NCT06809153

Brief Summary

Intervention efficacy will be evaluated via a randomized controlled trial in Indiana over 17 weeks with 250 dyads (i.e., divorcing/divorced/separated parents). Dyads will be randomized to business as usual (BAU) or BAU+PCF. Compared to BAU, BAU+PCF will (a) increase parental self-efficacy, (b) decrease parental stress, (c) increase parental knowledge, (d) increase parental motivation to engage with the intervention, (f) increase the quality of parent-child relationships, and (g) improve parent-reported child stress and prosocial behaviors. Parents with higher levels of conflict will be more responsive to parallel parenting, and increased parallel parenting among HIC dyads will lead to reductions in child adjustment problems.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
8mo left

Started Mar 2026

Shorter than P25 for phase_2

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Jan 2027

First Submitted

Initial submission to the registry

January 22, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

January 22, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

Online App

Outcome Measures

Primary Outcomes (7)

  • Parenting Practices

    Parenting practices will be assessed using the Parenting Practices Inventory, a 72-item survey using a 4-point Likert-type scale with rating from 1 to 4 and higher scores indicating more use of the practice, thus higher scores are better outcomes. The subscales have demonstrated adequate internal reliability (alphas = .54 to .80) and have been used in multiple studies to evaluate parenting interventions

    Baseline and 15 weeks

  • Parenting efficacy

    Parenting efficacy will be assessed using four, 6-item subscales from the Tool for Measuring Parent Self-Efficacy, measuring domains of play and enjoyment, discipline practices, perceived control in parenting, and acceptance of parenting role (internal consistency alphas = .80 to .89). Scores range from 1 "agree a lot" to 3 "don't know", with scores on the subscales ranging from 6 to 18 and higher scores indicating less self-efficacy, a worse outcome.

    Baseline and 15 weeks

  • Parenting stress

    Parenting stress will be assessed using the Parenting Stress Scale, which is a brief 18-item Likert-type scale that includes four domains: parental rewards, parental stressors, lack of control, and parental satisfaction. Each item is on a 5-point scale ranging from 1 "Strongly Disagree" to 5 "Strongly Agree". The total scale (after reverse coding half the items) results in possible scores ranging from 18 to 90 with higher scores indicating more parenting stress. The scale has demonstrated good internal reliability (alphas = .86 to .88). This instrument is commonly used for both clinical and non-clinical samples.

    Baseline and 15 weeks

  • Interparental conflict

    The Divorce Conflict Scale is a 6-item screener specifically addressing conflict and cooperation post-relationship/marital dissolution with good internal reliability (alpha reliability = .88). One item uses a 6 point scale ranging from 1 "all of the time" to 6 "at no time"; one item uses a 5-point scale ranging from 1 "very low level of conflict" to 5 "very high level of conflict"; the other 4 items use a 4-point Likert scale ranging from 1 "Strongly Agree" to 4 "Strongly Disagree". The total score ranges from 6 to 27, with higher scores indicating more conflict (worse outcome).

    Baseline and 15 weeks

  • Motivation to engage with the PCF

    Motivation to engage with the Putting Children First training materials will be assessed using the Situational Motivation Scale. This is a 16-item Likert-type scale with four internally consistent factors (internal consistency alphas \> .77): intrinsic motivation, identified regulation, external regulation, and motivation. It uses a 7-point Likert Scale ranging from 1 "does not correspond at all" to 7 "corresponds exactly". The averages for each subscale are calculated with higher scores indicating higher motivation (positive outcome). This measure has been used extensively to evaluate motivation in many contexts and towards many activities, including mandated training.

    Baseline and 15 weeks

  • Child behavior - Strengths and Difficulties Questionnaire

    Parent reports of child behavior will be assessed using the Strengths and Difficulties Questionnaire a brief behavior rating scale for 3- to 16-year-olds that assesses functioning in five domains, each with five items: emotional symptoms (alpha = .80), conduct problems (alpha = .77), hyperactivity (inattention, alpha = .90), peer problems (alpha = .63), and prosocial behavior (alpha =.83).Internal consistency alpha estimates were based on Low et al. The Strengths and Difficulties Questionnaire uses a 3-point scale ranging from 0 "Not True" to 2 "Certainly True". Totals for each subscale are calculated, with higher scores on prosocial behaviors indicating a positive outcome and higher scores on the other four indicating negative outcomes.

    Baseline and 15 weeks

  • Child Behavior - Eyberg Child Behavior Inventory

    The Eyberg Child Behavior Inventory is a 36-item scale completed by parents about their children's behavior (ages 2-16 years) at home using a 7-point Intensity scale and a yes-or-no Problem scale. It identifies conduct problems such as noncompliance, defiance, aggressiveness, and impulsiveness. The Intensity and Problem scales demonstrate good psychometrics, with high internal consistency (both scales alpha = .98), significant test-retest reliability. The subscale averages range from 1 to 7, with higher scores indicating higher levels of negative child behavior.

    Baseline and 15 weeks

Study Arms (2)

Putting Children First

EXPERIMENTAL

Participants will be given access to the PCF app for 15 weeks.

Behavioral: Putting Children First

Control - Business as Usual

NO INTERVENTION

Business as usual control participants will not be directed to any additional parenting trainings.

Interventions

An online parenting intervention for families experiencing high inter-parental conflict during divorce or separation. Children in these families are at greater risk of adverse health outcomes such as mental illness, substance use, and social adjustment problems. Putting Children First will include evidence-based parent training and employ motivational interviewing to increase engagement, will promote parallel parenting to help parents minimize conflict, thereby mitigating negative health outcomes in their children.

Putting Children First

Eligibility Criteria

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

You may qualify if:

  • parents who have recently experienced (within the past 2 years) divorce or separation, or are currently divorcing or separating.
  • have children aged 4-12.
  • Dyadic recruitment (both parents).
  • identified by the court system as experiencing HIC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Jordan Pennefather, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm design comparing the new intervention (PCF) to a business-as-usual control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 5, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

We will provide de-identified data for additional analysis to any qualified individual in the scientific community.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After the final report of the grant is submitted and associated publications are accepted we will make the de-identified final research data and associated codebooks available within 6 months.