Primary Care Stepping Stones Triple P for Children With Autism

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236650
• Other study ID #: SLUBM_24272
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: December 16, 2015
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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:
• Treatment as Usual
Treatment as Usual for 4 weeks

Locations

Country	Name	City	State
United States	Saint Louis University, Knights of Columbus Developmental Center	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Family Research Collaborative - Autism & Parenting Resilience