The Use of Nursing-students-led bCBTMI

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05897359
Collaborator
(none)
60
1
2
20
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: bCBTMI
  • Behavioral: Control
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Use of Nursing-students-led bCBTMI for Internet Addiction Among Adolescents: a Feasibility Cluster Randomised Controlled Trial
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: bCBTMI

bCBTMI care for IA.

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.

Placebo Comparator: Control

Routine care for IA.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Screening rate [at day 1]

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

  2. Eligibility rate [at day 1]

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

  3. Consent rate [at the 6-month follow-up]

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

  4. Randomization rate [at day 1]

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

  5. Attendance rate [Immediately after the bCBTMI intervention]

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

  6. Retention rate [at the 6-month follow-up]

    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.

  7. Adherence to intervention protocol [at the 1-month follow-up]

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

  8. Complete rate [at the 6-month follow-up]

    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.

  9. Missing data [at the 6-month follow-up]

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

  10. Adverse events [at the 6-month follow-up]

    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

  1. Self-reported abstinence at the 1-week follow-up [at the 1-week follow-up]

    Measured by the number of IA symptoms via a self-reported questionnaire.

  2. Self-reported abstinence at the 1-month follow-up [at the 1-month follow-up]

    Measured by the number of IA symptoms via a self-reported questionnaire.

  3. Self-reported abstinence at the 3-month follow-up [at the 3-month follow-up]

    Measured by the number of IA symptoms via a self-reported questionnaire.

  4. Self-reported abstinence at the 6-month follow-up [at the 6-month follow-up]

    Measured by the number of IA symptoms via a self-reported questionnaire.

  5. The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC) [at the 1-week follow-up]

    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.

  6. The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC) [at the 1-month follow-up]

    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.

  7. The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC) [at the 3-month follow-up]

    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.

  8. The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC) [at the 6-month follow-up]

    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.

  9. Anxiety level [at the 1-week follow-up]

    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.

  10. Anxiety level [at the 1-month follow-up]

    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.

  11. Anxiety level [at the 3-month follow-up]

    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.

  12. Anxiety level [at the 6-month follow-up]

    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.

  13. Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI) [at the 1-week follow-up]

    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.

  14. Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI) [at the 1-month follow-up]

    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.

  15. Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI) [at the 3-month follow-up]

    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.

  16. Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI) [at the 6-month follow-up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Katherine Lam Hong Kong Hong Kong,China Hong Kong 0000

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Ka Wai Katherine Lam, School of Nursing, Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Katherine Lam, Research Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT05897359
Other Study ID Numbers:
  • bCBTMI-Adolescents
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Katherine Lam, Research Assistant Professor, The Hong Kong Polytechnic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2023