The Use of Nursing-students-led bCBTMI
Primary Purpose
Internet Addiction
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
bCBTMI
Control
Sponsored by
About this trial
This is an interventional treatment trial for Internet Addiction focused on measuring Adolescents, Nursing-students-led, Cognitive Behavioural therapy, Motivational Interviewing
Eligibility Criteria
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
Sites / Locations
- Katherine LamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
bCBTMI
Control
Arm Description
bCBTMI care for IA.
Routine care for IA.
Outcomes
Primary Outcome Measures
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.
Eligibility rate
Calculated by dividing the number of secondary school students who are eligible by the number who are screened.
Consent rate
Calculated by dividing the number of secondary school students who consent to join the study by the number who are eligible.
Randomization rate
Calculated by dividing the number of secondary school students who are randomized into intervention and control groups by those who provide consent.
Attendance rate
Calculated by dividing the number of secondary school students who complete the intervention by those who are randomized.
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.
Adherence to intervention protocol
Calculated by dividing the number of secondary school students who follow the intervention protocol by those who are randomized.
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.
Missing data
Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
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.
Secondary Outcome Measures
Self-reported abstinence at the 1-week follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
Self-reported abstinence at the 1-month follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
Self-reported abstinence at the 3-month follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
Self-reported abstinence at the 6-month follow-up
Measured 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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05897359
First Posted
May 11, 2023
Last Updated
May 31, 2023
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT05897359
Brief Title
The Use of Nursing-students-led bCBTMI
Official Title
The Use of Nursing-students-led bCBTMI for Internet Addiction Among Adolescents: a Feasibility Cluster Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internet Addiction
Keywords
Adolescents, Nursing-students-led, Cognitive Behavioural therapy, Motivational Interviewing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bCBTMI
Arm Type
Experimental
Arm Description
bCBTMI care for IA.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Routine care for IA.
Intervention Type
Behavioral
Intervention Name(s)
bCBTMI
Intervention Description
This experimental group involves 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by trained nursing students.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Screening rate
Description
Calculated as the number of students screened at participated secondary schools divided by number of students at participated schools during the recruitment period.
Time Frame
at day 1
Title
Eligibility rate
Description
Calculated by dividing the number of secondary school students who are eligible by the number who are screened.
Time Frame
at day 1
Title
Consent rate
Description
Calculated by dividing the number of secondary school students who consent to join the study by the number who are eligible.
Time Frame
at the 6-month follow-up
Title
Randomization rate
Description
Calculated by dividing the number of secondary school students who are randomized into intervention and control groups by those who provide consent.
Time Frame
at day 1
Title
Attendance rate
Description
Calculated by dividing the number of secondary school students who complete the intervention by those who are randomized.
Time Frame
Immediately after the bCBTMI intervention
Title
Retention rate
Description
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.
Time Frame
at the 6-month follow-up
Title
Adherence to intervention protocol
Description
Calculated by dividing the number of secondary school students who follow the intervention protocol by those who are randomized.
Time Frame
at the 1-month follow-up
Title
Complete rate
Description
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.
Time Frame
at the 6-month follow-up
Title
Missing data
Description
Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Time Frame
at the 6-month follow-up
Title
Adverse events
Description
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.
Time Frame
at the 6-month follow-up
Secondary Outcome Measure Information:
Title
Self-reported abstinence at the 1-week follow-up
Description
Measured by the number of IA symptoms via a self-reported questionnaire.
Time Frame
at the 1-week follow-up
Title
Self-reported abstinence at the 1-month follow-up
Description
Measured by the number of IA symptoms via a self-reported questionnaire.
Time Frame
at the 1-month follow-up
Title
Self-reported abstinence at the 3-month follow-up
Description
Measured by the number of IA symptoms via a self-reported questionnaire.
Time Frame
at the 3-month follow-up
Title
Self-reported abstinence at the 6-month follow-up
Description
Measured by the number of IA symptoms via a self-reported questionnaire.
Time Frame
at the 6-month follow-up
Title
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Description
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.
Time Frame
at the 1-week follow-up
Title
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Description
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.
Time Frame
at the 1-month follow-up
Title
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Description
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.
Time Frame
at the 3-month follow-up
Title
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Description
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.
Time Frame
at the 6-month follow-up
Title
Anxiety level
Description
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.
Time Frame
at the 1-week follow-up
Title
Anxiety level
Description
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.
Time Frame
at the 1-month follow-up
Title
Anxiety level
Description
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.
Time Frame
at the 3-month follow-up
Title
Anxiety level
Description
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.
Time Frame
at the 6-month follow-up
Title
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
at the 1-week follow-up
Title
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
at the 1-month follow-up
Title
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
at the 3-month follow-up
Title
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
at the 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Wai Katherine Lam
Phone
27666420
Email
kw-katherine.lam@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Yan Ho
Phone
2766417
Email
kyeva.ho@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka Wai Katherine Lam
Organizational Affiliation
School of Nursing, Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katherine Lam
City
Hong Kong
State/Province
Hong Kong,China
ZIP/Postal Code
0000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Lam, Phd
12. IPD Sharing Statement
Learn more about this trial
The Use of Nursing-students-led bCBTMI
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