Clinical Trial: The Effectiveness of Cognitive Behavioral Therapy (CBT) for Parents Facing Difficulties in Managing Their Children's Problematic Internet Use: A Single-Center, Waitlist-Controlled, Randomized Controlled Trial (Japan)

Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059097) titled 'The Effectiveness of Cognitive Behavioral Therapy (CBT) for Parents Facing Difficulties in Managing Their Children's Problematic Internet Use: A Single-Center, Waitlist-Controlled, Randomized Controlled Trial' on Oct. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Chiba Children's Hospital

Condition: Condition - Problematic Internet Use Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to examine the effectiveness of a Cognitive Behavioral Therapy (CBT) program based on Community Reinforcement and Family Training (CRAFT) for parents who have difficulty managing their children's problematic internet use, as compared to a waitlist control group. The primary endpoint will be the score on the Parent version of the Internet Addiction Test (PCIAT), and a significant improvement in this score will be considered evidence of the program's effectiveness. This study aims to build more robust evidence, which is essential for establishing a new support method for adolescents who are resistant to treatment. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - A Cognitive Behavioral Therapy (CBT) program based on Community Reinforcement and Family Training (CRAFT). A total of 6 face-to-face sessions will be conducted once every two weeks, with each session lasting 30 minutes, over a period of 12 weeks. Interventions/Control_2 - Participants will wait for 12 weeks without receiving the intervention. During this period, no specific study intervention will be provided, and usual medical care will continue. After the waiting period, the same CBT program as the intervention group will be offered to those who wish.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Parents who have difficulty managing their child's problematic internet use. Parents of a child who is currently an outpatient at the Psychiatry Department of Chiba Children's Hospital. Parents whose child is between 6 and 18 years of age (inclusive) at the time of informed consent. Parents who are living with the child at the time of informed consent. Individuals who have provided voluntary, written informed consent after receiving a full explanation of the study. Parents who are able to participate in the 12-week face-to-face CBT program and do not have any serious physical or mental illness that would hinder their participation. Key exclusion criteria - Parents who are determined to have difficulty participating in the CBT program due to factors such as significant cognitive impairment. Parents who have received CRAFT-based family therapy or equivalent systematic parent training within the past 6 months. Parents who have difficulty attending a 30-minute session every two weeks on a continuous basis. Individuals otherwise deemed unsuitable for safe participation in the study by the principal investigator. Target Size - 24

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 01 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067604

Disclaimer: Curated by HT Syndication.