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Completed

NCT Number: NCT02236650

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Behavior Child Behavior Child Development Disorders, Pervasive Developmental Disabilities Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University, Knights of Columbus Developmental Center

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary Care Stepping Stones Triple P (PC-SS Triple P)

Behavioral

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: Postive Parenting Program, Triple P, Stepping Stones Triple P, Stepping Stones Positive Parenting Program

Treatment as Usual

Other

Treatment as Usual for 4 weeks

Other names: Service as Usual

Primary outcomes

  1. 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.

  2. 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.

  3. 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:

    • Parental Distress,
    • Parent-Child Dysfunctional Interaction,
    • Difficult Child, and
    • Total Stress.

  4. Change from Baseline in Family Assessment Device score at 4 weeks

    Time frame: Baseline and 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 outcomes

  1. 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:

    • 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).

  2. 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:

    • Total score,
    • Laxness (permissive, inconsistent discipline);
    • Over-reactivity (harsh, emotional, authoritarian discipline and irritability); and
    • Verbosity/Hostility (use of verbal or physical force).

  3. 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.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2014
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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