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Table 4 Research implementation steps and data gathering activities

From: Implementing combined WHO mhGAP and adapted group interpersonal psychotherapy to address depression and mental health needs of pregnant adolescents in Kenyan primary health care settings (INSPIRE): a study protocol for pilot feasibility trial of the integrated intervention in LMIC settings

Research Implementation steps and data gathering activities

Protocol development, pre-testing of tools and training; formation of technical and community advisory boards

Mixed qualitative methods inquiry on facilitators and barriers to uptake of evidence- based interventions for depression care in primary care settings for pregnant adolescents

Adaptation of mhGAP depression care guidelines and treatment intervention for pregnant adolescents

Observational notes for clinical workflow in primary care and training in integrated mhGAP and IPT-G for depression care

Adaptation of brief IPT-G

Test feasibility of implementation and estimate the size of effect on mental health for the adapted version of mhGAP-IG/ IPT-G.

Analyses, writing and dissemination

Sample

Community advisory (17members),

Technical advisory board (5 members)

40 participants (8 FGDs with 5 members per group),

Utilizing community advisory and technical advisory boards for adaptation process; expert consultation as and where needed

20 researchers and 16 providers

Utilizing community advisory and technical advisory boards for adaptation process; expert consultation as and where needed

90 pregnant adolescents in a three-arm study: IPT-G Full and IPT-G Mini

Compiling all the information derived from all participants and consultations with mentors, experts and advisory board members

Location of activity

In person and virtual meetings with study team members and mentors

Community and health facility based

Desk-based activity including expert consultation with partners from Department of Psychiatry University of Nairobi, Department of Mental Health MoH, WHO, UNFPA and Nairobi county

Community and health facility sample

Community and health facility sample

Community and health facility -based purposive sampling

Virtual, in-person one-on-one and group discussions and meetings with research team, advisory board members and mentors

Training of health workers and capacity building activities

Train two-four career researchers, engage communities and build networks with Ministry of Health, mapping a referrals process for any medical or psychosocial issue arising during study

Train data collectors & RAs in two sites, train teams in psychological first aid, identify community health workers for linkages in case of any referrals for those with high depression or at risk for mental or physical

Collaborative work with the research team; three early career researchers and postgraduate students trained in mhGAP and IPT-G; technical and community advisory

Collaborative work with research team, trained researchers to train health facility workers and community health workers; capacity building of the health facility nurses in depression screening for adolescents especially peripartum

Collaborative work with the research team; trained health facility and community providers; technical and community advisory and mentors

Trained data collectors from Aim 1 would be re-engaged and additional trainings and capacity building on survey data collection will be carried out before the survey is collected. Quality assurance checks will be carried out after first 5 participant survey data per site and training repeated if there are discrepancies

Dissemination of findings to Ministry of Health and Nairobi County, Training programs for health facility workers with county and ministry of health using mhGAP

Data collection method

Iteratively developed mixed methods inquiry with expert consultation, community advisory support

a. FGDs, KIIs

b. Short survey for conjoint experiment

a. Stakeholder engagement through advisory board meetings and group discussions, b. Expert feedback

a. ethnographic- observational study,

b. training workshops with the researchers,

c. training workshops in the health facilities

a. Stakeholder engagement through advisory board meetings and group discussions,

b. Expert feedback

feasibility trial with individual level randomization- Intervention will be delivered in groups at the health facility and data would be collected during each session and after session

Mixed methods analysis: psychometrics/multivariate analyses/ mixed qual methods

Domains addressed /focal activities

Comprehensive community based participatory approach integrating strengths and needs of key partners from Ministry of Health, Nairobi County, WHO and UNFPA

Depression care needs from multiple stakeholders; depression care treatment preferences

Adaptations and modifications for WHO mhGAP depression treatment manual and IPT-G manual for peripartum adolescents

Integrated work-flow plan to address mental health needs of pregnant adolescents

Brief version of IPT-G which has been validated for use by technical and community advisory

Multilevel assessments from participants, providers and facility managers on acceptability, appropriateness, and usefulness of the adapted version and implementation process of the mhGAP-IG/ IPT-G service model; and adolescent self- report depression and functioning outcomes;

Several planned publications including: a. mhGAP/IPT-G adaptation for adolescent mothers with depression;

b. Acceptability and Appropriateness of the Brief and Long versions of IPT-G intervention implemented by CHWs (results from a mixed method study),

c. D&I context measures validation paper,

d. Implementation Effectiveness Evaluation (using RCT implementation study data to study effectiveness for brief and long version of IPT-G)

Outcome measure/s or final output

Finalized protocol with all IRB clearances and peer reviewed by a wide group of specialists

Multi-stakeholder appraisal of depression care treatment preferences

Integrated mhGAP depression care with modified IPT-G manual

New workflow plan to organize clinical services around mental health care for pregnant adolescents

Finalized version of the manual

Acceptable and useful integrated mhGAP depression care and modified IPT-G for adolescents, health facility and community health workers. Evidence of small to moderate size of intervention effect on adolescents. See Tables 1 and 2

Peer reviewed publications, conference presentations, dissemination in the three communities through Ministry of Health and in the scientific community