I-InTERACT Preterm

NCT05282628 | Active Not Recruiting

• 1 other identifier: 315361
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-Term

Outcome Measures

Primary Outcomes (15)

• Eyberg Child Behavior Inventory (ECBI)

  Child Behavior

  Week 1

• Eyberg Child Behavior Inventory (ECBI)

  Child Behavior

  Week 10

• Child Behavior Checklist

  Child Behavior

  Week 1

• Child Behavior Checklist

  Child Behavior

  Week 10

• Behavior Rating Inventory of Executive Functions-2

  Executive Function Behaviors

  Week 1

• Behavior Rating Inventory of Executive Functions-2

  Executive Function Behaviors

  Week 10

• Center for Epidemiologic Studies Depression Scale (CES-D)

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

  Week 1

• Center for Epidemiologic Studies Depression Scale (CES-D)

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

  Week 10

• Adverse Childhood Experiences Scales (ACES)

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

  Week 1

• Adverse Childhood Experiences Scales (ACES)

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

  Week 10

• Pediatric Quality of Life Inventory (PedsQL)

  Child functioning and quality of life

  Week 1

• Pediatric Quality of Life Inventory (PedsQL)

  Child functioning and quality of life

  Week 10

• Dyadic Parent Child Interaction Coding System (DPICS)

  Parenting Behaviors

  Week 1

• Dyadic Parent Child Interaction Coding System (DPICS)

  Parenting Behaviors

  Week 10

• Satisfaction Survey

  Satisfaction with Intervention

  Week 10

Secondary Outcomes (8)

• Multi-shell diffusion sequence

  Week 1

• Multi-shell diffusion sequence

  Week 10

• 3D-T1 weighted sequences

  Week 1

• 3D-T1 weighted sequences

  Week 10

• 3D T2- weighted sequence

  Week 1

Study Arms (1)

Building Better Brains and Behavior program (B4 Preterm)

EXPERIMENTAL

Online learning modules completed sequentially and in conjunction with live coaching sessions led by a trained therapist.

Behavioral: Building Better Brains and Behavior program (B4 Preterm)

Interventions

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.

Building Better Brains and Behavior program (B4 Preterm)

Eligibility Criteria

• Age: 36 Months - 96 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

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 L Wade, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: March 16, 2022
• Study Start: September 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

US (1)