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OpenTrials
Active, Not Recruiting

NCT Number: NCT05282628

I-InTERACT Preterm

Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

36 month–96 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

The investigators will modify I-InTERACT North to reflect United States language and culture and emphasize our focus on neural plasticity and development. The modified intervention will be renamed Building Better Brains and Behavior (B4 Preterm). Then, investigators will conduct a single-arm clinical trial to establish B4 Preterm's feasibility, acceptability and preliminary efficacy in improving child and family outcomes. Additionally, neuroimaging (MRI/DTI) will be collected pre- and post-intervention. The primary neuroimaging sequence will allow the investigators to examine associations between white matter injury and treatment response as well as changes in neural activation and connectivity pre- to post-treatment. An exploratory neuroimaging sequence will also be collected pre- and post-intervention. This exploratory sequence will serve as a backup for the primary sequence in case it is affected by significant motion and allow the investigators to test this sequence in young children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age at enrollment: ages 3-8, inclusive
  • 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 OR documented behavioral problems noted in medical chart and parent endorses current concerns about child's behaviors
  • Language: English must be the primary spoken language in the home

Exclusion criteria

Caregiver must be 18 years or older to participate in the intervention. 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. Additionally, caregivers with a psychiatric hospitalization in the past year will be ineligible to participate. Children with certain types of metal in their heads will be unable to participate in the MRI portion but will be able to participate in the intervention and complete pre- and post-intervention questionnaires.

Treatment and study plan

Building Better Brains and Behavior program (B4 Preterm)

Behavioral

The program couples online learning modules with video conferencing sessions with a trained therapist to review skills and practice implementing the skills with live coaching. Online modules include didactic content, video clips of parents modeling the skills, and exercises. Parents will complete intervention modules sequentially in conjunction with scheduled 1:1 videoconference sessions with a trained therapist. Videoconference sessions with the therapist will be scheduled weekly, once parents have completed their modules. During these sessions, the therapist will review the online materials and provide active coaching to the parent on how to use the skills with their child (e.g., labeled praise, reflective responses). Each session follows a manualized therapy protocol to optimize content fidelity. Parents will be instructed to practice the parenting skills for 5 minutes each day to promote mastery in the home environment.

Primary outcomes

  1. Eyberg Child Behavior Inventory (ECBI)

    Time frame: Week 1

    Child Behavior

  2. Eyberg Child Behavior Inventory (ECBI)

    Time frame: Week 10

    Child Behavior

  3. Child Behavior Checklist

    Time frame: Week 1

    Child Behavior

  4. Child Behavior Checklist

    Time frame: Week 10

    Child Behavior

  5. Behavior Rating Inventory of Executive Functions-2

    Time frame: Week 1

    Executive Function Behaviors

  6. Behavior Rating Inventory of Executive Functions-2

    Time frame: Week 10

    Executive Function Behaviors

  7. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: Week 1

    Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

  8. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: Week 10

    Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

  9. Adverse Childhood Experiences Scales (ACES)

    Time frame: Week 1

    Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.

  10. Adverse Childhood Experiences Scales (ACES)

    Time frame: Week 10

    Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.

  11. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: Week 1

    Child functioning and quality of life

  12. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: Week 10

    Child functioning and quality of life

  13. Dyadic Parent Child Interaction Coding System (DPICS)

    Time frame: Week 1

    Parenting Behaviors

  14. Dyadic Parent Child Interaction Coding System (DPICS)

    Time frame: Week 10

    Parenting Behaviors

  15. Satisfaction Survey

    Time frame: Week 10

    Satisfaction with Intervention

Secondary outcomes

  1. Multi-shell diffusion sequence

    Time frame: Week 1

    Neuroimaging-MRI/DTI

  2. Multi-shell diffusion sequence

    Time frame: Week 10

    Neuroimaging-MRI/DTI

  3. 3D-T1 weighted sequences

    Time frame: Week 1

    Neuroimaging-MRI/DTI

  4. 3D-T1 weighted sequences

    Time frame: Week 10

    Neuroimaging-MRI/DTI

  5. 3D T2- weighted sequence

    Time frame: Week 1

    Neuroimaging-MRI/DTI

  6. 3D T2- weighted sequence

    Time frame: Week 10

    Neuroimaging-MRI/DTI

  7. Resting state fMRI sequence

    Time frame: Week 1

    Neuroimaging-MRI/DTI

  8. Resting state fMRI sequence

    Time frame: Week 10

    Neuroimaging-MRI/DTI

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2022
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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