Viewing Study NCT02236650



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Study NCT ID: NCT02236650
Status: COMPLETED
Last Update Posted: 2015-12-17
First Post: 2014-09-08

Brief Title: Primary Care Stepping Stones Triple P for Children With Autism
Sponsor: St Louis University
Organization: St Louis University

Study Overview

Official Title: A Pilot Study of Primary Care Stepping Stones Triple P for Children With Autism
Status: COMPLETED
Status Verified Date: 2015-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones Triple P PC-SS Triple P an empirically supported parent mediated intervention to improve the behavioral functioning of children newly diagnosed with Autism aged 2-12 years increase parental resilience and decrease parental stress
Detailed Description: Research literature exists on best practices for screening and diagnosing children with Autism However less is known about how to intervene with the childs parent Across studies relative to parents of children without disabilities parents of children with Autism have reported higher levels of stress and lower levels of parenting competence Such stress places children at risk for adverse developmental outcomes

The proposed study aims to determine the effectiveness of Primary Care Stepping Stones Triple P PC-SS Triple P an empirically supported parent mediated intervention to improve the behavioral functioning of children newly diagnosed with Autism aged 2-12 years increase parental resilience and decrease parental stress

The specific hypotheses include

1 Children whose parents receive PC-SS Triple P will demonstrate significantly greater improvements in their behavioral functioning than children of parents receiving Wait-list Control WLC at service closure
2 At service closure parents receiving the PC-SS Triple P intervention will be more resilient and demonstrate lower levels of stress than parents in the Wait-List Control WLC condition
3 Parenting resilience and levels of parental stress will be positively associated with improvements in child behavior

Seventy-six parents of children newly diagnosed with Autism will be randomized into one of two conditions a PC-SS Triple P N38 or b Wait List Control WLC N38 Study data will be collected with the assistance of a data collector appropriately trained in human subject rights protections

It is anticipated that the present project will assist in the development and use of evidence-based practices for working with parents of children newly diagnosed with Autism within pediatric settings

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None