Clinical trial NCT06809153: Putting Children First - Parent Training for Parents in High Conflict
Official title: Promoting Parallel Parenting: Putting Children First During High-Conflict Divorce and Separation (PCF)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Parenting Behavior
Parent Management Training
Parent-Child Relations
Child Behavior
Keywords: Online App
Lead sponsor: IRIS Media Inc
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm design comparing the new intervention (PCF) to a business-as-usual control.
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

-

Primary outcomes:
measure: Parenting Practices
timeFrame: Baseline and 15 weeks
measure: Parenting efficacy
timeFrame: Baseline and 15 weeks
measure: Parenting stress
timeFrame: Baseline and 15 weeks
measure: Interparental conflict
timeFrame: Baseline and 15 weeks
measure: Motivation to engage with the PCF
timeFrame: Baseline and 15 weeks
measure: Child behavior - Strengths and Difficulties Questionnaire
timeFrame: Baseline and 15 weeks
measure: Child Behavior - Eyberg Child Behavior Inventory
timeFrame: Baseline and 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: