NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1040240068

Registered date:08/08/2024

A study of the effects of "Parent-Child Interaction Therapy for Infants (PCIT-Toddlers)" on the parent-child relationship in late preterm infants.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPreterm Birth
Date of first enrollment09/08/2024
Target sample size80
Countries of recruitment
Study typeInterventional
Intervention(s)The intervention group will be provided with a live coach to help caregivers develop a "Parent-Child Interaction Therapy with Toddlers" (hereafter PCIT-Toddlers), an intervention that aims to promote qualitative improvements in parent-child playground interactions, and a "Child DirectedInteraction-Toddler ("CDI-T"), an intervention that aims to promote qualitative improvement of parent-child playground interaction.The duration of the program will be 4 months, 40 minutes per session, and a total of 6 sessions will be conducted either in person or via the Internet.For the control group, the principal investigator will send the caregivers a parenting communication via text message application (6 sessions in total) during the 4-month period.Each parenting communication will provide six general parenting topics: exercise, play, social skills, diet, lifestyle, and comprehension language.

Outcome(s)

Primary OutcomeDECA-Toddler : Devereux Early Childhood Assessment (provisional Japanese version of DECA)
Secondary OutcomeThe Brief Infant Toddler Social Emotional Assessment Parenting Stress Index short form Dyadic Parent Child Interaction Coding System

Key inclusion & exclusion criteria

Age minimum>= 1age old
Age maximum<= 3age old
GenderBoth
Include criteria(1) Children between 1 year and 2 years and 6 months old at the time of recruitment among those who survived and were discharged from our NICU (2) Children born between 34 weeks 0 days and 36 weeks 6 days of gestation (3) Primary caregiver who lives with the child and can be involved with the child daily
Exclude criteria(1) When a caregiver refuses to participate in this study (2) When a child survives and is discharged from the hospital due to multiple births (two or more children) (3) When a child has chromosomal abnormalities or obvious visual, auditory, or motor impairments (4) When a caregiver lives separately from the child (5) When a caregiver uses a language other than Japanese (6) When the principal investigator determines that it is difficult to conduct the study (7) When a child is receiving individual parent-child or(vii) When the principal investigator judges that it is difficult to conduct the research.

Related Information

Contact

Public contact
Name Rie Yamada
Address Mizuho-ku Aichi Japan 467-8601
Telephone +81-528538760
E-mail yrie@med.nagoya-cu.ac.jp
Affiliation Nagoya City University Hospital
Scientific contact
Name Rie Yamada
Address Mizuho-ku Aichi Japan 467-8601
Telephone +81-528538760
E-mail yrie@med.nagoya-cu.ac.jp
Affiliation Nagoya City University Hospital