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PIPA for Anxiety

N/A
Waitlist Available
Led By Adam B Lewin, Ph.D., ABPP
Research Sponsored by Adam Lewin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment, 6-months after completion of treatment
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Anxiety

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment, 6-months after completion of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment, 6-months after completion of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety Improvement as assessed by Clinical Global Impression- Improvement (CGI-I)
Secondary outcome measures
Anxiety Severity as measured by the Clinical Global Impression- Severity (CGI-S)
Child Diagnostic Presence as measured by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)
Key Child Problems as assessed by Top Problems Assessment (TPA)

Trial Design

1Treatment groups
Experimental Treatment
Group I: PIPAExperimental Treatment1 Intervention
Modularized treatment for anxiety in children ages 3-7 years old

Find a Location

Who is running the clinical trial?

Adam LewinLead Sponsor
Johns Hopkins All Children's HospitalOTHER
43 Previous Clinical Trials
5,007,479 Total Patients Enrolled
Adam B Lewin, Ph.D., ABPPPrincipal InvestigatorUniversity of South Florida

Frequently Asked Questions

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~6 spots leftby Apr 2025