prior to study enrollment, changes in established psychotropic medications within 8 weeks before study enrollment, or any change in alternative medications that might have behavioral effects within 6 weeks prior to study baseline assessment. Youth may remain stable on medications during the study. - Ongoing reports of abuse/neglect or trauma reported as a primary concern. - Extreme aggression/risk behaviors (e.g., harming animals, fire starting, violence) suggestive of conduct disorder trajectory.

Study is Available At:

Original ID:

ACH-Preschool 2015



Secondary ID:

Study Acronym:

Brief Title:

Modular Treatment for Preschool Anxiety

Official Title:

Modular Treatment for Preschool Anxiety

Overall Status:


Study Phase:




Minimum Age:

3 Years

Maximum Age:

7 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of South Florida

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Adam B Lewin, Ph.D., ABPP
Principal Investigator
University of South Florida
Primary Contact:P. J Mutch, Ph.D.
Backup Contact:Adam B Lewin, Ph.D., ABPP

Study Dates

Start Date:October 2015
Completion Date:December 2019
Completion Type:Anticipated
Primary Completion Date:September 2019
Primary Completion Type:Anticipated
Verification Date:April 2018
Last Changed Date:April 30, 2018
First Received Date:July 15, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Anxiety Severity as measured by the Clinical Global Impression- Severity (CGI-S)
Time Frame:Assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment,
Safety Issues:False
Description:7-point clinician rating of severity of psychopathology
Outcome Type:Secondary Outcome
Measure:Child Diagnostic Presence as measured by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)
Time Frame:Assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment,
Safety Issues:False
Description:Semi-structured diagnostic interview used to assess possible diagnoses via parent report
Outcome Type:Secondary Outcome
Measure:Key Child Problems as assessed by Top Problems Assessment (TPA)
Time Frame:Assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment,
Safety Issues:False
Description:obtains ratings of severity of the top three problems as identified by parent report
Outcome Type:Primary Outcome
Measure:Anxiety Improvement as assessed by Clinical Global Impression- Improvement (CGI-I)
Time Frame:Rating after the final therapy session, approximately 12 weeks after starting treatment.
Safety Issues:False
Description:7-point clinician rating of improvement of psychopathology

Study Interventions

Intervention Type:Behavioral
Description:Parent-training Intervention for Preschoolers with Anxiety (PIPA) is a behaviorally based modular treatment program for emotional and behavioral problems in young children. 12 sixty minute sessions will be delivered weekly. This intervention employs a modular format following a treatment algorithm in which therapy modules are selected by the therapist and supervisor on a session-by-session basis to address the most pressing clinical needs. Minimum session requirements for parent training/educati
Arm Name:PIPA
Other Name:Cognitive behavioral therapy

Study Arms

Study Arm Type:Experimental
Arm Name:PIPA
Description:Modularized treatment for anxiety in children ages 3-7 years old

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Adam Lewin
Agency Class:Other
Agency Type:Collaborator
Agency Name:Johns Hopkins All Children's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

If you would like to be contacted by the clinical trial representative please fill out the form below.