Primary Care Stepping Stones Triple P for Children With Autism

December 16, 2015 updated by: Debra H. Zand, Ph.D., St. Louis University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Saint Louis University, Knights of Columbus Developmental Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary Care Stepping Stones Triple P
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)
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.
Other Names:
  • Triple P
  • Postive Parenting Program
  • Stepping Stones Triple P
  • Stepping Stones Positive Parenting Program
Active Comparator: Wait List Control (WLC)
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
Treatment as Usual for 4 weeks
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
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and 4 weeks

Sources and different types of stress that every parent can experience. Provides information in 4 specific domains of parenting stress:

  1. Parental Distress,
  2. Parent-Child Dysfunctional Interaction,
  3. Difficult Child, and
  4. Total Stress.
Baseline and 4 weeks
Change from Baseline in Family Assessment Device score at 4 weeks
Time Frame: Baseline and 4 weeks

Assesses family functioning on six different dimensions:

  1. Problem Solving (ability to resolve problems),
  2. Communication (exchange of clear and direct verbal information),
  3. Roles (division of responsibility for completing family tasks),
  4. Affective Responsiveness (ability to respond with appropriate emotion),
  5. Affective Involvement (degree to which family members are involved and interested in one another), and
  6. 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
Time Frame: Baseline and 4 weeks

Assesses behavior problems in individuals with developmental disabilities across 5 domains:

  1. Irritability and Agitation (15 items)
  2. Lethargy and Social Withdrawal (16 items)
  3. Stereotypic Behavior (7 items)
  4. Hyperactivity and Noncompliance (16 items) and
  5. Inappropriate Speech (4 items).
Baseline and 4 weeks
Change from Baseline in The Parenting Scale Score at 4 weeks
Time Frame: Baseline and 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:

  1. Total score,
  2. Laxness (permissive, inconsistent discipline);
  3. Over-reactivity (harsh, emotional, authoritarian discipline and irritability); and
  4. 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
Time Frame: Baseline and 4 weeks
Measures parents' sense of confidence and satisfaction with their parenting and their self-efficacy in the parenting role.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Investigators

  • Principal Investigator: Debra H. Zand, PhD, Saint Louis University School of Medicine, Department of Pediatrics, Division of Developmental Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLUBM_24272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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