Skip to content

Primary Care Stepping Stones Triple P for Children With Autism

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02236650
Enrollment
26
Registered
2014-09-10
Start date
2014-07-31
Completion date
2015-12-31
Last updated
2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALPrimary 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.

OTHERTreatment as Usual

Treatment as Usual for 4 weeks

Sponsors

St. Louis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeksBaseline and 4 weeksMeasure 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 weeksGeneral scale of resilience in adult populations with a bias towards coping with stress and adversity.
Change from Baseline in Parent Stress Index - Short Form Score at 4 weeksBaseline and 4 weeksSources 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 weeksAssesses 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).

Secondary

MeasureTime frameDescription
Change from Baseline in The Parenting Scale Score at 4 weeksBaseline and 4 weeksMeasures 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 weeksMeasures parents' sense of confidence and satisfaction with their parenting and their self-efficacy in the parenting role.
Change from Baseline in Aberrant Behavior Checklist Score at 4 weeksBaseline and 4 weeksAssesses 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026