Pilot Evaluation of the Thriving Mamas Programme

Perinatal Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06040359
• Other study ID #: HR/DP-22/23-39521
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: King's College London
• Contact: Tatiana Salisbury
• Phone: +44(0)20 7848 85107
• Email: tatiana.salisbury[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perinatal Mental Health

Intervention

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

Locations

Country	Name	City	State
Kenya	Aga Khan University	Nairobi
Mozambique	Centro Internacional para Saude Reprodutiva Mocambique	Maputo

Sponsors (4)

Lead Sponsor	Collaborator
King's College London	Aga Khan University, Centro Internacional para Saude Reprodutiva Mocambique, UK Research and Innovation

Countries where clinical trial is conducted

Kenya,  Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10-12 weeks post-partum
Primary	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	10-12 weeks post-partum
Primary	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	10-12 weeks post-partum
Primary	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	Through intervention delivery, an average of 24 weeks
Secondary	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	Immediately after provider training
Secondary	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	Immediately after provider training
Secondary	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	Immediately after provider training
Secondary	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	Baseline and immediately after provider training
Secondary	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	Baseline and immediately after provider training
Secondary	Change in adolescent pregnancy attitudes	Study-specific attitudes towards adolescent pregnancy survey; Minimum=4, Maximum=20; lower score is better	Baseline and immediately after provider training
Secondary	Provider competency	Study-specific single 10-point scale to assess provider ability to deliver the intervention; Minimum=0, Maximum=10; higher score is better	Immediately after provider training
Secondary	Recruitment rate	Proportion of adolescents providing consent to participate in the study	pre-intervention
Secondary	Cost of intervention	Total and average cost of the intervention per participant	through study completion, an average of 24 weeks
Secondary	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.	through study completion, an average of 24 weeks
Secondary	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.	through study completion, an average of 24 weeks
Secondary	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.	through study completion, an average of 24 weeks
Secondary	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.	through study completion, an average of 24 weeks
Secondary	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.	through study completion, an average of 24 weeks
Secondary	Perinatal appointment attendance	Number of participants attending antenatal appointments	through study completion, an average of 24 weeks
Secondary	Referral uptake	Proportion of adolescents attending referral appointments	10-12 weeks post-partum
Secondary	Change in infant vaccination	Number of participants intending to or having had their babies vaccinated	Baseline and 10-12 weeks post-partum
Secondary	Change in breastfeeding	Number of participants intendng to or are currently breastfeeding	Baseline and 10-12 weeks post-partum
Secondary	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	Baseline and 10-12 weeks post-partum
Secondary	Change in contraceptive use	Number of participants intending to or currently using contraceptives to delay pregnancy	Baseline and 10-12 weeks post-partum
Secondary	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	Baseline and 10-12 weeks post-partum