Hybrid Health Education Intervention Integrated Within a Mental Health Package for Adolescent Perinatal Depression

NCT06154655 | Unknown

• 1 other identifier: K43TW011046
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to develop a hybrid E-zine health education intervention integrated within a mental Health package for adolescent perinatal depression. The main objective is to:

• Develop a hybrid Health Educational Intervention offering health promotion and disease prevention services on climate change to perinatal adolescents and their caregivers.
• Study the feasibility, acceptability, and usability of E-zineMH in a pilot trial among perinatal adolescents and their caregivers in comparison to a control arm that delivers face-to-face health education in routine antenatal clinics. Participants will be expected to attend routine antenatal appointments for the duration of the study. In addition to the face-to-face health education delivered to both groups, the intervention group will be exposed to e-magazines on climate change.

Conditions

Perinatal Depression

Keywords

Climate change; Adolescent mental health; Perinatal depression; Health education; Digital health

Outcome Measures

Primary Outcomes (2)

• Edinburgh Postnatal Depression Scale (EPDS)

  The Edinburgh Postnatal Depression Scale (EPDS) is a screening tool for perinatal depression. The cut off for depression is a score equal or greater than 12 point.

  Baseline

• Edinburgh Postnatal Depression Scale (EPDS)

  The Edinburgh Postnatal Depression Scale (EPDS) is a screening tool for perinatal depression. The cut off for depression is a score equal or greater than 12 point.

  Four months after baseline

Secondary Outcomes (4)

• WHO Disability Assessment Schedule (WHODAS 2.0)

  Baseline

• WHO Disability Assessment Schedule (WHODAS 2.0)

  Four months after baseline

• General Health Questionnaire - 28 (GHQ-28)

  Baseline

• General Health Questionnaire - 28 (GHQ-28)

  Four months after baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

participants will receive health education on climate change included in their routine antenatal care and also have access to the e-magazine accessible through mobile phones

Other: E-zine

Control Group

NO INTERVENTION

participants will receive health education on climate change included in their routine antenatal care

Interventions

E-zine OTHER

Health education will be delivered through an electronic magazine

Intervention Group

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Perinatal adolescents aged 16-21 years and below Participants would live in the study area for the 4 months of study participation.
• Participants provide informed consent.

You may not qualify if:

• Patients needing immediate medical attention Patients that would not be available in the neighborhood for up to 4 months duration in the study

Sponsors & Collaborators

• University of Ibadan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Abaemu Primary Health Care Center

Ibadan, Oyo State, Nigeria

RECRUITING

Oranyan Primary Health care centre

Ibadan, Oyo State, Nigeria

RECRUITING

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lola Kola, PhD

  College of Medicine University of Ibadan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobi Fatodu, MPH

CONTACT

+2348134002671; tobifatodu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessment will be carried at four months post baseline by 2 outcome assessors blind to study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A pilot trial will be conducted with 60 perinatal adolescents (30 in the E-zineMH arm and 30 in the control arm). Participants will be assigned to each arms at the beginning of the trial and continue in that arm throughout the trial. Two clinics, with wide geographic seperation will be used in the study. One of the clinics will serve as the intervention clinic and the other will serve as control.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: December 4, 2023
• Study Start: August 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

NG (2)