I-InTERACT Preterm

Study Overview
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Brief Summary
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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
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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.

Official Title
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I-InTERACT Preterm

Conditions
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Pre-Term

Intervention / Treatment
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* Behavioral: Building Better Brains and Behavior program (B4 Preterm)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 96 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Building Better Brains and Behavior program (B4 Preterm)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-shell diffusion sequence | Neuroimaging-MRI/DTI | Week 1 | 
| Multi-shell diffusion sequence | Neuroimaging-MRI/DTI | Week 10 | 
| 3D-T1 weighted sequences | Neuroimaging-MRI/DTI | Week 1 | 
| 3D-T1 weighted sequences | Neuroimaging-MRI/DTI | Week 10 | 
| 3D T2- weighted sequence | Neuroimaging-MRI/DTI | Week 1 | 
| 3D T2- weighted sequence | Neuroimaging-MRI/DTI | Week 10 | 
| Resting state fMRI sequence | Neuroimaging-MRI/DTI | Week 1 | 
| Resting state fMRI sequence | Neuroimaging-MRI/DTI | Week 10 |