Clinical trial NCT02236650: Primary Care Stepping Stones Triple P for Children With Autism
Official title: A Pilot Study of Primary Care Stepping Stones Triple P for Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Parental Resilience
Parental Stress
Family Adaptation
Autistic Disorder
Behavior
Child Behavior
Child Development Disorders
Pervasive Developmental Disabilities
Caregivers
Parents
Parenting
Primary Health Care
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from Baseline in Connor-Davidson Resilience Scale Score at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from Baseline in Parent Stress Index - Short Form Score at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from Baseline in Family Assessment Device score at 4 weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change from Baseline in Aberrant Behavior Checklist Score at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from Baseline in The Parenting Scale Score at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from Baseline in the Parenting Sense of Competence Scale Score at 4 weeks
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Saint Louis University, Knights of Columbus Developmental Center
state: Missouri
Study officials:
affiliation: Saint Louis University School of Medicine, Department of Pediatrics, Division of Developmental Pediatrics
name: Debra H. Zand, PhD
role: PRINCIPAL_INVESTIGATOR
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