Autism Clinical Trial - Primary Care Stepping Stones Triple P for Children

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02236650
Study type	Interventional
Source	St. Louis University
Contact
Status	Completed
Phase	N/A
Start date	July 2014
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05302167` - Molehill Mountain Feasibility Study.	N/A
Completed	`NCT04167839` - Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement	N/A
Terminated	`NCT04049981` - Investigation of Mechanisms of Action in Superpower Glass	Phase 1/Phase 2
Active, not recruiting	`NCT06080087` - Implementation Toolkit to Enhance EBP Among Marginalized Families	N/A
Recruiting	`NCT04107064` - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program	N/A
Completed	`NCT03206996` - Exposure Therapy for Auditory Sensitivity in Autism	N/A
Completed	`NCT01914393` - Pediatric Open-Label Extension Study	Phase 3
Completed	`NCT05588570` - Coaching Children With Anxiety and Autism Through Telehealth	N/A
Enrolling by invitation	`NCT06058104` - Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism	N/A
Completed	`NCT02847182` - Cord Blood Infusion for Children With Autism Spectrum Disorder	Phase 2
Withdrawn	`NCT02414451` - Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response	N/A
Completed	`NCT03002363` - The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance	Phase 1
Completed	`NCT02911194` - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)	N/A
Completed	`NCT02536365` - Sensory Integration Therapy in Autism: Mechanisms and Effectiveness	N/A
Completed	`NCT02508922` - Trial of Vitamin D3 Supplementation in Paediatric Autism	N/A
Completed	`NCT02720900` - Prebiotic Intervention for Autism Spectrum Disorders	N/A
Completed	`NCT02708290` - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Recruiting	`NCT02255565` - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study	Phase 4
Recruiting	`NCT01836562` - A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism	Phase 1/Phase 2
Completed	`NCT02154828` - Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Primary Care Stepping Stones Triple P for Children With Autism

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms