Perinatal Mental HealthNCT06040359
Pilot Evaluation of the Thriving Mamas Programme
A study testing The Thriving Mamas programme in people with Perinatal Mental Health, run by King's College London at 2 sites in 2 countries.
Trial summary
The goal of this pilot study is to evaluate the feasibility, appropriateness, and acceptability of a mental health prevention intervention among adolescents during pregnancy and the year after birth (perinatal period) in Kenya and Mozambique. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perinatal Mental Health
- What is being tested?
- The Thriving Mamas programme
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2023to 15 Sep 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mentor mothers: (A) aged 20 years or older; (B) female; (C) experience of pregnancy and/or parenting; and (D) live within the study site
- Adolescent girls: (A) up to 28 weeks pregnant; and (B) aged 15-19 years
- Friends/family members: (A) identified by an adolescent or young woman participating in the study; (B) participation agreed by other participating girls; and (C) aged 18 years or older
Who cannot join
- Mentor mothers will be excluded from participating if they are unable to attend training or deliver the intervention sessions
- Adolescent girls will be excluded from the study if they are unable to provide informed consent or are unable to participate in the intervention, due to existing health conditions
- Friends/family members will not be excluded so long as they meet inclusion criteria
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Mozambique1 site
Centro Internacional para Saude Reprodutiva Mocambique
Maputo
About this study
Official title: Pilot Evaluation of the Thriving Mamas Programme for Adolescent Perinatal Mental Health
The goal of this pilot study is to evaluate the feasibility, appropriateness, and acceptability of a mental health prevention intervention among adolescents during pregnancy and the year after birth (perinatal period) in Kenya and Mozambique. The main questions it aims to answer are:
- Is the intervention feasible, acceptable, appropriate, and delivered/received with high fidelity, to adolescent girls, their friends/family members and service providers?
- Are the implementation strategies acceptable, appropriate, feasible to all relevant stakeholders?
- What impact does the intervention have on adolescent mothers' mental health?
- What impact does the intervention have on adolescent mothers' social, economic, and education outcomes?
Read more
Participants will:
- Participate in nine individual and group sessions focused on improving mental and perinatal health literacy and increasing life skills
- Receive standard perinatal care
Researchers will compare findings with girls receiving standard perinatal care only to see if the intervention has an impact on adolescents' mental health, social, economic and education outcomes.
- Conditions
- Perinatal Mental Health
- Being tested
- The Thriving Mamas programme, Usual care
- Keywords
- Adolescent mental health, Maternal mental health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Thriving Mamas programmeOther
Enhanced antenatal course plus usual perinatal care
Usual careOther
Usual perinatal care
| Study group | Role | What they receive |
|---|---|---|
| Thriving Mama programme | Experimental | Nine meetings delivered in either group (5 meetings), individual (1 meeting), or family group (2 meetings) formats over 10 weeks with an additional individual meeting 10-12 weeks postpartum by a trained mother in the community. Each meeting focuses on the girl's physical and mental health, taking care of a newborn, life skills, future-planning and social support and community-based services. Meetings will take place in a mixture of private settings in health facilities, community facilities, and participant homes. Adolescents will also receive usual perinatal care. Receives: Other: The Thriving Mamas programme |
| Usual perinatal care | Active comparator | Each visit includes care that is appropriate to the overall condition and stage of pregnancy and should include four main categories of care:
1. Identification of pre-existing health conditions (e.g., check for weight and nutrition status, anemia, hypertension, syphilis, HIV status);
2. Early detection of complications arising during pregnancy (e.g., check for pre-eclampsia, gestational diabetes);
3. Health promotion and disease prevention (e.g., tetanus vaccine, prevention and treatment of malaria, nutrition counseling, micronutrient supplements, family planning counseling); and
4. Birth preparedness and complication planning (e.g., birth and emergency plan, breastfeeding counseling, antiretrovirals for HIV positive women and reducing mother-to- child transmission of HIV) Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Feasibility of Intervention Measure (FIM); Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better
Measured: 10-12 weeks post-partum
Intervention Acceptability
Acceptability of Intervention Measure (AIM); Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better
Measured: 10-12 weeks post-partum
Intervention Appropriateness
Intervention Appropriateness Measure (IAM); Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better
Measured: 10-12 weeks post-partum
Intervention Fidelity
Enhancing Assessment of Common Therapeutic Factors (ENACT); subjective report of provider fidelity and perception of care; Minimum=0; Maximum=13; higher score is better
Measured: Through intervention delivery, an average of 24 weeks
Secondary outcomes (21)
Training Feasibility
Feasibility of Intervention Measure (FIM); Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better
Measured: Immediately after provider training
Training Acceptability
Acceptability of Intervention Measure (AIM); Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better
Measured: Immediately after provider training
Training Appropriateness
Intervention Appropriateness Measure (IAM); Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better
Measured: Immediately after provider training
Knowledge
Study-specific measure of mentor mothers' knowledge of issues regarding pregnancy, childbirth, caregiving, mental health, and referral pathways will be assessed using a study-specific quiz based upon the intervention manual; Minimum=0, Maximum=16; higher score is better
Measured: Baseline and immediately after provider training
Change in mental health attitudes
Social Distance Scale (SDS); The SDS measures the acceptability of different degrees of social distance and, by inference, the attitude of the respondent to the person with the condition; Minimum=1, Maximum=96; higher score is better
Measured: Baseline and immediately after provider training
Change in adolescent pregnancy attitudes
Study-specific attitudes towards adolescent pregnancy survey; Minimum=4, Maximum=20; lower score is better
Measured: Baseline and immediately after provider training
Provider competency
Study-specific single 10-point scale to assess provider ability to deliver the intervention; Minimum=0, Maximum=10; higher score is better
Measured: Immediately after provider training
Recruitment rate
Proportion of adolescents providing consent to participate in the study
Measured: pre-intervention
Cost of intervention
Total and average cost of the intervention per participant
Measured: through study completion, an average of 24 weeks
Change in adolescent depression
Patient Health Questionnaire (PHQ-9); Nine-item screening tool which assesses depression symptoms according to clinical criteria. Minimum=0, Maximum=27. A score ≥10 indicates moderate to severe depression.
Measured: through study completion, an average of 24 weeks
Change in adolescent anxiety
Generalised Anxiety Disorder scale (GAD-7); Seven-item screening tool which assesses anxiety symptoms according to clinical criteria. Minimum=0, Maximum=21. A score ≥10 indicates moderate to severe anxiety.
Measured: through study completion, an average of 24 weeks
Change in adolescent quality of life
WHO Quality of Life brief version (WHOQOL-BREF); 26-item scale assesses a respondent's perceived quality of life across four domains: physical health; psychological; social relationships; and environment. Total minimum=25, Total maximum=125. Higher scores indicate greater quality of life in a particular domain.
Measured: through study completion, an average of 24 weeks
Change in adolescent social support
Multidimensional Scale of Perceived Social Support (MSPSS); The MSPSS is a 12-item scale which measures social support from family, friends and significant others. Minimum=12, Maximum=84. Higher scores indicate greater social support.
Measured: through study completion, an average of 24 weeks
Adolescent parenting competency
Parenting Sense of Competency Scale; 17-item scale to measure adolescents' perceived parenting abilities. Minimum=17, Maximum=102. Higher scores indicate greater perceived competence.
Measured: through study completion, an average of 24 weeks
Perinatal appointment attendance
Number of participants attending antenatal appointments
Measured: through study completion, an average of 24 weeks
Referral uptake
Proportion of adolescents attending referral appointments
Measured: 10-12 weeks post-partum
Change in infant vaccination
Number of participants intending to or having had their babies vaccinated
Measured: Baseline and 10-12 weeks post-partum
Change in breastfeeding
Number of participants intendng to or are currently breastfeeding
Measured: Baseline and 10-12 weeks post-partum
Change in intended time to next pregnancy
Study-specific health behaviours questionnaire to assess intended or actual contraceptive Nuimber of participants that want more children who intend to wait at least 15 months before next pregnancy
Measured: Baseline and 10-12 weeks post-partum
Change in contraceptive use
Number of participants intending to or currently using contraceptives to delay pregnancy
Measured: Baseline and 10-12 weeks post-partum
Change in perception of intervention
Study-specific five-item measure assessing knowledge gained, interest in intervention, and support recieved; Minimum=0; Maximum=5; higher score is better
Measured: Baseline and 10-12 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Oct 2023
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal Mental HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Centro Internacional para Saude Reprodutiva Mocambique, UK Research and Innovation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040359
- Sponsor's protocol ID
- HR/DP-22/23-39521
- Status last verified
- Jan 2025
- First submitted
- 23 Aug 2023
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Taylor Salisbury T, Maguele MSB, Chissale F, de Melo M, Hanselmann M, Lamahewa K, Lang'at E, Mandlate F, Nyaga L, Seward N, Temmerman M. Supporting the mental health of adolescent mothers in Kenya and Mozambique: pilot protocol for the Thriving Mamas programme. Pilot Feasibility Stud. 2025 Jun 19;11(1):83. doi: 10.1186/s40814-025-01617-5.
PubMed 40537871
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Thriving Mamas Programme for Adolescent Perinatal Mental Health
- ClinicalTrials.gov ID
- NCT06040359
- Acronym / sponsor ID
- HR/DP-22/23-39521
- Conditions
- Perinatal Mental Health
- Keywords
- Adolescent mental health, Maternal mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Aga Khan University, Centro Internacional para Saude Reprodutiva Mocambique, UK Research and Innovation
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 15 Sep 2023 (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 pilot study is to evaluate the feasibility, appropriateness, and acceptability of a mental health prevention intervention among adolescents during pregnancy and the year after birth (perinatal period) in Kenya and Mozambique. The main questions it aims to answer are:
- Is the intervention feasible, acceptable, appropriate, and delivered/received with high fidelity, to adolescent girls, their friends/family members and service providers?
- Are the implementation strategies acceptable, appropriate, feasible to all relevant stakeholders?
- What impact does the intervention have on adolescent mothers' mental health?
- What impact does the intervention have on adolescent mothers' social, economic, and education outcomes?
Participants will:
- Participate in nine individual and group sessions focused on improving mental and perinatal health literacy and increasing life skills
- Receive standard perinatal care
Researchers will compare findings with girls receiving standard perinatal care only to see if the intervention has an impact on adolescents' mental health, social, economic and education outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thriving Mama programme | Experimental | Other: The Thriving Mamas programmeNine meetings delivered in either group (5 meetings), individual (1 meeting), or family group (2 meetings) formats over 10 weeks with an additional individual meeting 10-12 weeks postpartum by a trained mother in the community. Each meeting focuses on the girl's physical and mental health, taking care of a newborn, life skills, future-planning and social support and community-based services. Meetings will take place in a mixture of private settings in health facilities, community facilities, and participant homes. Adolescents will also receive usual perinatal care. |
| Usual perinatal care | Active comparator | Other: Usual careEach visit includes care that is appropriate to the overall condition and stage of pregnancy and should include four main categories of care: 1. Identification of pre-existing health conditions (e.g., check for weight and nutrition status, anemia, hypertension, syphilis, HIV status); 2. Early detection of complications arising during pregnancy (e.g., check for pre-eclampsia, gestational diabetes); 3. Health promotion and disease prevention (e.g., tetanus vaccine, prevention and treatment of malaria, nutrition counseling, micronutrient supplements, family planning counseling); and 4. Birth preparedness and complication planning (e.g., birth and emergency plan, breastfeeding counseling, antiretrovirals for HIV positive women and reducing mother-to- child transmission of HIV) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mentor mothers: (A) aged 20 years or older; (B) female; (C) experience of pregnancy and/or parenting; and (D) live within the study site
- Adolescent girls: (A) up to 28 weeks pregnant; and (B) aged 15-19 years
- Friends/family members: (A) identified by an adolescent or young woman participating in the study; (B) participation agreed by other participating girls; and (C) aged 18 years or older
Key exclusion criteria (3 listed)
- Mentor mothers will be excluded from participating if they are unable to attend training or deliver the intervention sessions
- Adolescent girls will be excluded from the study if they are unable to provide informed consent or are unable to participate in the intervention, due to existing health conditions
- Friends/family members will not be excluded so long as they meet inclusion criteria
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 |
|---|---|---|
| The Thriving Mamas programmeEnhanced antenatal course plus usual perinatal care | Other | Thriving Mama programme |
| Usual careUsual perinatal care | Other | Usual perinatal care |
Primary outcome
Intervention Feasibility
Time frame: 10-12 weeks post-partum
Feasibility of Intervention Measure (FIM); Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better
Intervention Acceptability
Time frame: 10-12 weeks post-partum
Acceptability of Intervention Measure (AIM); Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better
Intervention Appropriateness
Time frame: 10-12 weeks post-partum
Intervention Appropriateness Measure (IAM); Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better
Intervention Fidelity
Time frame: Through intervention delivery, an average of 24 weeks
Enhancing Assessment of Common Therapeutic Factors (ENACT); subjective report of provider fidelity and perception of care; Minimum=0; Maximum=13; higher score is better
21 secondary outcomes
Training Feasibility
Time frame: Immediately after provider training
Training Acceptability
Time frame: Immediately after provider training
Training Appropriateness
Time frame: Immediately after provider training
Knowledge
Time frame: Baseline and immediately after provider training
Change in mental health attitudes
Time frame: Baseline and immediately after provider training
Change in adolescent pregnancy attitudes
Time frame: Baseline and immediately after provider training
Provider competency
Time frame: Immediately after provider training
Recruitment rate
Time frame: pre-intervention
Cost of intervention
Time frame: through study completion, an average of 24 weeks
Change in adolescent depression
Time frame: through study completion, an average of 24 weeks
Change in adolescent anxiety
Time frame: through study completion, an average of 24 weeks
Change in adolescent quality of life
Time frame: through study completion, an average of 24 weeks
Change in adolescent social support
Time frame: through study completion, an average of 24 weeks
Adolescent parenting competency
Time frame: through study completion, an average of 24 weeks
Perinatal appointment attendance
Time frame: through study completion, an average of 24 weeks
Referral uptake
Time frame: 10-12 weeks post-partum
Change in infant vaccination
Time frame: Baseline and 10-12 weeks post-partum
Change in breastfeeding
Time frame: Baseline and 10-12 weeks post-partum
Change in intended time to next pregnancy
Time frame: Baseline and 10-12 weeks post-partum
Change in contraceptive use
Time frame: Baseline and 10-12 weeks post-partum
Change in perception of intervention
Time frame: Baseline and 10-12 weeks post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Derived from this study: PubMed 40537871Taylor Salisbury T, Maguele MSB, Chissale F, de Melo M, Hanselmann M, Lamahewa K, Lang'at E, Mandlate F, Nyaga L, Seward N, Temmerman M. Supporting the mental health of adolescent mothers in Kenya and Mozambique: pilot protocol for the Thriving Mamas programme. Pilot Feasibility Stud. 2025 Jun 19;11(1):83. doi: 10.1186/s40814-025-01617-5.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Thriving Mamas programme in people with Perinatal Mental Health, run by King's College London at 2 sites in 2 countries.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jan 2025. 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 Kenya, Mozambique. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: 10-12 weeks post-partum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040359, which also lists 1 linked publication.
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 16 Jan 2025.