I-InTERACT Preterm Parenting Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- I-InTERACT Parenting Intervention (I2P) and coaching sessions
- Conditions
- Child Behavior Problem
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
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.
Arms & Interventions
I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching
Intervention: I-InTERACT Parenting Intervention (I2P) and coaching sessions
I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching
Intervention: I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions
Internet Resource Group
Control condition
Intervention: Internet Resources
Outcomes
Primary Outcomes
Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score
Time Frame: 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
Time Frame: 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 Outcomes
- ECBI Intensity T-Score(3 months post baseline and 6 months post baseline)
- ECBI Problem T-Score(3 months post baseline and 6 months post baseline)
- Caregiver Psychological Distress(3 months post baseline and 6 months post baseline)