Modular Treatment for Preschool Anxiety

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 Overview

• Status: Unknown
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: PIPA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33701
      • Rothman Center for Pediatric Neuropsychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PIPA; Modularized treatment for anxiety in children ages 3-7 years old

Behavioral: PIPA; 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/education and fear hierarchy/exposure are set to insure adequate dose of core exposure and response prevention for anxiety across cases.; Other Names: Cognitive behavioral therapy; Exposure and response prevention; Parent training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Improvement as assessed by Clinical Global Impression- Improvement (CGI-I)	7-point clinician rating of improvement of psychopathology	Rating after the final therapy session, approximately 12 weeks after starting treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key Child Problems as assessed by Top Problems Assessment (TPA)	obtains ratings of severity of the top three problems as identified by parent report	Assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment, 6-months after completion of treatment
Child Diagnostic Presence as measured by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)	Semi-structured diagnostic interview used to assess possible diagnoses via parent report	Assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment, 6-months after completion of treatment
Anxiety Severity as measured by the Clinical Global Impression- Severity (CGI-S)	7-point clinician rating of severity of psychopathology	Assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment, 6-months after completion of treatment

Collaborators and Investigators

• Sponsor: Adam Lewin
• Collaborators: Johns Hopkins All Children's Hospital
• Investigators: Principal Investigator: Adam B Lewin, Ph.D., ABPP, University of South Florida

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 29, 2015

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; anxiety; preschool; modular; exposure and response prevention
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ACH-Preschool 2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No