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The Use of Nursing-students-led bCBTMI

The Use of Nursing-students-led bCBTMI for Internet Addiction Among Adolescents: a Feasibility Cluster Randomised Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05897359
Enrollment
60
Registered
2023-06-09
Start date
2022-09-01
Completion date
2024-05-01
Last updated
2023-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Internet Addiction

Keywords

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

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.

Detailed description

A two-arm, parallel-group, feasibility cluster randomized controlled trial will be conducted. 60 adolescents with IA will be recruited from secondary schools in Hong Kong. Participants in the intervention group will receive 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by nursing students. Control group participants will receive routine care for IA.

Interventions

BEHAVIORALbCBTMI

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

BEHAVIORALControl

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse eventsat the 6-month follow-upAre 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.
Screening rateat day 1Calculated as the number of students screened at participated secondary schools divided by number of students at participated schools during the recruitment period.
Eligibility rateat day 1Calculated by dividing the number of secondary school students who are eligible by the number who are screened.
Consent rateat the 6-month follow-upCalculated by dividing the number of secondary school students who consent to join the study by the number who are eligible.
Randomization rateat day 1Calculated by dividing the number of secondary school students who are randomized into intervention and control groups by those who provide consent.
Attendance rateImmediately after the bCBTMI interventionCalculated by dividing the number of secondary school students who complete the intervention by those who are randomized.
Retention rateat the 6-month follow-upCalculated 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.
Adherence to intervention protocolat the 1-month follow-upCalculated by dividing the number of secondary school students who follow the intervention protocol by those who are randomized.
Missing dataat the 6-month follow-upCalculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Complete rateat the 6-month follow-upCalculated 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.

Secondary

MeasureTime frameDescription
Self-reported abstinence at the 1-month follow-upat the 1-month follow-upMeasured by the number of IA symptoms via a self-reported questionnaire.
Self-reported abstinence at the 3-month follow-upat the 3-month follow-upMeasured by the number of IA symptoms via a self-reported questionnaire.
Self-reported abstinence at the 6-month follow-upat the 6-month follow-upMeasured by the number of IA symptoms via a self-reported questionnaire.
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)at the 1-week follow-upCES-DC will be used to record the number of depression symptoms in secondary schools students with IA at each follow-up. It includes 20 items asking on a 4-point Likert scale in relation to the incidence of the stated symptoms during the previous week, and are scored from 0 to 3 (0 = not at all, 3 = a lot). Total scores range from 0 to 60, with higher scores indicating greater number of depressive symptoms. This questionnaire has been empirically tested and validated in Hong Kong children and are currently using in Youth Quitline.
Anxiety levelat the 1-week follow-upThe anxiety level of secondary school students with IA will be measured by the short form of the Chinese Version of the State Anxiety Scale for Children (CSAS-C) at each follow-up. It has 10 itmes with scores from 1 to 3. Total scores range from 10 to 30, with higher scores indicating a higher level of anxiety. This questionnaire has been empirically tested and validated in Hong Kong children.
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)at the 1-week follow-upIt contains 19 items measuring 7 domains: subjective sleep quality, latency, duration, habitual efficiency, disturbances, use of medication, and daytime dysfunction on a 3-point scale (0: no difficulty to 3: severe difficulty) except for the items reporting bedtime and time awake. The sum of the seven component scores produces a global score with higher scores represent poorer subjective sleep quality. It has been validated in Hong Kong children and adolescents previously.
Self-reported abstinence at the 1-week follow-upat the 1-week follow-upMeasured by the number of IA symptoms via a self-reported questionnaire.

Countries

Hong Kong

Contacts

Primary ContactKa Wai Katherine Lam
kw-katherine.lam@polyu.edu.hk27666420
Backup ContactKa Yan Ho
kyeva.ho@polyu.edu.hk2766417

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026