I-InTERACT Preterm Parenting

NCT06767293 | Recruiting

• 1 other identifier: 2024-0349
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavior Problem; Parent-Child Relations; Parenting; Preterm

Keywords

telehealth; online learning; microlearning

Outcome Measures

Primary Outcomes (2)

• Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score

  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.

  3 months post baseline and 6 months post baseline

• Child Behavior Checklist Externalizing T-score

  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.

  3 months post baseline and 6 months post baseline

Secondary Outcomes (3)

• 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

Other Outcomes (2)

• Parental Stress

  3 months post baseline and 6 months post baseline

• Positive Attitude Towards Child

  3 months post baseline and 6 months post baseline

Study Arms (3)

I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching

ACTIVE COMPARATOR

Behavioral: I-InTERACT Parenting Intervention (I2P) and coaching sessions

I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching

ACTIVE COMPARATOR

Behavioral: I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions

Internet Resource Group

OTHER

Control condition

Other: Internet Resources

Interventions

I-InTERACT Parenting Intervention (I2P) and coaching sessions BEHAVIORAL

Online learning sessions for parents of preterm children

I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching

I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions BEHAVIORAL

Online microlearning sessions for parents of preterm children

I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching

Internet Resources OTHER

control condition

Internet Resource Group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Shari Wade, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shari Wade, PhD

CONTACT

5134610952; shari.wade@cchmc.org

Kaylen McCullough, BS

CONTACT

8595336164; kaylen.mccullough@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Masking for outcomes assessor for DPICS study measure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: January 9, 2025
• Study Start: November 27, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)