The Use of Nursing-students-led bCBTMI

NCT05897359 | Unknown

• 1 other identifier: bCBTMI-Adolescents
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The use of the internet is very popular in adolescence. Notwithstanding the benefits from the internet, many users are addicted to the internet and develop problematic behaviours which are regarded as "Internet addiction" (IA). Trained nursing students, who are the future nurses and well-equipped with basic health knowledge, as the interventionists to deliver a bCBTMI intervention to the eligible subjects. The result of this study is expected to provide evidence of the feasibility and effectiveness of training nursing students to conduct bCBTMI in Hong Kong Chinese adolescents with IA for a definitive RCT.

Conditions

Internet Addiction

Keywords

Adolescents; Nursing-students-led; Cognitive Behavioural therapy; Motivational Interviewing

Outcome Measures

Primary Outcomes (10)

• Screening rate

  Calculated as the number of students screened at participated secondary schools divided by number of students at participated schools during the recruitment period.

  at day 1

• Eligibility rate

  Calculated by dividing the number of secondary school students who are eligible by the number who are screened.

  at day 1

• Consent rate

  Calculated by dividing the number of secondary school students who consent to join the study by the number who are eligible.

  at the 6-month follow-up

• Randomization rate

  Calculated by dividing the number of secondary school students who are randomized into intervention and control groups by those who provide consent.

  at day 1

• Attendance rate

  Calculated by dividing the number of secondary school students who complete the intervention by those who are randomized.

  Immediately after the bCBTMI intervention

• Retention rate

  Calculated by dividing the number of secondary school students who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.

  at the 6-month follow-up

• Adherence to intervention protocol

  Calculated by dividing the number of secondary school students who follow the intervention protocol by those who are randomized.

  at the 1-month follow-up

• Complete rate

  Calculated by dividing the number of secondary school students who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.

  at the 6-month follow-up

• Missing data

  Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.

  at the 6-month follow-up

• Adverse events

  Are defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study. The relation to the intervention will be assessed in accordance with the protocol for adverse events management (It can be provided upon request). The number and event severity will be recorded. Numbers and reasons for exclusions will be noted.

  at the 6-month follow-up

Secondary Outcomes (16)

• Self-reported abstinence at the 1-week follow-up

  at the 1-week follow-up

• Self-reported abstinence at the 1-month follow-up

  at the 1-month follow-up

• Self-reported abstinence at the 3-month follow-up

  at the 3-month follow-up

• Self-reported abstinence at the 6-month follow-up

  at the 6-month follow-up

• The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)

  at the 1-week follow-up

Study Arms (2)

bCBTMI

EXPERIMENTAL

bCBTMI care for IA.

Behavioral: bCBTMI

Control

PLACEBO COMPARATOR

Routine care for IA.

Behavioral: Control

Interventions

bCBTMI BEHAVIORAL

This experimental group involves 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by trained nursing students.

bCBTMI

Control BEHAVIORAL

The control group will receive health talks about internet addiction consequences and impacts on young people by nursing students who are not involved in the intervention group to mimic the time and attention spent on the intervention group. These health talks are considered routine care for IA health promotion.

Control

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 13 to 17
• Studying Forms 2 to 4
• Classified as IA by the Chinese version of Young's 10-item Internet Addiction Test (IAT)
• Can communicate in Cantonese and read Chinese.

You may not qualify if:

• With physical or cognitive impairment and learning problems as identified from the medical records

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Katherine Lam

Hong Kong, Hong Kong,China, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology Addiction; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Ka Wai Katherine Lam

  School of Nursing, Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Wai Katherine Lam

CONTACT

27666420; kw-katherine.lam@polyu.edu.hk

Ka Yan Ho

CONTACT

2766417; kyeva.ho@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 9, 2023
• Study Start: September 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 9, 2023

Record last verified: 2023-05

Locations

HK (1)