Primary Care Stepping Stones Triple P for Children With Autism

Study Overview
=================
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: 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. 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. 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.

Official Title
-----------------
A Pilot Study of Primary Care Stepping Stones Triple P for Children With Autism

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Behavioral: Primary Care Stepping Stones Triple P (PC-SS Triple P)
* Other: Treatment as Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent inclusion criteria: being at least 18 years of age Index child inclusion criteria: receives a Diagnostic and Statistical Manual V (DSM-V) diagnosis of Autism with mild or moderate severity within 12 months of study onset. age is > or equal to 24 months (2 years, 0 months) and < or equal to 155 months old (12 years, 11 months). Exclusion Criteria: Parent exclusion criteria: inability to provide informed consent. being non-English speaking. Index child exclusion criteria: being a ward of the State of Missouri. being a sibling of another study participant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Care Stepping Stones Triple P<br>Primary Care Stepping Stones Triple P program (PC-SS Triple P) - a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience. | Behavioral: Primary Care Stepping Stones Triple P (PC-SS Triple P)<br>* PC-SS Triple P is a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.<br>* Other names: Stepping Stones Positive Parenting Program;|
| Active Comparator: Wait List Control (WLC)<br>Wait List Control - Participants who will have access to treatment as usual services during the 4 weeks between baseline and 4 week assessment time points and then will have the opportunity to receive PC-SS Triple P. | Other: Treatment as Usual<br>* Treatment as Usual for 4 weeks<br>* Other names: Service as Usual;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeks | Measure conduct problem behavior in children between the ages of 2 and 16 years. | Baseline and 4 weeks | 
| Change from Baseline in Connor-Davidson Resilience Scale Score at 4 weeks | General scale of resilience in adult populations with a bias towards coping with stress and adversity. | Baseline and 4 weeks | 
| Change from Baseline in Parent Stress Index - Short Form Score at 4 weeks | Sources and different types of stress that every parent can experience. Provides information in 4 specific domains of parenting stress: Parental Distress, Parent-Child Dysfunctional Interaction, Difficult Child, and Total Stress. | Baseline and 4 weeks | 
| Change from Baseline in Family Assessment Device score at 4 weeks | Assesses family functioning on six different dimensions: Problem Solving (ability to resolve problems), Communication (exchange of clear and direct verbal information), Roles (division of responsibility for completing family tasks), Affective Responsiveness (ability to respond with appropriate emotion), Affective Involvement (degree to which family members are involved and interested in one another), and Behavior Control (manner used to express and maintain standards of behavior). | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Aberrant Behavior Checklist Score at 4 weeks | Assesses behavior problems in individuals with developmental disabilities across 5 domains: Irritability and Agitation (15 items) Lethargy and Social Withdrawal (16 items) Stereotypic Behavior (7 items) Hyperactivity and Noncompliance (16 items) and Inappropriate Speech (4 items). | Baseline and 4 weeks | 
| Change from Baseline in The Parenting Scale Score at 4 weeks | Measures dysfunctional discipline styles in parents by asking about the probability with which the parent uses particular discipline strategies. It yields four scores: Total score, Laxness (permissive, inconsistent discipline); Over-reactivity (harsh, emotional, authoritarian discipline and irritability); and Verbosity/Hostility (use of verbal or physical force). | Baseline and 4 weeks | 
| Change from Baseline in the Parenting Sense of Competence Scale Score at 4 weeks | Measures parents' sense of confidence and satisfaction with their parenting and their self-efficacy in the parenting role. | Baseline and 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parents, Parental Resilience, Parental Stress, Family Adaptation, Autistic Disorder, Behavior, Child Behavior, Child Development Disorders, Pervasive Developmental Disabilities, Caregivers, Parenting, Primary Health Care