Pilot Evaluation of the Thriving Mamas Programme

• ClinicalTrials.gov Identifier: NCT06040359
• Recruitment Status: Not yet recruiting
• First Posted: September 15, 2023
• Last Update Posted: September 15, 2023
• Sponsor: King's College London
• Collaborators: Aga Khan University; Centro Internacional para Saude Reprodutiva Mocambique; UK Research and Innovation
• Information provided by (Responsible Party): King's College London

Tracking Information

• First Submitted Date: August 23, 2023
• First Posted Date: September 15, 2023
• Last Update Posted Date: September 15, 2023
• Estimated Study Start Date: September 2023
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2023)

• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 13, 2023)

• Training Feasibility [ Time Frame: Immediately after provider training ]
  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
• Training Acceptability [ Time Frame: Immediately after provider training ]
  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
• Training Appropriateness [ Time Frame: Immediately after provider training ]
  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
• Knowledge [ Time Frame: Baseline and immediately after provider training ]
  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
• Change in mental health attitudes [ Time Frame: Baseline and immediately after provider training ]
  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
• Change in adolescent pregnancy attitudes [ Time Frame: Baseline and immediately after provider training ]
  Study-specific attitudes towards adolescent pregnancy survey; Minimum=4, Maximum=20; lower score is better
• Provider competency [ Time Frame: Immediately after provider training ]
  Study-specific single 10-point scale to assess provider ability to deliver the intervention; Minimum=0, Maximum=10; higher score is better
• Recruitment rate [ Time Frame: pre-intervention ]
  Proportion of adolescents providing consent to participate in the study
• Cost of intervention [ Time Frame: through study completion, an average of 24 weeks ]
  Total and average cost of the intervention per participant
• Change in adolescent depression [ Time Frame: through study completion, an average of 24 weeks ]
  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.
• Change in adolescent anxiety [ Time Frame: through study completion, an average of 24 weeks ]
  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.
• Change in adolescent quality of life [ Time Frame: through study completion, an average of 24 weeks ]
  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.
• Change in adolescent social support [ Time Frame: through study completion, an average of 24 weeks ]
  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.
• Adolescent parenting competency [ Time Frame: through study completion, an average of 24 weeks ]
  Parenting Sense of Competency Scale; 17-item scale to measure adolescents' perceived parenting abilities. Minimum=17, Maximum=102. Higher scores indicate greater perceived competence.
• Perinatal appointment attendance [ Time Frame: through study completion, an average of 24 weeks ]
  Number of participants attending antenatal appointments
• Referral uptake [ Time Frame: 10-12 weeks post-partum ]
  Proportion of adolescents attending referral appointments
• Change in infant vaccination [ Time Frame: Baseline and 10-12 weeks post-partum ]
  Number of participants intending to or having had their babies vaccinated
• Change in breastfeeding [ Time Frame: Baseline and 10-12 weeks post-partum ]
  Number of participants intendng to or are currently breastfeeding
• Change in intended time to next pregnancy [ Time Frame: Baseline and 10-12 weeks post-partum ]
  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
• Change in contraceptive use [ Time Frame: Baseline and 10-12 weeks post-partum ]
  Number of participants intending to or currently using contraceptives to delay pregnancy
• Change in perception of intervention [ Time Frame: Baseline and 10-12 weeks post-partum ]
  Study-specific five-item measure assessing knowledge gained, interest in intervention, and support recieved; Minimum=0; Maximum=5; higher score is better

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Evaluation of the Thriving Mamas Programme
• Official Title: Pilot Evaluation of the Thriving Mamas Programme for Adolescent Perinatal Mental Health

Brief 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. 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Perinatal Mental Health

Intervention

• Other: The Thriving Mamas programme
  Enhanced antenatal course plus usual perinatal care
• Other: Usual care
  Usual perinatal care

Study Arms

• Experimental: Thriving Mama programme
  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.
  Intervention: Other: The Thriving Mamas programme
• Active Comparator: Usual perinatal care

  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)
  Intervention: Other: Usual care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 13, 2023): 156
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Tatiana Salisbury; +44(0)20 7848 85107; tatiana.salisbury@kcl.ac.uk

• Listed Location Countries: Kenya, Mozambique

Administrative Information

• NCT Number: NCT06040359
• Other Study ID Numbers: HR/DP-22/23-39521
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: King's College London
• Original Responsible Party: Same as current
• Current Study Sponsor: King's College London
• Original Study Sponsor: Same as current

Collaborators

• Aga Khan University
• Centro Internacional para Saude Reprodutiva Mocambique
• UK Research and Innovation

• Investigators: Not Provided
• PRS Account: King's College London
• Verification Date: August 2023