Parenting BehaviorPhase 2PCFNCT06809153
Putting Children First - Parent Training for Parents in High Conflict
A Phase 2 study testing Putting Children First in people with Parenting Behavior and Parent Management Training, run by IRIS Media Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting Behavior, Parent Management Training, Parent-Child Relations
- What is being tested?
- Putting Children First
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Promoting Parallel Parenting: Putting Children First During High-Conflict Divorce and Separation (PCF)
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.
Read the detailed description
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. Given Indiana rules requiring parent education among divorcing and separating parents (i.e., BAU), the investigators expect nearly all divorcing parents to complete some form of parent education. Thus, the investigators will collect information from the court system on courses provided, as well as ask participants about the courses they have engaged in and the time spent. This aligns with best practice standards defining the control condition135; 136 and allows for a demonstration of whether PCF has benefits above and beyond existing interventions (BAU). The time spent on trainings will be included in the outcome analyses as a covariate. The trial will include 1 week for pre-test assessments, 9 weeks for PCF training, 6 weeks for reflection/practice, and 1 week for post-test assessments).
Hypotheses. The investigators hypothesize that:
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.
Participants. The sample will consist of parents who have recently experienced (within the past 2 years) divorce or separation, or are currently divorcing or separating, and who have children aged 4-12. Parents will be referred to the PCF intervention from family courts in Indiana (see Letters of Support) as they are identified by the court system as experiencing HIC. To approximate the real world and ensure that the sample is representative, family court judges, who would likely mandate completion of this intervention, will refer families they deem "high conflict." To be eligible for the study, both parents must consent. Because the stress of divorce and high levels of conflict can be deleterious to mental health and well-being, all participants in the study will be provided with a list of resources for individuals experiencing mental health, substance use, or intimate partner violence in their local area, and will be encouraged to seek assistance if needed. Attrition rates of parenting interventions are often high.137 However, the investigators have instituted practices to enhance retention (e.g., regular reminders, reasonable pacing of the training to 1 module per week, motivational interviewing). From the investigators experience in similar studies, the investigators expect attrition of less than 30%.42; 138 Since the research design requires both members of the dyad to complete the assessments, the investigators define attrition as one parent failing to complete posttest assessments. The investigators plan to recruit 250 dyads (500 parents) to ensure a final sample of at least 175 dyads (see Power Considerations).
- Being tested
- Putting Children First
- Keywords
- Online App
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Putting Children FirstBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Putting Children First | Experimental | Participants will be given access to the PCF app for 15 weeks. Receives: Behavioral: Putting Children First |
| Control - Business as Usual | No intervention | Business as usual control participants will not be directed to any additional parenting trainings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenting BehaviorStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm design comparing the new intervention (PCF) to a business-as-usual control.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRIS Media Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Pennefather, IRIS Media Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809153
- Sponsor's protocol ID
- 1R44HD111084-01A1
- Acronym
- PCF
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide de-identified data for additional analysis to any qualified individual in the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Parallel Parenting: Putting Children First During High-Conflict Divorce and Separation (PCF)
- ClinicalTrials.gov ID
- NCT06809153
- Acronym / sponsor ID
- PCF / 1R44HD111084-01A1
- Keywords
- Online App
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRIS Media IncUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Feb 2025 (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.
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.
Detailed description
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. Given Indiana rules requiring parent education among divorcing and separating parents (i.e., BAU), the investigators expect nearly all divorcing parents to complete some form of parent education. Thus, the investigators will collect information from the court system on courses provided, as well as ask participants about the courses they have engaged in and the time spent. This aligns with best practice standards defining the control condition135; 136 and allows for a demonstration of whether PCF has benefits above and beyond existing interventions (BAU). The time spent on trainings will be included in the outcome analyses as a covariate. The trial will include 1 week for pre-test assessments, 9 weeks for PCF training, 6 weeks for reflection/practice, and 1 week for post-test assessments).
Hypotheses. The investigators hypothesize that:
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.
Participants. The sample will consist of parents who have recently experienced (within the past 2 years) divorce or separation, or are currently divorcing or separating, and who have children aged 4-12. Parents will be referred to the PCF intervention from family courts in Indiana (see Letters of Support) as they are identified by the court system as experiencing HIC. To approximate the real world and ensure that the sample is representative, family court judges, who would likely mandate completion of this intervention, will refer families they deem "high conflict." To be eligible for the study, both parents must consent. Because the stress of divorce and high levels of conflict can be deleterious to mental health and well-being, all participants in the study will be provided with a list of resources for individuals experiencing mental health, substance use, or intimate partner violence in their local area, and will be encouraged to seek assistance if needed. Attrition rates of parenting interventions are often high.137 However, the investigators have instituted practices to enhance retention (e.g., regular reminders, reasonable pacing of the training to 1 module per week, motivational interviewing). From the investigators experience in similar studies, the investigators expect attrition of less than 30%.42; 138 Since the research design requires both members of the dyad to complete the assessments, the investigators define attrition as one parent failing to complete posttest assessments. The investigators plan to recruit 250 dyads (500 parents) to ensure a final sample of at least 175 dyads (see Power Considerations).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm design comparing the new intervention (PCF) to a business-as-usual control.
| Arm | Type | Receives |
|---|---|---|
| Putting Children First | Experimental | Behavioral: Putting Children FirstParticipants will be given access to the PCF app for 15 weeks. |
| Control - Business as Usual | No intervention | –Business as usual control participants will not be directed to any additional parenting trainings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Putting Children FirstAn 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. | Behavioural | Putting Children First |
Primary outcome
Parenting Practices
Time frame: Baseline and 15 weeks
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
Parenting efficacy
Time frame: Baseline and 15 weeks
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.
Parenting stress
Time frame: Baseline and 15 weeks
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.
Interparental conflict
Time frame: Baseline and 15 weeks
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).
Motivation to engage with the PCF
Time frame: Baseline and 15 weeks
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.
Child behavior - Strengths and Difficulties Questionnaire
Time frame: Baseline and 15 weeks
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.
Child Behavior - Eyberg Child Behavior Inventory
Time frame: Baseline and 15 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Yes. We will provide de-identified data for additional analysis to any qualified individual in the scientific community.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Putting Children First in people with Parenting Behavior and Parent Management Training, run by IRIS Media Inc.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Pennefather, PhD (877-874-3642, jordanp@trifoia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Practices (time frame: Baseline and 15 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2025.