Primary Care Stepping Stones Triple P for Children With Autism

NCT02236650 | Completed

• 1 other identifier: SLUBM_24272
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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: 1. Parental Distress, 2. Parent-Child Dysfunctional Interaction, 3. Difficult Child, and 4. Total Stress.

  Baseline and 4 weeks

• Change from Baseline in Family Assessment Device score at 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).

  Baseline and 4 weeks

Secondary Outcomes (3)

• Change from Baseline in Aberrant Behavior Checklist Score at 4 weeks

  Baseline and 4 weeks

• Change from Baseline in The Parenting Scale Score at 4 weeks

  Baseline and 4 weeks

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

  Baseline and 4 weeks

Study Arms (2)

Primary Care Stepping Stones Triple P

EXPERIMENTAL

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.

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

Wait List Control (WLC)

ACTIVE COMPARATOR

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.

Other: Treatment as Usual

Interventions

Primary Care Stepping Stones Triple P (PC-SS Triple P) BEHAVIORAL

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.

Also known as: Postive Parenting Program, Triple P, Stepping Stones Triple P, Stepping Stones Positive Parenting Program

Primary Care Stepping Stones Triple P

Treatment as Usual OTHER

Treatment as Usual for 4 weeks

Also known as: Service as Usual

Wait List Control (WLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being at least 18 years of age
• 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).

You may not qualify if:

• inability to provide informed consent.
• being non-English speaking.
• being a ward of the State of Missouri.
• being a sibling of another study participant.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University, Knights of Columbus Developmental Center

St Louis, Missouri, 63110, United States

Location

Related Publications (40)

• Turner K, Markie-Dadds C, Sanders M. Practitioner's manual for primary care tripleP. Brisbane, QLD, Australia: Triple P International Pty. Ltd.; 2010.

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Related Links

• Family Research Collaborative - Autism \& Parenting Resilience

MeSH Terms

Conditions

Autistic Disorder; Behavior; Child Behavior; Developmental Disabilities

Interventions

(tris(diphenylphosphinomethyl)phenylborate)(p-tolylnitrido)iron(I); Therapeutics

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Debra H. Zand, PhD

  Saint Louis University School of Medicine, Department of Pediatrics, Division of Developmental Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

US (1)