Developing culturally-relevant family interventions for people with psychosis in Indonesia

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: Over 12 months, the researchers will recruit a convenience sample of 60 service‐user and family member dyads to i) compare recruitment and retention in different settings and delivered by different health professionals, ii) assess the feasibility of collecting participant outcome measures at study entry, post‐intervention and 6 months later, iii) assess the usability and acceptance of the intervention manual by non‐specialist healthcare workers in primary care, iv) measure fidelity to the model and healthcare workers adherence to the intervention model and v) assess the acceptability of the intervention to recipients. Participants will be randomised to receive family interventions or to continue with treatment as usual at a ratio of 1:1. Randomisation will be carried out remotely using randomisation software according to the International Conference on Harmonization E9 Statistical Principles Guidelines and will be implemented by the trial manager. The intervention is based on a widely used cognitive‐behavioural model of family interventions developed by Barrowclough and Tarrier and adopted as the model of choice in NICE‐approved interventions. The family intervention will offer therapeutic elements to enhance family skills and knowledge, communication skills training, enhancing skills in problem‐solving and goal‐setting underpinned by cognitive models and framed by collaborative partnerships to enhance supportive therapeutic relationships. The intervention is typically delivered over 12 weeks and will consist of up to 10 sessions. The intervention adaptation will be co‐produced locally synthesising stakeholders’ preferences and priorities for intervention delivery and using consensus methods to determine the mode and de CONDITION: Schizophrenia ; Mental and Behavioural Disorders ; Schizophrenia PRIMARY OUTCOME: ; 1. Acceptability and satisfaction with the intervention will be measured quantitatively by attendance and retention in the intervention and qualitatively using in‐depth interviews with carers and family members of those with schizophrenia post‐intervention; 2. Recruitment and retention will be measured using numbers of participants identified by healthcare workers, numbers approached to participate, numbers consenting to take part, numbers randomised and numbers of participants who complete the intervention and are retained in both arms post‐intervention and 3 months; 3. Recruitment and retention will also be measured using numbers of complete outcome measures described in the secondary outcome measures below post‐intervention; 4. Fidelity to the intervention and experience of delivering the intervention will be measured using items drawn from the adapted manualised intervention and measured using therapist report and therapy diaries post‐intervention; INCLUSION CRITERIA: Carers/relatives will be included if they are: 1. Living with or spending at least 10 hours per week in face‐to‐face contact with an individual with schizophrenia and assuming a caring role 2. Over the age of 18 years 3. Resident of Bogor or Jakarta 4. Able to give informed written consent SECONDARY OUTCOME: ; 1. Symptom severity and relapse rates will be measured by administering the Positive and Negative Syndrome Scale (PANSS) to participants with schizophrenia at baseline, post‐intervention and at 3 months follow‐up; 2. Social functioning will be measured by administering the Personal and Social Performance Scale (SPS) to participants with schizophrenia at baseline, post‐intervention and at 3 months follow‐up; 3. Family environment and functioning will be measured using the Family Questionnaire administered at baseline, post‐intervention and at 3 months follow‐up; 4. Therapeutic engagement will be measured quantitatively using attendance levels, number of sessions attended and completion of the intervention post‐intervention;
Epistemonikos ID: f5ec7bb3facd53b69af069fee7cd9054c0c68b76
First added on: Aug 25, 2024