Pre-Term Clinical Trial
Official title:
I-InTERACT Preterm
Verified date | February 2024 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
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 |
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