Study Results
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Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-11-27
2027-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching
I-InTERACT Parenting Intervention (I2P) and coaching sessions
Online learning sessions for parents of preterm children
I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching
I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions
Online microlearning sessions for parents of preterm children
Internet Resource Group
Control condition
Internet Resources
control condition
Interventions
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I-InTERACT Parenting Intervention (I2P) and coaching sessions
Online learning sessions for parents of preterm children
I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions
Online microlearning sessions for parents of preterm children
Internet Resources
control condition
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
8 Years
ALL
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Shari Wade, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2024-0349
Identifier Type: -
Identifier Source: org_study_id
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