NCT04059185

Brief Summary

Universal and broad selective parenting education programs that improve parenting skills, increase parents' understanding of child development, and teach positive child discipline strategies can prevent use of corporal punishment and child physical maltreatment. The proposed research addresses this critical need by investigating brief, relatively low-resource intensive primary prevention parenting programs that can be disseminated widely. By reducing cumulative adverse childhood experiences, which include child physical maltreatment, these interventions are expected to reduce long-term health disparities and risks for major public health problems, such as violence, smoking, obesity, drug abuse, risky sexual behavior, mental health disorders, and heart disease, among others

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,133

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

November 5, 2014

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2022

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

September 1, 2024

Enrollment Period

8 years

First QC Date

July 31, 2019

Results QC Date

June 13, 2024

Last Update Submit

November 27, 2024

Conditions

Keywords

Child abuseChild maltreatment

Outcome Measures

Primary Outcomes (2)

  • Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up

    The measure was collected at baseline, 3 month post-intervention, and 4 year post-intervention. This question asks participants "How often on average in the past month have you spanked your child?" with seven categories: 0) never, 1) once or twice in the past month, 2) about once a week, 3) about twice a week, 4) about once every other day, 5) about once a day, and 6) more than once a day. Using the 0-6 score response range, the outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates decrease in frequency of spanking at the post-intervention timepoint.

    Baseline, 3 months post-intervention, 4 years post-intervention

  • Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up

    The Attitudes Towards Spanking (ATS) scale was collected at baseline, 3 months post-intervention, and 4 years post-intervention. The scale score response range was 0-28, with a higher number being stronger support for spanking. This change outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates a decrease in approval of spanking at the post-intervention time point.

    Baseline, 3 months post-intervention, 4 years post-intervention

Secondary Outcomes (25)

  • Parent - Child Discipline Practices

    Baseline, 3 months post-intervention, 4 years post-intervention

  • Child - Behavioral and Emotional Adjustment

    Baseline, 3 months post-intervention, 4 years post-intervention

  • Child - Externalizing, Internalizing, and Total Symptoms

    4 years post-intervention

  • Parent Sensitivity

    4 years post-intervention

  • Child Social Involvement

    4 years post-intervention

  • +20 more secondary outcomes

Study Arms (3)

Program 1

EXPERIMENTAL

Triple P-Level 2 (TPL2), parenting education and consultation

Other: Triple P-Level 2

Program 2

EXPERIMENTAL

Play Nicely (PN), multimedia, computer-based parenting education

Other: Play Nicely

Control

PLACEBO COMPARATOR

Our "usual care" control group participants receive a resource and referral list for local social services

Other: Usual care

Interventions

Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice.

Program 1

Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes.

Program 2

Our "usual care" control group participants receive a resource and referral list for local social services

Control

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult participants must be:
  • Women
  • English-speaking
  • adults, age 18 or older
  • a parent of at least one child between 2 and 7 years of age
  • a primary caregiver of that child
  • able to return to WIC (or recruitment site) for follow-up 3 months later
  • available for up to 2 hours on date of recruitment to complete the baseline visit
  • Child participants:
  • must be the "index child" of the adult participant as indicated in the baseline interview
  • all genders eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane University School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Catherine Taylor, PhD, LCSW, MPH
Organization
Boston College School of Social Work

Study Officials

  • Catherine A Taylor, PhD

    Boston College School of Social Work

    PRINCIPAL INVESTIGATOR
  • Julia M Fleckman, PhD

    Tulane University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 16, 2019

Study Start

November 5, 2014

Primary Completion

November 21, 2022

Study Completion

November 21, 2022

Last Updated

December 20, 2024

Results First Posted

December 20, 2024

Record last verified: 2024-09

Locations