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Completed

NCT Number: NCT06040359

Pilot Evaluation of the Thriving Mamas Programme

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.

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Key information

Conditions

Perinatal Mental Health

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University, Nairobi, Kenya

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Thriving Mamas programme

Other

Enhanced antenatal course plus usual perinatal care

Usual Care

Other

Usual perinatal care

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Recruitment rate

    Time frame: pre-intervention

    Proportion of adolescents providing consent to participate in the study

  9. Cost of intervention

    Time frame: through study completion, an average of 24 weeks

    Total and average cost of the intervention per participant

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Perinatal appointment attendance

    Time frame: through study completion, an average of 24 weeks

    Number of participants attending antenatal appointments

  16. Referral uptake

    Time frame: 10-12 weeks post-partum

    Proportion of adolescents attending referral appointments

  17. Change in infant vaccination

    Time frame: Baseline and 10-12 weeks post-partum

    Number of participants intending to or having had their babies vaccinated

  18. Change in breastfeeding

    Time frame: Baseline and 10-12 weeks post-partum

    Number of participants intendng to or are currently breastfeeding

  19. 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

  20. 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

  21. 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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

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

Registry information

Official study title

Pilot Evaluation of the Thriving Mamas Programme for Adolescent Perinatal Mental Health

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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