The Use of Nursing-students-led bCBTMI

Internet Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897359
• Other study ID #: bCBTMI-Adolescents
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: The Hong Kong Polytechnic University
• Contact: Ka Wai Katherine Lam
• Phone: 27666420
• Email: kw-katherine.lam[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Internet Addiction

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Katherine Lam	Hong Kong	Hong Kong,China

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Eligibility rate	Calculated by dividing the number of secondary school students who are eligible by the number who are screened.	at day 1
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Self-reported abstinence at the 1-week follow-up	Measured by the number of IA symptoms via a self-reported questionnaire.	at the 1-week follow-up
Secondary	Self-reported abstinence at the 1-month follow-up	Measured by the number of IA symptoms via a self-reported questionnaire.	at the 1-month follow-up
Secondary	Self-reported abstinence at the 3-month follow-up	Measured by the number of IA symptoms via a self-reported questionnaire.	at the 3-month follow-up
Secondary	Self-reported abstinence at the 6-month follow-up	Measured by the number of IA symptoms via a self-reported questionnaire.	at the 6-month follow-up
Secondary	The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)	CES-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.	at the 1-week follow-up
Secondary	The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)	CES-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.	at the 1-month follow-up
Secondary	The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)	CES-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.	at the 3-month follow-up
Secondary	The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)	CES-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.	at the 6-month follow-up
Secondary	Anxiety level	The 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.	at the 1-week follow-up
Secondary	Anxiety level	The 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.	at the 1-month follow-up
Secondary	Anxiety level	The 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.	at the 3-month follow-up
Secondary	Anxiety level	The 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.	at the 6-month follow-up
Secondary	Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)	It 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.	at the 1-week follow-up
Secondary	Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)	It 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.	at the 1-month follow-up
Secondary	Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)	It 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.	at the 3-month follow-up
Secondary	Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)	It 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.	at the 6-month follow-up