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Primary Care Stepping Stones Triple P for Children With Autism

Not Applicable
Completed
Conditions
Autism
Interventions
Behavioral: Primary Care Stepping Stones Triple P (PC-SS Triple P)
Other: Treatment as Usual
Registration Number
NCT02236650
Lead Sponsor
St. Louis University
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:

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Primary Care Stepping Stones Triple PPrimary Care Stepping Stones Triple P (PC-SS 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.
Wait List Control (WLC)Treatment as UsualWait 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.
Primary Outcome Measures
NameTimeMethod
Change from Baseline in Parent Stress Index - Short Form Score at 4 weeksBaseline 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.

Change from Baseline in Family Assessment Device score at 4 weeksBaseline 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).

Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeksBaseline and 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 weeksBaseline and 4 weeks

General scale of resilience in adult populations with a bias towards coping with stress and adversity.

Secondary Outcome Measures
NameTimeMethod
Change from Baseline in Aberrant Behavior Checklist Score at 4 weeksBaseline 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).

Change from Baseline in The Parenting Scale Score at 4 weeksBaseline 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).

Change from Baseline in the Parenting Sense of Competence Scale Score at 4 weeksBaseline and 4 weeks

Measures parents' sense of confidence and satisfaction with their parenting and their self-efficacy in the parenting role.

Trial Locations

Locations (1)

Saint Louis University, Knights of Columbus Developmental Center

🇺🇸

St. Louis, Missouri, United States

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