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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Parent Psychoeducation | 6-session parent psychoeducation group on child anxiety, following their children's lead, and encouraging approach behaviors. |
| BEHAVIORAL | Turtle Program | The 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.