Help-Seeking BehaviorADHS-RCTNCT06390735
Antenatal Depression Help-seeking Trial in Eswatini
A study testing Mommy ReachOut Intervention in people with Help-Seeking Behavior and Help-seeking Intention, run by Taipei Medical University at 2 sites in Eswatini.
Trial summary
The goal of this trial to test if a web-based psychoeducation will work in improving depression help-seeking intention and behavior among antenatal women with probable depression in Eswatini. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Help-Seeking Behavior, Help-seeking Intention, Antenatal Depression
- What is being tested?
- Mommy ReachOut Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesEswatini
- Study dates
- 25 Mar 2024to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Less than 30 weeks of gestation,
- Aged 18 or above
- With probable depression (Edinburg Postnatal depression scale; EPDS > 10)
- Has access to a smart phone
- Fluent in spoken and written Siswati or English (with at least secondary school education)
- Planning to remain in the country for the next 2 months
- Willing to share her dominant phone number with the study team
- Willing to participate in the intervention study
Who cannot join
- Antidepressants or other depression treatments
- Currently enrolled in another trial
Trial locations and contacts
2 sites in 1 country.
Min-Huey Chung, PhD contact
Eswatini2 sites, 2 recruiting
- Recruiting
King Sobhuza II Public Health Unit
Manzini
Lindelwa P. Dlamini, MSc., +268 78369828, ndedlamini@gmail.com
- Recruiting
Mbabane Government Public Health Unit
Mbabane, Hhohho Region, H001
Lindelwa P. Dlamini, MSc, +268 78369828, ndedlamini@gmail.com
About this study
Official title: Effectiveness of a Web-based Psychoeducation on Antenatal Depression Help-seeking in Eswatini
The goal of this trial to test if a web-based psychoeducation will work in improving depression help-seeking intention and behavior among antenatal women with probable depression in Eswatini. The main question it aims to answer is:
- Does the web-based psychoeducation improve depression help-seeking intention and help-seeking behavior in antenatal women with probable depressive symptoms?
Read more
Researchers will compare this web-based psychoeducation to a waitlist control, to see if the program works in improving depression help-seeking intention and behavior during pregnancy.
- The psychoeducation program will have a total of 4 sessions, which will be given to participants over a two-week period. two sessions will be delivered each week.
- Participants will be asked questions before the intervention starts, immediately the intervention ends as well as after a month of completing the intervention.
- Being tested
- Mommy ReachOut Intervention
- Keywords
- antenatal depression, Web-based interventions, Psychoeducation, RCT, Eswatini, Help-seeking
- Medical subject headings
- Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mommy ReachOut InterventionBehavioural
The momy reachOut intervention is a web-based psycho-education with 4 sessions, released over a two week period.
| Study group | Role | What they receive |
|---|---|---|
| Mommy ReachOut intervention | Experimental | The intervention group will receive the Mommy ReachOut intervention, which is a web-based psychoeducation, consisting of a total of 4 sessions to be released over a 2-week period. Two sessions will be released each week, with each session consisting of readable mental health information and videos. Content for this intervention was based on previous reviews, previous intervention studies and the Diagnostic and Statistical manual of mental health disorders (DSM-5). Session content included basic information about antenatal depression, shared antenatal depression experiences, issues around stigma towards antenatal depression, and local resources available for antenatal women with depression in Eswatini. Receives: Behavioral: Mommy ReachOut Intervention |
| waitlist control | No intervention | Participants in the control group will have access to the active treatment after completing the 6-week waiting period. Once the control participants complete the 1-month follow-up assessment, they will receive a website link to access the complete Mommy ReachOut intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Help-seeking Intention
General Help Seeking Questionnaire - This 9 item scale adopted a 3 point Likert scale (Unlikely, maybe, Likely) to measure help-seeking intention. The total score is computed by summing up all item scores, where a higher score indicates higher help-seeking intention. The total possible score ranges from 9 to 27.
Measured: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Help-seeking Behavior
Actual Help Seeking Questionnaire - This 9 item scale uses binary responses (Yes or No) to measure actual help-seeking behavior. The total score is computed by summing up all item scores, where a higher score indicates higher help-seeking behavior. The total possible score ranges from 0 to 9.
Measured: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Secondary outcomes (4)
Antenatal depressive symptoms
Edinburgh Postnatal Depression Scale - A set of 10 items are used to measure antenatal depressive symptoms on a 4-point Likert scale (0-3). The overall score ranges from 0 to 30 and is computed by summing up all item scores. A high sum of scores indicates a high level of depressive symptoms.
Measured: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Health belief
Theory of Planned Behavior questionnaire - The tool has 13 items that rate the constructs of the theory of planned behavior on a 5-point Likert scales (strongly disagree to strongly agree). The possible score ranges from 13 to 65, with higher scores indicating more favorable attitudes towards help-seeking, greater subjective norms to seek help, and more control over one's behavior.
Measured: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Antenatal depression Stigma
Depression stigma scale - The 9 items in this scale measure personal stigma towards depression. Responses to each item are measured on a five-point Likert scale (strongly disagree to strongly agree). The total score is through summing up all item scores and a total possible score ranges from 0 to 36. A higher score indicates higher levels of personal depression stigma
Measured: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Depression literacy
Depression literacy scale - The scale measures participants knowledge of the signs of depression, risk factors, and treatment among others. participants respond to each item with a true (1) or false (0), therefore, the total possible score ranges from 0 to 22. From summing up all item scores, a higher score will indicate high antenatal depression literacy.
Measured: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start25 Mar 2024
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Help-Seeking BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This two armed trial will include an intervention group and a waitlist control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindelwa Portia Dlamini, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390735
- Sponsor's protocol ID
- N202312058
- Other IDs
- EHHRRB 194/2023
- Acronym
- ADHS-RCT
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Web-based Psychoeducation on Antenatal Depression Help-seeking in Eswatini
- ClinicalTrials.gov ID
- NCT06390735
- Acronym / sponsor ID
- ADHS-RCT / N202312058
- Keywords
- antenatal depression, Web-based interventions, Psychoeducation, RCT, Eswatini, Help-seeking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial to test if a web-based psychoeducation will work in improving depression help-seeking intention and behavior among antenatal women with probable depression in Eswatini. The main question it aims to answer is:
- Does the web-based psychoeducation improve depression help-seeking intention and help-seeking behavior in antenatal women with probable depressive symptoms?
Researchers will compare this web-based psychoeducation to a waitlist control, to see if the program works in improving depression help-seeking intention and behavior during pregnancy.
- The psychoeducation program will have a total of 4 sessions, which will be given to participants over a two-week period. two sessions will be delivered each week.
- Participants will be asked questions before the intervention starts, immediately the intervention ends as well as after a month of completing the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This two armed trial will include an intervention group and a waitlist control group.
| Arm | Type | Receives |
|---|---|---|
| Mommy ReachOut intervention | Experimental | Behavioral: Mommy ReachOut InterventionThe intervention group will receive the Mommy ReachOut intervention, which is a web-based psychoeducation, consisting of a total of 4 sessions to be released over a 2-week period. Two sessions will be released each week, with each session consisting of readable mental health information and videos. Content for this intervention was based on previous reviews, previous intervention studies and the Diagnostic and Statistical manual of mental health disorders (DSM-5). Session content included basic information about antenatal depression, shared antenatal depression experiences, issues around stigma towards antenatal depression, and local resources available for antenatal women with depression in Eswatini. |
| waitlist control | No intervention | –Participants in the control group will have access to the active treatment after completing the 6-week waiting period. Once the control participants complete the 1-month follow-up assessment, they will receive a website link to access the complete Mommy ReachOut intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Less than 30 weeks of gestation,
- Aged 18 or above
- With probable depression (Edinburg Postnatal depression scale; EPDS > 10)
- Has access to a smart phone
- Fluent in spoken and written Siswati or English (with at least secondary school education)
Key exclusion criteria (2 listed)
- Antidepressants or other depression treatments
- Currently enrolled in another trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mommy ReachOut InterventionThe momy reachOut intervention is a web-based psycho-education with 4 sessions, released over a two week period. | Behavioural | Mommy ReachOut intervention |
Primary outcome
Help-seeking Intention
Time frame: Baseline; Immediately post intervention; follow-up at 1 month post intervention
General Help Seeking Questionnaire - This 9 item scale adopted a 3 point Likert scale (Unlikely, maybe, Likely) to measure help-seeking intention. The total score is computed by summing up all item scores, where a higher score indicates higher help-seeking intention. The total possible score ranges from 9 to 27.
Help-seeking Behavior
Time frame: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Actual Help Seeking Questionnaire - This 9 item scale uses binary responses (Yes or No) to measure actual help-seeking behavior. The total score is computed by summing up all item scores, where a higher score indicates higher help-seeking behavior. The total possible score ranges from 0 to 9.
4 secondary outcomes
Antenatal depressive symptoms
Time frame: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Health belief
Time frame: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Antenatal depression Stigma
Time frame: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Depression literacy
Time frame: Baseline; Immediately post intervention; follow-up at 1 month post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Huey Chung, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mommy ReachOut Intervention in people with Help-Seeking Behavior and Help-seeking Intention, run by Taipei Medical University at 2 sites in Eswatini.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindelwa Portia Dlamini, MSc (+268 78369828, ndedlamini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Help-seeking Intention (time frame: Baseline; Immediately post intervention; follow-up at 1 month post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.