Clinical trial NCT06767293: I-InTERACT Preterm Parenting
Official title: I-InTERACT Preterm Parenting Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior Problem
Preterm
Parent-Child Relations
Parenting
Keywords: telehealth
online learning
microlearning
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score
timeFrame: 3 months post baseline and 6 months post baseline
measure: Child Behavior Checklist Externalizing T-score
timeFrame: 3 months post baseline and 6 months post baseline
Secondary outcomes:
measure: ECBI Intensity T-Score
timeFrame: 3 months post baseline and 6 months post baseline
measure: ECBI Problem T-Score
timeFrame: 3 months post baseline and 6 months post baseline
measure: Caregiver Psychological Distress
timeFrame: 3 months post baseline and 6 months post baseline
Other outcomes:
measure: Parental Stress
timeFrame: 3 months post baseline and 6 months post baseline
measure: Positive Attitude Towards Child
timeFrame: 3 months post baseline and 6 months post baseline
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Shari Wade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wang C, Bakhet M, Roberts D, Gnani S, El-Osta A. The efficacy of microlearning in improving self-care capability: a systematic review of the literature. Public Health. 2020 Sep;186:286-296. doi: 10.1016/j.puhe.2020.07.007. Epub 2020 Aug 31.
citation: De Gagne JC, Woodward A, Park HK, Sun H, Yamane SS. Microlearning in health professions education: a scoping review protocol. JBI Database System Rev Implement Rep. 2019 Jun;17(6):1018-1025. doi: 10.11124/JBISRIR-2017-003884.