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Primary Care Stepping Stones Triple P for Children With Autism

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Care Stepping Stones Triple P (PC-SS Triple P)
Treatment as Usual
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Parental Resilience, Parental Stress, Family Adaptation, Autistic Disorder, Behavior, Child Behavior, Child Development Disorders, Pervasive Developmental Disabilities, Caregivers, Parents, Parenting, Primary Health Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saint Louis University, Knights of Columbus Developmental Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Primary Care Stepping Stones Triple P

Wait List Control (WLC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).

Secondary Outcome Measures

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).
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).
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.

Full Information

First Posted
September 8, 2014
Last Updated
December 16, 2015
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT02236650
Brief Title
Primary Care Stepping Stones Triple P for Children With Autism
Official Title
A Pilot Study of Primary Care Stepping Stones Triple P for Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Parental Resilience, Parental Stress, Family Adaptation, Autistic Disorder, Behavior, Child Behavior, Child Development Disorders, Pervasive Developmental Disabilities, Caregivers, Parents, Parenting, Primary Health Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Care Stepping Stones Triple P
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control (WLC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Primary Care Stepping Stones Triple P (PC-SS Triple P)
Other Intervention Name(s)
Postive Parenting Program, Triple P, Stepping Stones Triple P, Stepping Stones Positive Parenting Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
Service as Usual
Intervention Description
Treatment as Usual for 4 weeks
Primary Outcome Measure Information:
Title
Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeks
Description
Measure conduct problem behavior in children between the ages of 2 and 16 years.
Time Frame
Baseline and 4 weeks
Title
Change from Baseline in Connor-Davidson Resilience Scale Score at 4 weeks
Description
General scale of resilience in adult populations with a bias towards coping with stress and adversity.
Time Frame
Baseline and 4 weeks
Title
Change from Baseline in Parent Stress Index - Short Form Score at 4 weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change from Baseline in Family Assessment Device score at 4 weeks
Description
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).
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Aberrant Behavior Checklist Score at 4 weeks
Description
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).
Time Frame
Baseline and 4 weeks
Title
Change from Baseline in The Parenting Scale Score at 4 weeks
Description
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).
Time Frame
Baseline and 4 weeks
Title
Change from Baseline in the Parenting Sense of Competence Scale Score at 4 weeks
Description
Measures parents' sense of confidence and satisfaction with their parenting and their self-efficacy in the parenting role.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra H. Zand, PhD
Organizational Affiliation
Saint Louis University School of Medicine, Department of Pediatrics, Division of Developmental Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University, Knights of Columbus Developmental Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Links:
URL
https://sites.google.com/a/slu.edu/debra-h-zand-ph-d/parent-child-intervention-research-team-p-chirt
Description
Family Research Collaborative - Autism & Parenting Resilience

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Primary Care Stepping Stones Triple P for Children With Autism

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