Clinical trial NCT06740084: African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Older Adolescents with Depression Delivered Through Senior High Schools in Navrongo, Ghana
Official title: African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Older Adolescents with Depression Delivered Through Senior High Schools in Navrongo, Ghana
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression Disorders
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Zimbabwe
name: University of Ghana
name: Kamuzu University of Health Sciences
name: Navrongo Health Research Centre, Ghana
First posted: 2024-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching aim of this pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND), delivered by school guidance and counselling coordinators, for the treatment of depression among adolescents in senior high schools in Ghana. The study is a parallel arm cluster randomised controlled pilot trial. We will recruit adolescents aged 15 to 18 years in senior high schools. Participants will be randomised to receive the Y-MIND psychological intervention or enhanced usual care.


Eligibility criteria: Inclusion Criteria:

* Adolescents aged 15 to 18 years in senior high schools located within the Kassena-Nankana Municipality and Kassena-Nankana West District
* Have scored 10 or more on the locally validated Patient Health Questionnaire-9 (PHQ-9)
* be willing and able to be followed up for 5 months and provide informed consent or assent
* For adolescents 15-17 years participants must have 5) access to a caregiver to obtain informed consent
* All participants must have the ability to read, write and communicate in English language.

Exclusion Criteria:

* are currently receiving any psychological treatment (talking therapy) for any common mental disorder through formal health care services
* have active bipolar disorder or psychosis (assessed through a brief screening tool for bipolar disorder and psychosis)
* have advanced or chronic physical illness (assessed through self-report)
* have significant visual or hearing impairment which would interfere with their ability to take part in the study
* are actively suicidal (assessed through the use of a four-item screening tool administered by a psychiatric nurse and reviewed by the trial clinical psychologist

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)
measure: Symptoms of depression
timeFrame: 5 months post baseline assessment
Secondary outcomes:
measure: Acceptability and appropriateness of the intervention
timeFrame: At end of Y-MIND intervention sessions or at 5 months post baseline assessment
measure: Feasibility of the intervention (Guidance and Counselling Coordinators)
timeFrame: At the end of treatment delivery
measure: Fidelity to delivering the psychological intervention
timeFrame: From the first treatment session (week 1) to the end of treatment (week 6)
measure: Symptoms of anxiety
timeFrame: 5 months post baseline assessment
measure: Alcohol use
timeFrame: 5 months post baseline assessment
Other outcomes:
measure: Feasibility of conducting a fully powered trial
timeFrame: Screening to 5 months post baseline assessment
measure: Resource use and cost of the Y-MIND psychological intervention
timeFrame: Baseline to 5 month post baseline assessment
Locations:
city: Navrongo
country: Ghana
facility: Navrongo Health Research Centre
Study officials:
References: