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

JRCT ID: jRCT1040240068

Registered date:08/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Late-preterm birth children
• Date of first enrollment: 30/08/2024
• Target sample size: 80
• Study type: Interventional

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

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: <= 3age old
• Gender: Both

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

• Primary Sponsor: Yamada Rie