Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT05282628
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.
This study is active but is not currently recruiting participants.
36 month–96 month
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45229, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
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.
Time frame: Week 1
Child Behavior
Time frame: Week 10
Child Behavior
Time frame: Week 1
Child Behavior
Time frame: Week 10
Child Behavior
Time frame: Week 1
Executive Function Behaviors
Time frame: Week 10
Executive Function Behaviors
Time frame: Week 1
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time frame: Week 10
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time frame: Week 1
Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.
Time frame: Week 10
Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.
Time frame: Week 1
Child functioning and quality of life
Time frame: Week 10
Child functioning and quality of life
Time frame: Week 1
Parenting Behaviors
Time frame: Week 10
Parenting Behaviors
Time frame: Week 10
Satisfaction with Intervention
Time frame: Week 1
Neuroimaging-MRI/DTI
Time frame: Week 10
Neuroimaging-MRI/DTI
Time frame: Week 1
Neuroimaging-MRI/DTI
Time frame: Week 10
Neuroimaging-MRI/DTI
Time frame: Week 1
Neuroimaging-MRI/DTI
Time frame: Week 10
Neuroimaging-MRI/DTI
Time frame: Week 1
Neuroimaging-MRI/DTI
Time frame: Week 10
Neuroimaging-MRI/DTI
Children's Hospital Medical Center, Cincinnati
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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