NIPH Clinical Trials Search

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

Registered date:08/08/2024

Parent-Child Interaction Therapy with Toddlers (PCIT-Toddlers) for late preterm infants and their parents.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedLate-preterm birth children
Date of first enrollment30/08/2024
Target sample size80
Countries of recruitment
Study typeInterventional
Intervention(s)Intervention: The Child-Directed Interaction-Toddler (CDI-T) module of Parent-Child Interaction Therapy with Toddlers (PCIT-Toddlers). CDI-T provides live coaching to improve parent-child interactions through playing. The program consists of six 40-minute sessions over four months, either in person or via the Internet. Control condition: "Parenting Tips" via text message application, provided six times during the 4 months. "Parenting Tips" comprises six general topics: exercise, play, social skills, diet, lifestyle, and language comprehension.

Outcome(s)

Primary OutcomeChange score between baseline and post-intervention of Devereux Early Childhood Assessment-Toddler (DECA)
Secondary OutcomeChange score between baseline and post-intervention of Brief Infant Toddler Social Emotional Assessment (BITSEA) Change score between baseline and post-intervention of Parenting Stress Index Short Form (PSI-SF) Change score between baseline and post-intervention of Dyadic Parent-Child Interaction Coding System-IV (DIPICS-IV)

Key inclusion & exclusion criteria

Age minimum>= 1age old
Age maximum<= 3age old
GenderBoth
Include criteria(1) Child aged between 1 and 2.5 years old at the time of recruitment and discharged NICU when they are newborn babies (2) Child born between 34 weeks 0 days and 36 weeks six days gestation. (3) Primary caregiver lives with the participating child and can be involved with them daily.
Exclude criteria(1) Primary caregivers refuse to participate in the trial (2) Child with multiple births (two or more children) (3) Child with chromosomal abnormalities or obvious visual, auditory, or motor impairments (4) Caregiver who lives separately from the child (5) Caregiver who uses a language other than Japanese (6) Candidate who assessed difficulty in participating in the study by the principal investigator (7) Child receiving individual parent-child based treatment

Related Information

Contact

Public contact
Name Rie Yamada
Address Kawasaumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan 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 Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan Aichi Japan 467-8601
Telephone +81-528538760
E-mail yrie@med.nagoya-cu.ac.jp
Affiliation Nagoya City University Hospital