Modular Treatment for Preschool Anxiety

Status unconfirmed · Not applicable

Conditions studied: Anxiety

In brief

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.

Key facts

Study ID

NCT02510391

Run by

Adam Lewin

People needed

60

Starts

2015-10-01

Expected to finish

2020-12-01

Last updated by the study team

2020-04-24

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 3 to 7 years
• Anxiety-based concerns rated as a top problem on the Top Problems Assessment at initial assessment.

You may not qualify if…

• 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.

Where it is running

• Rothman Center for Pediatric Neuropsychiatry — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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