A Multi-Method Early Intervention Program for Inhibited and Anxious Preschoolers
- Conditions
- Behavioral InhibitionAnxiety
- Registration Number
- NCT03486860
- Lead Sponsor
- University of Maryland, College Park
- Brief Summary
This project aims to develop and evaluate a novel early intervention program that targets the specific risk factors implicated in the development and persistence of shyness, social reticence, and withdrawal in children. The project includes a program development phase, Phase I (pilot test of full study procedures using developed treatment protocol), and Phase II (randomized controlled trial/RCT). Outcomes that will be assessed include change in child behavioral inhibition and parenting, using parent and teacher reports and observational data. Families are assessed at three time points: baseline, post-treatment (or at approximately 8 weeks for the control group), and 2 month follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire; child has a biological parent with at least 50% physical custody who consents to participate
- Child has a diagnosis of pervasive developmental disorder or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in child anxiety disorder symptoms Pre-treatment (baseline), post-treatment (week 8), and 2-month follow-up Assessed with diagnostic interviews (Preschool Age Psychiatric Assessment) with parents
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Maryland
🇺🇸College Park, Maryland, United States
University of Maryland🇺🇸College Park, Maryland, United States