An Evaluation of the Effectiveness of Support for Families of Patients with Avoidant/Restrictive Food Intake Disorder

JRCT ID: jRCT1050240148

Registered date:04/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Avoidant/Restrictive Food Intake Disorder
• Date of first enrollment: 04/10/2024
• Target sample size: 4
• Study type: Interventional
• Intervention(s): The study will consist of three one-hour psychoeducation sessions.The psychoeducation will consist of information and discussion on "Understanding ARFID," "Working with Children with ARFID," and "Caring for Parents."Study subjects selected by DSM-5 diagnosis before entry begins will be provided with psychoeducation, and psychometric and saliva sampling will be conducted before and after the education.In addition, psychometric and saliva sampling will be conducted again after a one-month follow-up period.The results of psychometric scores and saliva stress assessment indices (cortisol, alpha-amylase, DHEA, and oxytocin) obtained after the end of the intervention will be used to evaluate whether or not the psycho-education is effective.

Outcome(s)

• Primary Outcome: 12-item General Health Questionnaire Japanese version
• Secondary Outcome: Beck Depression Inventory-Second Edition, Zarit Caregiver Burden Interview-8, Stress indicators in saliva (cortisol, alpha-amylase, DHEA, oxytocin)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Parents whose children are attending the University of Fukui Hospital for treatment of ARFID, etc. and who meet all of the following criteria are eligible for this study.
1. age of the child: less than 18 years old
2. gender: both parent and child are unspecified
3. diagnosis of the child: the child must have been diagnosed with ARFID by the attending physician based on DSM-5
4. persons who have received a full explanation of their participation in this study, and who have given their free and voluntary written consent based on a full understanding of the

Exclude criteria

1.Individuals who have been diagnosed with any psychiatric disorder.
2.Other individuals deemed unsuitable as research subjects by the principal investigator.

Related Information

• Primary Sponsor: Hirai Takaharu