NCT06740084

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2024Aug 2026

Study Start

First participant enrolled

July 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

December 9, 2024

Last Update Submit

March 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the intervention

    Feasibility of the intervention will be measured using the 'Feasibility of Intervention Measure' (FIM) with adolescents who received the Y-MIND intervention.

    At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)

  • Symptoms of depression

    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.

    5 months post baseline assessment

Secondary Outcomes (5)

  • Acceptability and appropriateness of the intervention

    At end of Y-MIND intervention sessions or at 5 months post baseline assessment

  • Feasibility of the intervention (Guidance and Counselling Coordinators)

    At the end of treatment delivery

  • Fidelity to delivering the psychological intervention

    From the first treatment session (week 1) to the end of treatment (week 6)

  • Symptoms of anxiety

    5 months post baseline assessment

  • Alcohol use

    5 months post baseline assessment

Other Outcomes (2)

  • Feasibility of conducting a fully powered trial

    Screening to 5 months post baseline assessment

  • Resource use and cost of the Y-MIND psychological intervention

    Baseline to 5 month post baseline assessment

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

Enhanced Usual Care (EUC): Guidance and counselling coordinators in the schools provide some counselling to students who need it. Building on the existing structure, enhanced usual care in the Y-MIND programme, will be enhanced in three ways 1) Teaching staff will receive basic training on common mental health conditions affecting youth in Ghana with an emphasis on depression and suicidal symptoms and treatment. 2) Nurses in all schools and other relevant local health care professionals will be trained in mental health, substance-use and self-harm including guidelines on when and where to refer young people for psychiatric care. 3) The study team will provide a letter for the Guidance and Counselling Coordinators for the participant.

Other: Enhanced Usual Care

Y-MIND Intervention

EXPERIMENTAL

All participants in the intervention arm will receive the EUC plus the Y-Mind intervention. Y-Mind intervention will be delivered by trained and supervised Guidance and Counselling Coordinators (GCC) at schools in 6 sessions. The six sessions will include a) psychoeducation on depression, b) behavioural activation (helping the participant see the connection between their behaviour, daily activities, and low mood and activity scheduling) and c) problem-solving therapy (the GCC helps the participant identify and define a specific problem to work on, evaluate the potential solutions to the problem, and carry out the selected solution(s)).

Behavioral: Y-MIND Intervention

Interventions

All participants in the intervention arm will receive the EUC plus the Y-Mind intervention. Y-Mind intervention will be delivered by trained and supervised Guidance and Counselling Coordinators (GCC) at schools in 6 sessions. The six sessions will include a) psychoeducation on depression, b) behavioural activation (helping the participant see the connection between their behaviour, daily activities, and low mood and activity scheduling) and c) problem-solving therapy (the GCC helps the participant identify and define a specific problem to work on, evaluate the potential solutions to the problem, and carry out the selected solution(s)).

Y-MIND Intervention

Enhanced Usual Care (EUC): Guidance and counselling coordinators in the schools provide some counselling to students who need it. Building on the existing structure, enhanced usual care in the Y-mind programme, will be enhanced in three ways: 1) Teaching staff will receive basic training on common mental health conditions affecting youth in Ghana with an emphasis on depression and suicidal symptoms and treatment. The WHO guidelines for school health services will form the basis for the training for teachers. 2) Nurses in all schools and other relevant local health care professionals will be trained in mental health, substance-use and self-harm including guidelines on when and where to refer young people for psychiatric care. The World Health Organization (WHO) Mental Health Gap intervention guide (mhGAP) will be used for training of nurses and other health care professionals . 3) The study team will provide a letter for the Guidance and Counselling Coordinators for the participant.

Enhanced Usual Care

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navrongo Health Research Centre

Navrongo, Ghana

Location

Related Publications (2)

  • Attah DA, Bere CT, Smith P, Adde KS, Bawa S, Achana F, Owusu L, Dambayi E, Ayuure C, Jopling R, Glozah F, Aborigo R, Chibanda D, Abas M, Weobong B. The African youth in mind (Y-MIND) brief psychological intervention for depression among school-going adolescents in Ghana: a development case series. BMC Psychiatry. 2026 Mar 5. doi: 10.1186/s12888-026-07938-w. Online ahead of print.

  • Jopling R, Attah D, Abas M, Adde KS, Goldsmith K, Bere T, Nyamayaro P, Aborigo RA, Barrett B, Owusu L, Glozah F, Akanlu A, Bawa S, Achana FS, Danese A, Smith P, Seward N, Kumwenda M, Chibanda D, Weobong B. African Youth in Mind - Protocol of a Pilot feasibility trial of a brief psychological Intervention for older adolescents with depression delivered through senior high schools in Navrongo, Ghana. PLoS One. 2025 Apr 1;20(4):e0319462. doi: 10.1371/journal.pone.0319462. eCollection 2025.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 18, 2024

Study Start

July 1, 2024

Primary Completion

February 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations