I-InTERACT Preterm Parenting

Not Applicable

Recruiting

• Conditions: Child Behavior Problem; Preterm; Parenting; Parent-Child Relations

• Registration Number: NCT06767293
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Many children born very preterm or extremely preterm exhibit a distinct behavioral phenotype characterized by impairments in cognition and attention and concomitant social and emotional problems. These children are significantly more likely to develop ADHD than children born at term and have similar rates of comorbid symptoms such as noncompliance, emotionality, and attention-seeking behaviors as those observed in children with ADHD. Although addressing children's mental health and behavioral challenges is a priority identified by parents, evidence-based interventions to promote effective parenting and mitigate child behavior problems in this population are lacking.

From 2021-2022, a single-arm pilot clinical trial was conducted for children born very preterm using content adapted from previous trials of I-InTERACT North and I-InTERACT Express, which included seven sessions and weekly online coaching from a therapist. Children demonstrated a significant reduction in externalizing behavior problems from pre- to post-intervention, and caregivers' positive parenting skills significantly increased during the same period.

Given relatively high rates of attrition in the pilot trial and stakeholder feedback regarding challenges in completing the program, the utility of microlearning delivery-delivering content in approximately 5-minute segments-will be tested relative to the existing I-InTERACT Preterm program and an internet resource comparison group. This approach is anticipated to improve uptake, engagement, and retention, particularly for young adults who routinely consume information in this format, while maintaining the efficacy of the original program.

A three-arm randomized controlled trial (RCT) is proposed to compare the seven-session I2P program to the microlearning delivery mode (I2P-Micro) and an internet resource comparison group (IRC). Participants in the I2P and I2P-Micro groups will also meet weekly or biweekly with a trained therapist to review content and receive coaching while practicing skills. 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.

Study Timeline

• Study First Submitted: 2024-11-12
• Study Start: 2024-11-27
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-09
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-10-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score	3 months post baseline and 6 months post baseline	Minimum score is 0, maximum score is not applicable as parents may exhibit any number of positive behaviors during the time frame data is collected. A higher score means a greater number of positive parenting behaviors were exhibited, which is considered better.
Child Behavior Checklist Externalizing T-score	3 months post baseline and 6 months post baseline	Minimum t score for girls is 33, and maximum t score is 100. Minimum t score for boys is 34 and maximum t score is 100. A higher t score indicates more externalizing behaviors, which is considered worse.

Secondary Outcome Measures

Name	Time	Method
ECBI Intensity T-Score	3 months post baseline and 6 months post baseline	The ECBI Problem T-Score is a 36-item checklist of concerns (e.g., noncompliance, emotionality, attention-seeking) will be used to assess the number and intensity of child behavior problems pre- and post-treatment. On the ECBI, the parent rates how often each behavior occurs (7-point intensity scale), and whether the behavior is a problem (Yes/No Problem Scale). Higher T-Scores indicate greater intensity of problem behaviors. The lowest T-Score is 36 and the highest is 252, with a clinical cut-off at 60. During screening for this study, a T-Score greater than 55 for this scale meets meeting eligibility criteria.
ECBI Problem T-Score	3 months post baseline and 6 months post baseline	The ECBI Problem T-Score is a 36-item checklist of concerns (e.g., noncompliance, emotionality, attention-seeking) will be used to assess the number and intensity of child behavior problems pre- and post-treatment. On the ECBI, the parent rates how often each behavior occurs (7-point intensity scale), and whether the behavior is a problem (Yes/No Problem Scale). Higher T-Scores indicate more challenging behaviors. The lowest T-Score is 41 and the highest is 88, with a clinical cut-off at 60. During screening for this study, a T-Score greater than 55 for this scale meets meeting eligibility criteria.
Caregiver Psychological Distress	3 months post baseline and 6 months post baseline	Caregiver psychological distress will be assessed using the CES-D, a 20-item self-report inventory in which participants rate how often over the last week they have been bothered by various symptoms of depression in the last week. Total scores range from 0 to 60, with higher scores indicate greater caregiver distress. Scores 16 and above indicate a risk for clinical depression.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States