I-InTERACT Preterm

Pre-Term Clinical Trial

Official title:

I-InTERACT Preterm

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05282628
• Other study ID #: 315361
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: August 31, 2026

Study information

• Verified date: February 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Months to 96 Months

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Term
• Premature Birth

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eyberg Child Behavior Inventory (ECBI)	Child Behavior	Week 1
Primary	Eyberg Child Behavior Inventory (ECBI)	Child Behavior	Week 10
Primary	Child Behavior Checklist	Child Behavior	Week 1
Primary	Child Behavior Checklist	Child Behavior	Week 10
Primary	Behavior Rating Inventory of Executive Functions-2	Executive Function Behaviors	Week 1
Primary	Behavior Rating Inventory of Executive Functions-2	Executive Function Behaviors	Week 10
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Pediatric Quality of Life Inventory (PedsQL)	Child functioning and quality of life	Week 1
Primary	Pediatric Quality of Life Inventory (PedsQL)	Child functioning and quality of life	Week 10
Primary	Dyadic Parent Child Interaction Coding System (DPICS)	Parenting Behaviors	Week 1
Primary	Dyadic Parent Child Interaction Coding System (DPICS)	Parenting Behaviors	Week 10
Primary	Satisfaction Survey	Satisfaction with Intervention	Week 10
Secondary	Multi-shell diffusion sequence	Neuroimaging-MRI/DTI	Week 1
Secondary	Multi-shell diffusion sequence	Neuroimaging-MRI/DTI	Week 10
Secondary	3D-T1 weighted sequences	Neuroimaging-MRI/DTI	Week 1
Secondary	3D-T1 weighted sequences	Neuroimaging-MRI/DTI	Week 10
Secondary	3D T2- weighted sequence	Neuroimaging-MRI/DTI	Week 1
Secondary	3D T2- weighted sequence	Neuroimaging-MRI/DTI	Week 10
Secondary	Resting state fMRI sequence	Neuroimaging-MRI/DTI	Week 1
Secondary	Resting state fMRI sequence	Neuroimaging-MRI/DTI	Week 10