Child Sexual AbuseSPSHKNCT04366687
Smart Parents--Safe and Healthy Kids
A study testing Smart Parents - Safe and Healthy Kids and Parents as Teachers in people with Child Sexual Abuse, run by Penn State University at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Sexual Abuse
- What is being tested?
- Smart Parents - Safe and Healthy Kids and Parents as Teachers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Apr 2018to 8 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent or caregiver > 18 years old
- Parent or caregiver of at least one child under 13
- Enrolled in PAT
Who cannot join
- Parent/caregiver does not speak English
- Parent is mandated (i.e., court-ordered) to attend parent-training program
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Guidance Resource Center Bradford
Bradford, Pennsylvania, 16701
Guidance Resource Center DuBois
DuBois, Pennsylvania, 15801
Wesley Family Services
Greensburg, Pennsylvania, 15601
Greater Nanticoke Area Family Center
Nanticoke, Pennsylvania, 18634
Youth Service Bureau
State College, Pennsylvania, 16803
Greater Susquehanna Valley United Way
Sunbury, Pennsylvania, 17801
About this study
Official title: 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.
- Conditions
- Child Sexual Abuse
- Being tested
- Smart Parents - Safe and Healthy Kids, Parents as Teachers
- Keywords
- child sexual abuse, prevention, parenting, intervention science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Parents - Safe and Healthy KidsBehavioural
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.
Parents as TeachersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PAT-AU | Active comparator | Parents randomized to this arm (i.e., group) receive Parents as Teachers (PAT) services as usual (AU). Receives: 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). Receives: Behavioral: Smart Parents - Safe and Healthy Kids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 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.
Measured: through study completion, an average of 14 weeks
Secondary outcomes (3)
Change in Alabama Parenting Questionnaire: Involvement
e.g., "You ask your child about his/her day in school"
Measured: through study completion, an average of 14 weeks
Change in Alabama Parenting Questionnaire: Positive Parenting
e.g., "You hug or kiss your child when he/she does something well"
Measured: through study completion, an average of 14 weeks
Change in Alabama Parenting Questionnaire: Inconsistent Discipline
e.g., "The punishment you give your child depends on your mood"
Measured: through study completion, an average of 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start2 Apr 2018
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Sexual AbuseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katelyn Guastaferro, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366687
- Sponsor's protocol ID
- CMSN 8875
- Acronym
- SPSHK
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31662600
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Parents--Safe and Healthy Kids: Small RCT
- ClinicalTrials.gov ID
- NCT04366687
- Acronym / sponsor ID
- SPSHK / CMSN 8875
- Conditions
- Child Sexual Abuse
- Keywords
- child sexual abuse, prevention, parenting, intervention science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAT-AU | Active comparator | Behavioral: Parents as TeachersParents randomized to this arm (i.e., group) receive Parents as Teachers (PAT) services as usual (AU). |
| PAT+CSA | Experimental | Behavioral: Smart Parents - Safe and Healthy KidsParents 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent or caregiver > 18 years old
- Parent or caregiver of at least one child under 13
- Enrolled in PAT
Key exclusion criteria (2 listed)
- Parent/caregiver does not speak English
- Parent is mandated (i.e., court-ordered) to attend parent-training program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Parents - Safe and Healthy KidsSmart 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. | Behavioural | PAT+CSA |
| Parents as TeachersParents 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. | Behavioural | PAT-AU |
Primary outcome
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'
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.
3 secondary outcomes
Change in Alabama Parenting Questionnaire: Involvement
Time frame: 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
Change in Alabama Parenting Questionnaire: Inconsistent Discipline
Time frame: through study completion, an average of 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Background: PubMed 31662600Guastaferro 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.
Related trials for Child Sexual Abuse
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
Sex Trafficking, Sex Crimes
Active, not recruiting
Implementation Study With Embedded RCT of a Digital System of Parenting Support Within Government Services in South Africa
Program Effectiveness, Program Implementation
RecruitingObservational study
Young Girls' Experiences of Exposure to Pornography: A Qualitative Study
Exposure to Pornography
Recruiting
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.
Partner
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Parents - Safe and Healthy Kids and Parents as Teachers in people with Child Sexual Abuse, run by Penn State University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SmartParents' Knowledge (ASK): Awareness Factor (time frame: through study completion, an average of 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.