Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT02236650
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2014-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Care Stepping Stones Triple P for Children With Autism
Sponsor:
St. Louis University
Organization:
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 child's 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 (N=38) or b) Wait List Control (WLC; N=38). 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.
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 (N=38) or b) Wait List Control (WLC; N=38). 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:
False
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?: