NCT04366687

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

April 9, 2020

Last Update Submit

April 24, 2020

Conditions

Keywords

child sexual abusepreventionparentingintervention science

Outcome Measures

Primary Outcomes (2)

  • Change in SmartParents' Knowledge (ASK): Awareness Factor

    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

    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 Outcomes (3)

  • Change in Alabama Parenting Questionnaire: Involvement

    through study completion, an average of 14 weeks

  • Change in Alabama Parenting Questionnaire: Positive Parenting

    through study completion, an average of 14 weeks

  • Change in Alabama Parenting Questionnaire: Inconsistent Discipline

    through study completion, an average of 14 weeks

Study Arms (2)

PAT-AU

ACTIVE COMPARATOR

Parents randomized to this arm (i.e., group) receive Parents as Teachers (PAT) services as usual (AU).

Behavioral: Parents as Teachers

PAT+CSA

EXPERIMENTAL

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

Interventions

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.

PAT+CSA

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.

PAT-AU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent or caregiver \> 18 years old
  • Parent or caregiver of at least one child under 13
  • Enrolled in PAT

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Guidance Resource Center Bradford

Bradford, Pennsylvania, 16701, United States

Location

Guidance Resource Center DuBois

DuBois, Pennsylvania, 15801, United States

Location

Wesley Family Services

Greensburg, Pennsylvania, 15601, United States

Location

Greater Nanticoke Area Family Center

Nanticoke, Pennsylvania, 18634, United States

Location

Youth Service Bureau

State College, Pennsylvania, 16803, United States

Location

Greater Susquehanna Valley United Way

Sunbury, Pennsylvania, 17801, United States

Location

Related Publications (1)

  • Guastaferro K, Zadzora KM, Reader JM, Shanley J, Noll JG. A Parent-focused Child Sexual Abuse Prevention Program: Development, Acceptability, and Feasibility. J Child Fam Stud. 2019 Jul;28(7):1862-1877. doi: 10.1007/s10826-019-01410-y. Epub 2019 Apr 18.

    PMID: 31662600BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 29, 2020

Study Start

April 2, 2018

Primary Completion

November 8, 2019

Study Completion

November 8, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations