臨床研究等提出・公開システム

Date of registration	Aug. 23, 2024
Last modified on	Aug. 23, 2024
Trial ID	jRCT1050240114

Scientific Title	Exploring the Benefits of an Online Psychoeducation Program for Adolescents in Japan after Parental Divorce: A Study Using Multiple Baseline Design
Public Title	Exploring the Benefits of an Online Psychoeducation Program for Adolescents in Japan after Parental Divorce

Contact for Scientific Queries	Name	Jikihara Yasumitsu
	Affiliation	Osaka University
	Address	1-2 Yamadaoka, Suita-shi, Osaka-fu 565-0871 Japan
	Telephone	+81-6-6879-8106
	E-mail	jikihara.hus@osaka-u.ac.jp
Contact for Public Queries	Name	Jikihara Yasumitsu
	Affiliation	Osaka University
	Address	1-2 Yamadaoka, Suita-shi, Osaka-fu 565-0871 Japan
	Telephone	+81-6-6879-8106
	E-mail	jikihara.hus@osaka-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 23, 2024
Target sample size		9
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Participants must have experienced parental divorce and be currently within the age range of 12 to 18 years, equivalent to junior high to high school students. They are required to own a computer or tablet with a stable internet connection at home. Additionally, participants must have a smartphone with LINE installed.
	Exclusion Criteria	Participants will be excluded if they are currently involved in court proceedings related to child custody or other matters concerning the child. Additionally, participants with a history of psychiatric or similar treatment will be excluded.
	Age Minimum	12age old over
	Age Maximum	18age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy individuals who have not visited psychiatric or psychosomatic clinics.
Intervention(s)		We designed the intervention program to consist of videos and interactive exercises, delivered in three 60-minute sessions. The primary focus of the program includes: (1) expressing emotions, (2) recognizing thoughts, and (3) developing problem-solving skills.
Primary Outcome(s)		Daily Assessments: 1. Positive and Negative Affect Schedule for Children (PANAS-C) 2. Adolescent's Psychological Distress associated with separation or divorce 3. Generalized Self-Efficacy Scale 4. State Self-Compassion Scale
Secondary Outcome(s)		Pre- and Post-Intervention Assessments: 1. Strength and Difficulties Questionnaire (SDQ) 2. Trust between parent and child 3. Trust in close friendships 4. Open-ended feedback

Primary Sponsor	Jikihara Yasumitsu

Secondary Sponsor

Name of Certified Review Board	Ethics Review Committee, Department of Education, Graduate School of Human Sciences, Osaka University
Address	1-2 Yamadaoka, Suita-shi, Osaka-fu 565-0871 Japan, Osaka
E-Mail	hus-edu-irb@ml.office.osaka-u.ac.jp
Approval Status	Approval
Date of approval	July. 03, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none