PAT + Smart Parents for Preventing Child Sexual Abuse

Recruiting at 1 trial location

Overseen By Kate Guastaferro, PhD, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Not in PAT, Language, Child age, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called "Smart Parents" to determine if it helps parents better protect their children from sexual abuse. It compares parents using the standard "Parents as Teachers" (PAT) program with those receiving the additional "Smart Parents" module. The trial aims to discover if the new program increases awareness and protective actions, and if these improvements persist for up to two years. Parents new to the PAT program, who speak English or Spanish, and have a child over one year old may be suitable participants. As an unphased trial, this study offers parents a unique opportunity to contribute to important research that could enhance child safety and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for parents and children?

Research shows that the "Parents as Teachers" (PAT) program, combined with the "Smart Parents" module, receives positive feedback from families. Studies have found that families in the PAT program maintain safer homes and report fewer cases of child abuse, with a 22% lower chance of confirmed child abuse in these families.

The Smart Parents module helps parents understand normal sexual development and communicate about it effectively. It raises parents' awareness and encourages protective actions without causing major issues. These findings suggest that combining PAT and Smart Parents is both safe and beneficial for families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PAT + Smart Parents approach because it adds an innovative educational module to the existing Parents as Teachers (PAT) program, specifically targeting the prevention of child sexual abuse. Unlike standard approaches that primarily focus on general parenting skills, this method combines the proven benefits of PAT with an additional focus on empowering parents with specific strategies to protect their children from sexual abuse. This dual approach aims to enhance parental awareness and proactive involvement, potentially leading to more effective prevention outcomes.

What evidence suggests that this trial's treatments could be effective for preventing child sexual abuse?

Research has shown that the Parents as Teachers (PAT) program helps families make their homes safer and reduces child abuse, with a 22% lower chance of confirmed reports. In this trial, one group of participants will receive the Smart Parents module in addition to PAT. The Smart Parents module helps parents understand their children's sexual development and improve communication. Early results suggest that this module aids parents in recognizing and preventing child sexual abuse (CSA). Studies have demonstrated that programs like Smart Parents can be successfully implemented and help families create safer environments for children. Combining PAT with Smart Parents could enhance parents' protective actions and awareness of CSA-related issues. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for new parents enrolled in the Parents as Teachers (PAT) program who speak English or Spanish and have at least one child over 12 months old at home. It's not open to those previously involved with PAT foundational sessions, not enrolled in PAT, or without a child over 12 months.

Inclusion Criteria

One parent per household that is currently enrolled in Parents as Teachers (PAT) qualified to receive bi-weekly visits

I have a child over 12 months old living with me.

Only newly enrolled parents (i.e., parents who have not received the PAT foundational sessions)

Exclusion Criteria

Not currently enrolled in Parents as Teachers (PAT)

Previously enrolled in Parents as Teachers (PAT) (i.e., parents who have received the PAT foundational sessions)

I do not have a child older than 12 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Smart Parents module in addition to the Parents as Teachers program

Varies by cluster

Ongoing participation in PAT sessions

Follow-up

Participants are monitored for retention of awareness and use of protective behaviors

24 months

Assessments at 12 and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Parents as Teachers (PAT)
• Smart Parents

Trial Overview The study tests if adding Smart Parents—a program focused on preventing child sexual abuse—to the regular PAT curriculum improves parental awareness and protective actions against CSA. The trial also looks at how well these improvements hold up after one and two years.

How Is the Trial Designed?

Group I: PAT + Smart Parents Experimental Treatment 1 Intervention

Participants in this arm will receive the additional Smart Parents module, added to Parents as Teachers (PAT) in which they are already enrolled. This is the experimental condition.

Group II: PAT as usual Active Control 1 Intervention

Participants in this arm will continue to receive Parents as Teachers (PAT) as usual. This is the treatment as usual condition (comparison).

Parents as Teachers (PAT) is already approved in United States for the following indications:

Approved in United States as Parents as Teachers for:

• Parent education
• Child development support

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Published Research Related to This Trial

A study involving 61 low-income preschool children found that both parents and teachers were equally effective in teaching personal safety skills, with children showing significant knowledge gains about sexual abuse compared to a control group.

The effectiveness of the programs was maintained over two months, and there were no reported increases in negative behaviors or heightened fear among children, indicating that these personal safety programs can be safely implemented at home and in school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of teachers vs. parents as instructors of a personal safety program for preschoolers. Wurtele, SK., Gillispie, EI., Currier, LL., et al.[2019]

The Smart Parents-Safe and Healthy Kids (SPSHK) program, when added to the existing Parents as Teachers (PAT) program, significantly increased parents' awareness of child sexual abuse (CSA) and their use of protective behaviors, with these improvements maintained at a one-month follow-up.

Importantly, the addition of SPSHK did not detract from the effectiveness of the original PAT program, indicating that it can be successfully integrated into existing parent training without compromising its core objectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Focused Sexual Abuse Prevention: Results From a Cluster Randomized Trial. Guastaferro, K., Felt, JM., Font, SA., et al.[2023]

A study involving primary school-aged children (7-13 years) showed that safety education programs for both children and parents can significantly reduce accidental injuries over time, with a notable decrease in the second year after intervention.

In the second year, the Intervention group had a lower incidence of accidental injuries (6.54%) compared to the Control group (8.63%), indicating that the education had a lasting impact on injury prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interventions to prevent accidental injuries in children between 7 and 13 years of age]. Zhao, CH., Qiu, HS., Qiu, HX.[2006]

Parents who participated in an individualized, three-part safety education program recognized more home hazards (9.4 vs. 8.4) compared to those who received standard education, indicating improved safety knowledge.

The intervention group also had a lower mean hazard score (2.4 vs. 3.0) in their homes, suggesting that the tailored safety education led to better safety practices, although reported accidents were similar between both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety education in a pediatric primary care setting. Kelly, B., Sein, C., McCarthy, PL.[2007]

The 'parent education package' (PEP) was well-received by parents but did not lead to any significant changes in children's behavior, indicating a lack of efficacy in preventing behavior problems.

The study suggests that future prevention programs might be more effective if they focus on promoting positive perceptions of children among parents rather than just providing educational materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent education in preventing behaviour problems. Hewitt, K.[2004]

Child sexual abuse prevention programs, primarily focused on group-based instruction for children, have shown that while children can learn about personal safety, this knowledge does not always translate into sustained behavioral changes.

Programs that incorporate role playing and participant modeling may enhance the effectiveness of these educational efforts, particularly for children aged 7 to 12, and can lead to increased disclosures of abuse, although there are concerns about potential fear and anxiety induced by such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of child sexual abuse. Daro, DA.[2016]

The parent training (PT) technique, implemented by child specialists over a 2-4 year period, successfully resolved behavioral abnormalities in 7 out of 12 children with a history of maltreatment, highlighting its efficacy in fostering secure attachments.

The intervention was particularly effective for children who had not yet started elementary school, suggesting that early detection and intervention are crucial for addressing behavioral issues stemming from maltreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team-based parent training by child specialists helps maltreated children. Yokoyama, H., Tomizawa, Y., Sato, Y., et al.[2019]

The Parents as Teachers (PAT) program showed small overall positive effects on parent knowledge and behavior, but no significant gains in child development or health across the entire study population of two randomized trials.

However, specific subgroups, such as primarily Spanish-speaking Latino families in the Salinas Valley, experienced significant developmental benefits, with children gaining about one month of developmental advantage for every 10 home visits received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Parents as Teachers program: results from two demonstrations. Wagner, MM., Clayton, SL.[2019]

In a study analyzing pediatric hospitalizations, 24 patients experienced 29 adverse events (AEs) related to medical care, with a rate of 3.61% across all pediatric hospitalizations, which is lower than the 6.4% rate seen in non-elderly adults.

A significant 65.5% of these adverse events were deemed preventable, highlighting the need for targeted prevention strategies, especially since medication-related events accounted for 37.9% of the incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. Requena, J., Miralles, JJ., Mollar, J., et al.[2012]

A Spanish-speaking mother received home training through Project SafeCare, which included child health care, planned activities, and home safety training, resulting in her meeting all training criteria.

After the training, the mother observed a decrease in negative interactions between her oldest child and parents, and these improvements were maintained over time, indicating the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Spanish protocols for teaching bonding, home safety, and health care skills to a mother reported for child abuse. Cordon, IM., Lutzker, JR., Bigelow, KM., et al.[2019]

The HEALTH intervention, part of the Parents as Teachers program, did not significantly change preschool children's BMI or maternal feeding practices compared to usual care, despite showing some improvements in specific feeding practices over time.

However, combined analyses indicated a decrease in children's BMI percentile, suggesting that while the intervention may not have had a broad impact, it could still contribute to better weight management in some areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Healthy Weight Intervention Embedded in a Home-Visiting Program on Children's Weight and Mothers' Feeding Practices. Morshed, AB., Tabak, RG., Schwarz, CD., et al.[2023]

A family-based reporting system for adverse events in pediatric inpatients did not significantly increase the reporting rates by healthcare providers, indicating a disconnect between family and staff perceptions of safety events.

Out of 321 events reported by families, 48% were legitimate safety concerns, highlighting that families can provide valuable insights into patient safety that are often overlooked by healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. Daniels, JP., Hunc, K., Cochrane, DD., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04366687

NCT04366687 | Smart Parents--Safe and Healthy Kids 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 ...

2. parentsasteachers.org parentsasteachers.org/research-and-results/

Research and Results Parents as Teachers families practice better home safety, have fewer maltreatment reports, a 22% lower likelihood of substantiated child maltreatment, reduced ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6818652/

A Parent-focused Child Sexual Abuse Prevention Program The Smart Parents – Safe and Healthy Kids module is designed to help parents (a) learn about typical sexual development; (b) know how to talk ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04366687?term=AREA%5BBasicSearch%5D(as%20child)&rank=5

NCT04366687 | Smart Parents--Safe and Healthy Kids 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8024425/

Parent-Focused Sexual Abuse Prevention This study tested whether a child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK), could be implemented as an additional ...

6. hhd.psu.edu hhd.psu.edu/SafeHealthyChildren/Research/Sexual-Abuse-Prevention/Smarter-Parents-Safer-Kids

Smarter Parents, Safer Kids Read more about the development of Smarter Parents, Safer Kids and the demonstrated effect of the program on parental awareness and use of protective behaviors.

7. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/1077559520963870

Parent-Focused Sexual Abuse Prevention This study tested whether a child sexual abuse (CSA) prevention program, Smart Parents–Safe and Healthy Kids (SPSHK), could be implemented ...