Home » Trials » SLCTR/2025/008
Efficacy of app-supported parent-adolescent communication on sexual and reproductive health: an application of information-motivation and behavioural skill model
-
SLCTR Registration Number
SLCTR/2025/008
Date of Registration
The date of last modification
Mar 17, 2025
Scientific Title of Trial
Efficacy of app-supported parent-adolescent communication on sexual and reproductive health: an application of information-motivation and behavioural skill model
Public Title of Trial
Web-Based vs. Traditional Interventions to Improve Parent-Adolescent Sexual and Reproductive Health (SRH) Communication: An Information, Motivation and Behavioural skills (IMB) Model Approach
Disease or Health Condition(s) Studied
Sexual and Reproductive Health
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1319-348
Any other number(s) assigned to the trial and issuing authority
Ethics Reference Number: FME/23/59
What is the research question being addressed?
Is parent-adolescent Sexual Reproductive Health communication assisted by apps more efficient than conventional forms of communication?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used : Participants
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 1-2
Intervention(s) planned
Study Setting • The study will be conducted in three districts within Sarawak, Malaysia: Kuching, Padawan, and Samarahan.
• Target Population: Adolescent-parent dyads, where the adolescent is aged 16-19 years, and the parent can be either the mother, father, or guardian.
• Recruitment: Participants will be recruited through community centers, and local village heads (Penghulu/Ketua Kaum) to ensure a broad representation of the community.
• Intervention
Content (Shared Across Both Groups): Both groups will cover the same Sexual Reproductive Health (SRH) topics: - Sexual growth and development - Risky sexual behaviours and prevention - Contraception - Communication skills between parents and adolescents
Intervention Arm:
o App-Supported Group:
Dyads will receive access to a mobile/web-based app designed for SRH communication.
Features of the app: Interactive modules covering key SRH topics such as sexual growth, contraception, teenage pregnancy, and communication skills. How will compliance with interactive modules be ensured? • Tracking & Monitoring: The web-based platform records logins, time spent on modules and completed activities. • Quizzes & Assessments: Participants complete quizzes to ensure content engagement. • Reminders & Follow-ups: Automated SMS/email reminders encourage module completion. • Parental Involvement: Encouraging parents to engage with adolescents to reinforce learning.
Participants engage in self-paced learning with optional interactive discussions. Engagement is encouraged at least once a week for 30–60 minutes.
Weekly notifications or prompts (via "Risebot") to encourage engagement with specific modules or tasks. Discussion forums or chat support for addressing questions.
Duration: The app will remain accessible to participants for 1 year.
Frequency: Participants will receive weekly prompts and tasks for the first 3 months, with periodic check-ins (e.g., monthly notifications) for the remainder of the year.
Support: Virtual technical assistance will be provided to help participants navigate the app and resolve any issues.
o Conventional Group: Dyads will participate in group-based 4–5-hour seminars held in their respective villages. The seminars will include interactive sessions facilitated by trained healthcare providers or educators.
Seminars are the standard method for SRH communication in the community.
Content of the seminar: Presentations and discussions on SRH topics such as sexual growth, contraception, teenage pregnancy, and parent-adolescent communication skills. Goup activities and role-playing exercises to practice effective communication. Frequency: Participants will attend a single seminar session, with reinforcement provided via SMS or calls at 1 month and 3 months post-seminar to reinforce key messages.
Setting: Seminars will be conducted in community halls or other central locations within the villages.
Both interventions provide the same content, differing only in delivery—web-based or seminar-based. The IMB model, widely used in SRH education, is applied in both interventions.
Study Duration • Intervention Period: o App group: 3 months of active engagement with app features. o Conventional group: A single 4–5-hour seminar in their village, with follow-up reminders at 1 month and 3 months.
• Overall Timeline: Recruitment, intervention, and follow-up assessments are expected to be completed within 6 months and another 6 months for analysis, interpreting and writing.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
To determine the efficacy of app-supported parent-adolescent sexual and reproductive health (SRH) communication by applying the Information-Motivation-Behavioural Skills (IMB) model, measured using: A validated SRH communication questionnaire assessing changes in knowledge, motivation, and behavioural skills at baseline, |
[ 1 month, and 3 months post-intervention. ] |
2.
An app evaluation questionnaire for participants in the app-supported group. |
[ 1 month, and 3 months post-intervention. ] |
3.
A seminar evaluation questionnaire for participants in the conventional group. |
[ 1 month, and 3 months post-intervention. ] |
4.
An app evaluation questionnaire for participants in the app-supported group. |
[ Bseline, 1 month, and 3 months post-intervention. ] |
5.
A seminar evaluation questionnaire for participants in the conventional group. |
[ Baseline,1 month, and 3 months post-intervention. ] |
6.
An app evaluation questionnaire for participants in the app-supported group. |
[ Bseline, 1 month, and 3 months post-intervention. ] |
7.
A seminar evaluation questionnaire for participants in the conventional group. |
[ Baseline,1 month, and 3 months post-intervention. ] |
8.
An app evaluation questionnaire for participants in the app-supported group. |
[ Bseline, 1 month, and 3 months post-intervention. ] |
9.
A seminar evaluation questionnaire for participants in the conventional group. |
[ Baseline,1 month, and 3 months post-intervention. ] |
10.
An app evaluation questionnaire for participants in the app-supported group. |
[ Bseline, 1 month, and 3 months post-intervention. ] |
11.
A seminar evaluation questionnaire for participants in the conventional group. |
[ Baseline,1 month, and 3 months post-intervention. ] |
12.
An app evaluation questionnaire for participants in the app-supported group. |
[ Bseline, 1 month, and 3 months post-intervention. ] |
13.
A seminar evaluation questionnaire for participants in the conventional group. |
[ Baseline,1 month, and 3 months post-intervention. ] |
14.
An app evaluation questionnaire for participants in the app-supported group. |
[ Bseline, 1 month, and 3 months post-intervention. ] |
15.
A seminar evaluation questionnaire for participants in the conventional group. |
[ Baseline,1 month, and 3 months post-intervention. ] |
16.
An app evaluation questionnaire for participants in the app-supported group. |
[ Bseline, 1 month, and 3 months post-intervention. ] |
17.
A seminar evaluation questionnaire for participants in the conventional group. |
[ Baseline,1 month, and 3 months post-intervention. ] |
Secondary outcome(s)
1.
To determine the relationship between information and parent-adolescent SRH communication, mediated by behavioural skills. Measured Outcomes: Knowledge levels regarding SRH topics (information), assessed using a validated SRH knowledge questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
2.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
3.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
4.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
5.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
6.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
7.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
8.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
9.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
10.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
11.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
12.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
13.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
14.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
15.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
16.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
17.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
18.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
19.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
20.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
21.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
22.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
23.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
24.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
25.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
26.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
27.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
28.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
29.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
30.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
31.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
32.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
33.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
34.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
35.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
36.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
37.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
38.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
39.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
40.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
41.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
42.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
43.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
44.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
45.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
46.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
47.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
48.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
49.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
50.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
51.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
52.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
53.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
54.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
55.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
56.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
57.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
58.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
59.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
60.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
61.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
62.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
63.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
64.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
65.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
66.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
67.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
68.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
69.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
70.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
71.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
72.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
73.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
74.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
75.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
76.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
77.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH communication evaluated through a structured SRH communication questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
78.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
79.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
80.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
81.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
82.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
83.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
84.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
85.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
86.
Behavioural skills in SRH communication (e.g., ability to listen, express feelings, ask questions), measured using a parent-adolescent communication skills scale. |
[ Baseline,1 month, and 3 months post-intervention. ] |
87.
Frequency, quality, and openness of parent-adolescent SRH communication, evaluated through a structured SRH questionnaire. |
[ Baseline,1 month, and 3 months post-intervention. ] |
Target number/sample size
200 dyads (parent-adolescent pairs) in each group
Countries of recruitment
Malaysia
Anticipated start date
2025-03-15
Anticipated end date
2025-07-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Universiti Malaysia Sarawak
Regulatory approvals
Medical Research Ethics Committee
Status
Approved
Date of Approval
2023-08-24
Approval number
FME/23/59
Details of Ethics Review Committee
Name: | Medical Research Ethics Committee, Universiti Malaysia Sarawak (UNIMAS) |
Institutional Address: | Deputy Vice Chancellor’s Office (Research and Innovation), Medical Research Ethics Committee, Universiti Malaysia Sarawak, 94300 Kota Samarahan, Sarawak, Malaysia. |
Telephone: | 082 581222/1223 |
Email: | medicalethics@unimas.my |
Contact person for Scientific Queries/Principal Investigator
Rafazila Ramli
Faculty of Medicine and Health Sciences,
Universiti Malaysia Sarawak,
94300 Kota Samarahan,
Sarawak, Malaysia
+601169341808
Nil
rmmizanur@unimas.my
Nil
Contact Person for Public Queries
Dr Md Mizanur Rahman
Professor
Faculty of Medicine and Health Sciences,
Universiti Malaysia Sarawak,
94300 Kota Samarahan,
Sarawak, Malaysia
+6082-267666
Nil
afazilaramli@gmail.com
Nil
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results