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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings