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Aug. 08, 2024

Oct. 28, 2024

jRCT1040240068

Effects of Parent-Child Interaction Therapy with Toddlers (PCIT-Toddlers) for parent-child relationship among late preterm infants
: A randomized controlled trial

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

Yamada Rie

Nagoya City University Hospital

Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan

+81-528538760

yrie@med.nagoya-cu.ac.jp

Yamada Rie

Nagoya City University Hospital

Kawasaumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan

+81-528538760

yrie@med.nagoya-cu.ac.jp

Recruiting

Aug. 09, 2024

Aug. 30, 2024
80

Interventional

randomized controlled trial

open(masking not used)

placebo control

parallel assignment

treatment purpose

(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.

(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

1age 0month 0week old over
3age 0month 0week old under

Both

Late-preterm birth children

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.

Late preterm infant, develpmental disorder

Parent-Child Interaction Therapy, PCIT-Toddlers, parent-child relationship

D047928

D018479

Change score between baseline and post-intervention of Devereux Early Childhood Assessment-Toddler (DECA)

Change 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)

Nagoya City University
Nagoya City University Ethics Committee for Medical Research
Kawasumi 1, Mizuho-ku, Nagoya, Aichi, Japan, Aichi

+81-52-853-8346

rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval

July. 22, 2024

No

none

History of Changes

No Publication date
4 Oct. 28, 2024 (this page) Changes
3 Aug. 22, 2024 Detail Changes
2 Aug. 20, 2024 Detail Changes
1 Aug. 08, 2024 Detail