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

Not Applicable

Active, not recruiting

• Conditions: Depression Disorders

• Registration Number: NCT06740084
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)	Feasibility of the intervention will be measured using the 'Feasibility of Intervention Measure' (FIM) with adolescents who received the Y-MIND intervention.
Symptoms of depression	5 months post baseline assessment	Symptoms of depression at 5 months post baseline assessment measured as the difference in mean score on the Patient Health Questionnaire-9 (PHQ-9) between the two arms. Difference in mean PHQ-9 would likely constitute a primary outcome in a later larger definitive trial.

Secondary Outcome Measures

Name	Time	Method
Acceptability and appropriateness of the intervention	At end of Y-MIND intervention sessions or at 5 months post baseline assessment	Acceptability and appropriateness of the intervention will be measured using the Intervention Appropriateness Measure (IAM), Acceptability of Intervention Measure (AIM) with adolescents at the end of their last intervention session (or at their 5 month post baseline assessment if the intervention session was not attended), and with Guidance and Counselling Coordinators at schools after they have finished delivering all intervention sessions.; Acceptability will also be explored through interviews with adolescents (at end of 5 months post baseline assessment) and focus group discussions with Guidance and Counselling Coordinators (after they have finished delivering all intervention sessions) to elicit feasibility, acceptability, appropriateness and barriers and or enablers that may influence the effectiveness of the intervention.
Feasibility of the intervention (Guidance and Counselling Coordinators)	At the end of treatment delivery	Feasibility of the intervention from the perspective of the Guidance and Counselling Coordinators, will also be measured using the Feasibility of Intervention Measure (FIM) with Guidance and Counselling Coordinators.
Fidelity to delivering the psychological intervention	From the first treatment session (week 1) to the end of treatment (week 6)	Fidelity to delivering the psychological intervention, defined as the extent to which the intervention was delivered as intended, and measured by rating 20% of randomly selected audio-recorded psychological intervention sessions in the experimental arm using a culturally adapted form of ENACT called the 'Problem-Solving Therapy Fidelity Scale (PROOF)' tool.
Symptoms of anxiety	5 months post baseline assessment	Symptoms of anxiety at 5 months post baseline assessment measured as the difference in mean score on the General Anxiety Disorder scale (GAD-7) between the two arms.
Alcohol use	5 months post baseline assessment	Alcohol use measured as the difference in mean score on the Alcohol Use Disorders Identification Test (AUDIT)

Trial Locations

Locations (1)

Navrongo Health Research Centre; 🇬🇭 Navrongo, Ghana