An interventional study of Parent Psychoeducation and Turtle Program in Behavioral Inhibition and Anxiety, sponsored by University of Maryland, College Park. Completed at 1 site in United States. Open to participants aged 42 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University of Maryland, College Park · Not applicable, Interventional, and Treatment
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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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 51 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Maryland, College Park is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
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.
Behavioral: Turtle Program
Untreated comparison group during the study, received parent psychoeducation intervention after the active treatment group.
Behavioral: Parent Psychoeducation
6-session parent psychoeducation group on child anxiety, following their children's lead, and encouraging approach behaviors.
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.
Change in child anxiety disorder symptoms
Assessed with diagnostic interviews (Preschool Age Psychiatric Assessment) with parents
Time frame: Pre-treatment (baseline), post-treatment (week 8), and 2-month follow-up
Ran from Feb 2010 to primary completion in Nov 2012, 33 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 33 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Maryland, College Park