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

Trial Summary

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 data supports the effectiveness of the treatment Parents as Teachers (PAT) and Smart Parents for preventing child sexual abuse?

Research shows that adding the Smart Parents-Safe and Healthy Kids module to the Parents as Teachers program significantly increases parents' awareness of child sexual abuse and their use of protective behaviors, without affecting the original program's effectiveness. This suggests that the combined treatment can enhance parents' ability to prevent child sexual abuse. ^{1 2 3 4 5}

Is the PAT + Smart Parents program safe for preventing child sexual abuse?

Research suggests that programs involving parents teaching personal safety to preschool children, like PAT + Smart Parents, can be implemented safely without increasing negative behaviors or fear in children. ^{1 6 7 8 9}

How does the PAT + Smart Parents treatment differ from other treatments for preventing child sexual abuse?

The PAT + Smart Parents treatment is unique because it combines the Parents as Teachers program with the Smart Parents-Safe and Healthy Kids module, enhancing parents' awareness and protective behaviors against child sexual abuse without affecting the original program's efficacy. This approach is novel as it integrates child sexual abuse prevention into an existing parent education framework, making it more comprehensive and effective. ^{1 4 10 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to test the effectiveness of a parent-focused child sexual abuse prevention program (Smart Parents) delivered to parents enrolled in a parent education program (Parents as Teachers; PAT). The main questions the trial aims to answer are: 1. Does PAT + Smart Parents improve parents' CSA-related awareness and protective behaviors compared to PAT as usual? 2. Are potential gains maintained 12- and 24-months post intervention? 3. What parent-, provider-, and organizational-level factors hold promise for future dissemination and implementation efforts?

Eligibility Criteria

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)

I do not have a child older than 12 months.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A comparison of teachers vs. parents as instructors of a personal safety program for preschoolers. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating Spanish protocols for teaching bonding, home safety, and health care skills to a mother reported for child abuse. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Prevention of child sexual abuse. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Parent-Focused Sexual Abuse Prevention: Results From a Cluster Randomized Trial. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Team-based parent training by child specialists helps maltreated children. [2019]

6. China pubmed.ncbi.nlm.nih.gov

[Interventions to prevent accidental injuries in children between 7 and 13 years of age]. [2006]

7. Spain pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Safety education in a pediatric primary care setting. [2007]

9. Canada pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. [2022]

10. United States 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The Parents as Teachers program: results from two demonstrations. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Parent education in preventing behaviour problems. [2004]