Clinical Trials Directory

Trials / Completed

CompletedNCT03486860

A Multi-Method Early Intervention Program for Inhibited and Anxious Preschoolers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
University of Maryland, College Park · Academic / Other
Sex
All
Age
42 Months – 60 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALParent Psychoeducation6-session parent psychoeducation group on child anxiety, following their children's lead, and encouraging approach behaviors.
BEHAVIORALTurtle ProgramThe Turtle Program involves a child social and emotional skills group (Social Skills Facilitated Play) and a modification of Parent-Child Interaction Therapy in which parents are provided in-vivo coaching in following their children's lead and encouraging approach behaviors within the peer context. The child group provides a forum of same-age peers to learn to develop social and emotion regulation skills. The Turtle Program is administered over an 8-week period.

Timeline

Start date
2010-02-01
Primary completion
2012-11-30
Completion
2012-11-30
First posted
2018-04-03
Last updated
2023-05-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03486860. Inclusion in this directory is not an endorsement.