Smart Parents--Safe and Healthy Kids (SPSHK)

April 24, 2020 updated by: Katelyn Guastaferro, Penn State University

Smart Parents--Safe and Healthy Kids: Small RCT

The purpose of the proposed study is to assess the effectiveness of the addition of a single-session child sexual abuse (CSA) prevention module (Smart Parents - Safe and Healthy Kids) on improving parents' knowledge, attitudes, and behaviors regarding CSA prevention for parents already receiving parent-education services. The investigators hypothesize that parents who receive the parenting curriculum and the CSA prevention module will (a) demonstrate significant improvement in CSA-related awareness (i.e., knowledge, attitudes) and protective behaviors from pre-test to post-test, and (b) demonstrate higher scores on CSA-related awareness and protective behaviors as compared to parents who only receive the parenting curriculum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bradford, Pennsylvania, United States, 16701
        • Guidance Resource Center Bradford
      • DuBois, Pennsylvania, United States, 15801
        • Guidance Resource Center DuBois
      • Greensburg, Pennsylvania, United States, 15601
        • Wesley Family Services
      • Nanticoke, Pennsylvania, United States, 18634
        • Greater Nanticoke Area Family Center
      • State College, Pennsylvania, United States, 16803
        • Youth Service Bureau
      • Sunbury, Pennsylvania, United States, 17801
        • Greater Susquehanna Valley United Way

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Parent or caregiver > 18 years old
  2. Parent or caregiver of at least one child under 13
  3. Enrolled in PAT

Exclusion Criteria:

  1. Parent/caregiver does not speak English
  2. Parent is mandated (i.e., court-ordered) to attend parent-training program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PAT-AU
Parents randomized to this arm (i.e., group) receive Parents as Teachers (PAT) services as usual (AU).
Behavioral: Parents as Teachers
Parents as Teachers (PAT) is a parent-support program delivered to parents of children under five and focuses on improving parenting skills through parent-child interactions, development centered parenting, and general well-being. PAT has demonstrated positive effects on child and parent outcomes related to school readiness.
EXPERIMENTAL: PAT+CSA
Parents randomized to this arm (i.e., group) receive the added CSA-focused session (Smart Parents - Safe and Healthy Kids) added to typical Parents as Teachers (PAT).
Behavioral: Smart Parents - Safe and Healthy Kids
Smart Parents - Safe and Healthy Kids (SPHSK) is a module designed to be added to existing evidence-based parent education programs. Because the module builds off of the core parenting skills developed in existing parent education programs, the module can be delivered in one session. SPSHK is comprised of three key CSA-prevention components: healthy child sexual development, parent-child communication about sex and sexual behaviors, and CSA-specific safety strategies such as vetting a babysitter and monitoring one-on-one time with adults. Behaviorally based, the module presents developmentally comprehensive information to parents of children 0-13 and utilizes role-playing scenarios and activities to maximize parents' use of learned skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SmartParents' Knowledge (ASK): Awareness Factor
Time Frame: through study completion, an average of 14 weeks
This factor measures change in parents' self-reported knowledge of CSA and positive attitudes toward CSA prevention, operationally defined henceforth as 'awareness'
through study completion, an average of 14 weeks
Change in SmartParents' Knowledge (ASK): Protective Behaviors Factor
Time Frame: through study completion, an average of 14 weeks
This factor measures change in parents' self-reported use of protective behaviors to limit risk for CSA.
through study completion, an average of 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alabama Parenting Questionnaire: Involvement
Time Frame: through study completion, an average of 14 weeks
e.g., "You ask your child about his/her day in school"
through study completion, an average of 14 weeks
Change in Alabama Parenting Questionnaire: Positive Parenting
Time Frame: through study completion, an average of 14 weeks
e.g., "You hug or kiss your child when he/she does something well"
through study completion, an average of 14 weeks
Change in Alabama Parenting Questionnaire: Inconsistent Discipline
Time Frame: through study completion, an average of 14 weeks
e.g., "The punishment you give your child depends on your mood"
through study completion, an average of 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 2, 2018

Primary Completion (ACTUAL)

November 8, 2019

Study Completion (ACTUAL)

November 8, 2019

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (ACTUAL)

April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMSN 8875

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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