I-InTERACT Preterm Parenting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: I-InTERACT Parenting Intervention (I2P) and coaching sessions, I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions, Internet Resources.
- Who it may be relevant to
- Registry conditions: Child Behavior Problem, Preterm, Parent-Child Relations, Parenting. Basic parameters: 3 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
I-InTERACT Preterm Parenting Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral I-InTERACT Parenting Intervention (I2P) and coaching sessions
Online learning sessions for parents of preterm children - Behavioral I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions
Online microlearning sessions for parents of preterm children - Other Internet Resources
control condition
Primary outcome measures
- Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score [Time frame: 3 months post baseline and 6 months post baseline]
- Child Behavior Checklist Externalizing T-score [Time frame: 3 months post baseline and 6 months post baseline]
Secondary outcome measures (3)
- ECBI Intensity T-Score [Time frame: 3 months post baseline and 6 months post baseline]
- ECBI Problem T-Score [Time frame: 3 months post baseline and 6 months post baseline]
- Caregiver Psychological Distress [Time frame: 3 months post baseline and 6 months post baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Publications
- Ask H, Gustavson K, Ystrom E, Havdahl KA, Tesli M, Askeland RB, Reichborn-Kjennerud T. Association of Gestational Age at Birth With Symptoms of Attention-Deficit/Hyperactivity Disorder in Children. JAMA Pediatr. 2018 Aug 1;172(8):749-756. doi: 10.1001/jamapediatrics.2018.1315. PMID 29946656
- de Silva A, Neel ML, Maitre N, Busch T, Taylor HG. Resilience and vulnerability in very preterm 4-year-olds. Clin Neuropsychol. 2021 Jul;35(5):904-924. doi: 10.1080/13854046.2020.1817565. Epub 2020 Sep 13. PMID 32924801
- Jones K, Daley D, Hutchings J, Bywater T, Eames C. Efficacy of the Incredible Years Programme as an early intervention for children with conduct problems and ADHD: long-term follow-up. Child Care Health Dev. 2008 May;34(3):380-90. doi: 10.1111/j.1365-2214.2008.00817.x. PMID 18410644
- Williams TS, McDonald KP, Roberts SD, Westmacott R, Dlamini N, Tam EWY. Understanding Early Childhood Resilience Following Neonatal Brain Injury From Parents' Perspectives Using a Mixed-Method Design. J Int Neuropsychol Soc. 2019 Apr;25(4):390-402. doi: 10.1017/S1355617719000079. PMID 31050330
- 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. PMID 32882481
- 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. PMID 30489350
Identifiers
NCT: NCT06767293 · 2024-0349