Navrongo Health Research Centre
Navrongo, Ghana
NCT Number: NCT06740084
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.
This study is active but is not currently recruiting participants.
Notify Me15 year–18 year
All sexes
Interventional
Not applicable
Navrongo, Ghana
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 months post baseline assessment
Alcohol use measured as the difference in mean score on the Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Screening to 5 months post baseline assessment
Feasibility of conducting a fully powered trial measured as the proportion of those screened who are eligible, the proportion of those eligible who consent to take part, and the proportion of those who consent who complete the 5 month primary follow up assessment.
Time frame: Baseline to 5 month post baseline assessment
Two types of resource use and cost data will be collected for the economic evaluation; patient and programme level costing of both direct (healthcare cost) and indirect (productivity loss) cost. Both financial (actual money spent) and economic cost (e.g. donated items and volunteering time) will be assessed.
King's College London
Other
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