Primary Care Stepping Stones Triple P for Children With Autism

Saint Louis University (SLU)

Status: Completed

Conditions: Autism

Treatments: Other: Treatment as Usual; Behavioral: Primary Care Stepping Stones Triple P (PC-SS Triple P)

Study type: Interventional

Funder types: Other

Identifiers

NCT02236650

SLUBM_24272

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Primary Care Stepping Stones Triple P

Experimental group

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.

Treatment:

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

Wait List Control (WLC)

Active Comparator group

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.

Treatment:

Other: Treatment as Usual