Clinical trial NCT05282628: I-InTERACT Preterm
Official title: I-InTERACT Preterm
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pre-Term
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 19
Sex: ALL
Minimum age (years): 36
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eyberg Child Behavior Inventory (ECBI)
timeFrame: Week 1
measure: Eyberg Child Behavior Inventory (ECBI)
timeFrame: Week 10
measure: Child Behavior Checklist
timeFrame: Week 1
measure: Child Behavior Checklist
timeFrame: Week 10
measure: Behavior Rating Inventory of Executive Functions-2
timeFrame: Week 1
measure: Behavior Rating Inventory of Executive Functions-2
timeFrame: Week 10
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Week 1
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Week 10
measure: Adverse Childhood Experiences Scales (ACES)
timeFrame: Week 1
measure: Adverse Childhood Experiences Scales (ACES)
timeFrame: Week 10
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Week 1
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Week 10
measure: Dyadic Parent Child Interaction Coding System (DPICS)
timeFrame: Week 1
measure: Dyadic Parent Child Interaction Coding System (DPICS)
timeFrame: Week 10
measure: Satisfaction Survey
timeFrame: Week 10
Secondary outcomes:
measure: Multi-shell diffusion sequence
timeFrame: Week 1
measure: Multi-shell diffusion sequence
timeFrame: Week 10
measure: 3D-T1 weighted sequences
timeFrame: Week 1
measure: 3D-T1 weighted sequences
timeFrame: Week 10
measure: 3D T2- weighted sequence
timeFrame: Week 1
measure: 3D T2- weighted sequence
timeFrame: Week 10
measure: Resting state fMRI sequence
timeFrame: Week 1
measure: Resting state fMRI sequence
timeFrame: Week 10
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Shari L Wade, PhD
role: PRINCIPAL_INVESTIGATOR
References: