| NCT ID | NCT06767293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Child Behavior Problem |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-11-27 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-11-27 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.
Eligibility Criteria
Inclusion Criteria: * Born at \< 32 weeks gestational age. * Total T score of \> 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of \> 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale. * English is the primary spoken language in the home. Exclusion Criteria: * Is not 18 years or older. * Participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings). * English is not the primary language spoken in the home. * Caregivers with a psychiatric hospitalization in the past year.
Contact & Investigator
Shari Wade, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT06767293 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 8 Years, studying Child Behavior Problem. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06767293 currently recruiting?
Yes, NCT06767293 is actively recruiting participants. Contact the research team at shari.wade@cchmc.org for enrollment information.
Where is the NCT06767293 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06767293 clinical trial?
NCT06767293 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Shari Wade, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 90 participants.