Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310908063134 Date of Registration: 16/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SPARK: a clustered randomised trial of the WHO Caregiver Skills Training to SuPport African communities to increase the Resilience and mental health of Kids with developmental disabilities and their caregivers in Kenya and Ethiopia
Official scientific title SPARK: a clustered randomised trial of the WHO Caregiver Skills Training to SuPport African communities to increase the Resilience and mental health of Kids with developmental disabilities and their caregivers in Kenya and Ethiopia
Brief summary describing the background and objectives of the trial African families with children with developmental disabilities (DD) experience severe challenges, including social isolation, stigma, and poverty. Most children with DD receive no formal support. To address this gap the World Health Organization (WHO) developed the Caregiver Skills Training (CST) programme for families of children with DD (WHO, 2022). The programme is designed to be delivered by non-specialist facilitators and suitable for low-income contexts. Previous pilot studies in Ethiopia and Kenya indicated the CST is acceptable and feasible to implement. The effectiveness of the programme delivered by non-specialist facilitators remains to be established. This large 2-arm assessor masked hybrid type 1 implementation effectiveness clustered superiority randomised controlled trial (RCT) conducted across 4 rural and urban sites in Ethiopia and Kenya aims to assess the effectiveness of the WHO CST programme compared to enhanced care as usual at reducing emotional and behavioural problems in children with DD and improving their caregivers’ quality of life at 4 months after randomisation. The secondary objectives are to investigate the effectiveness of the intervention in sustaining any intervention effects on the primary outcomes at follow-up (10 months after randomisation), and examine effects at 4 months post randomisation on a) caregivers’ experienced stigma, b) affiliate stigma; c) caregivers’ depressive symptoms; d) household food insecurity; e) child physical punishment; f) caregivers’ self-reported skills relating to the CST; g) caregiver health-related quality of life; h) child health-related quality of life; i) caregiver social support; and j) child mode and functions of communication. We will also evaluate the programme’s cost-effectiveness and identify contextual determinants that influence the effectiveness of implementation efforts and future scale-up of the programme. Due to security challenges the rural Ethiopian site may not be able to open.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SPARK
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 30/10/2023
Actual trial start date 09/04/2024
Anticipated date of last follow up 31/07/2025
Actual Last follow-up date 28/02/2026
Anticipated target sample size (number of participants) 544
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL https://www.thesparkproject.net/
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group The World Health Organzations Caregiver Skills Training Programme The intervention comprises nine weekly group sessions and three home visits. Each weekly group session lasts approximately three hours, whereas home visits last approximately 90 minutes each. 12-15 weeks The WHO CST programme is a parent-mediated intervention developed for caregivers of children with developmental disabilities aged between 2-9 years old. The programme is based on social learning, applied behaviour analysis, positive parenting and developmental theories. It teaches caregivers strategies to promote communication, play, learning, and adaptive behaviours in their children. Topics covered in the weekly group sessions include, 1) Introduction and psychoeducation; 2) engaging with the child; 3) helping children share engagement; 4) understanding communication; 5) promoting communication; 6) learning new skills; 7) preventing challenging behaviour; 8) responding to challenging behaviour; and 9) problem-solving and self-care. The first home visit, which takes place before the weekly group sessions start, focuses on defining family-specific goals. Subsequent home visits occur at the intervention's mid-point and end and focus on evaluating progress, troubleshooting, and identifying and supporting additional family needs. The intervention is delivered by trained non-specialist facilitators, under the supervision of trained specialist facilitators and master trainers, using methods like role-plays, case-study vignettes and group discussions. CST materials, including manualised facilitator and participant booklets, inform the delivery of group sessions and home visits. 272
Control Group Waitlist enhanced care as usual In all SPARK clusters, healthcare workers in the local health centres (Ethiopia and Kenya) and health or education workers (in Kenya) will receive training based on principles outlined in the developmental disorders module of the World Health Organization’s mhGAP intervention guide (WHO, 2016). Very few health workers in Kenya and Ethiopia are trained in the identification and care for children with developmental disabilities. Therefore, ensuring access to health or education workers who have received this training constitutes enhanced usual care. The comparison arm will receive the WHO CST programme after the follow-up data collection is completed. Access to mhGAP trained health and/or education workers: throughout the trial. Receipt of WHO CST programme after follow-up data collection is completed: 12-15 weeks In all SPARK clusters, healthcare workers in the local health centres (Ethiopia and Kenya) and health or education workers (in Kenya) will receive training based on principles outlined in the developmental disorders module of the World Health Organization’s mhGAP intervention guide (WHO, 2016). Very few health workers in Kenya and Ethiopia are trained in the identification and care for children with developmental disabilities. Therefore, ensuring access to health or education workers who have received this training constitutes enhanced usual care. The comparison arm will receive the WHO CST programme after the follow-up data collection is completed. 272 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Child: - Age between 2 and 9 years. This is the target age the WHO CST programme was developed for. The CST is unsuitable for children under 2 years as it presumes a higher level of developmental maturation, and is unsuitable after age 9 years because puberty and sexual maturation then become important issues. - DSM-5 diagnosis of specific neurodevelopmental disorders associated with impairments in social and social communication domains, including 1. Autism Spectrum Disorder 2. Intellectual Disabilities (intellectual disability; global developmental delay; unspecified intellectual disability). In addition, also we will include children with conditions with a known cause with intellectual disability as a consequence, e.g. Down’s syndrome, Prader Willi Syndrome and Foetal Alcohol Syndrome. 3. Communication disorders: Language disorder and Social Communication Disorder only (not including speech sound disorder, childhood onset fluency disorder or unspecified communication disorder) Caregiver: - Having the long-term caring responsibility for a child aged 2-9 years with a DD, preferably as the primary caregiver - Resident in the same household as the child and having sufficient contact time during the week with the child with DD (seeing the child at least 5 days a week on average) to carry out homework exercises - Able to attend three individual home-based sessions and nine group sessions - Intending to stay within the study area for the next 12 months - Ability to speak Amharic/ Kiswahili/Kigiriama/English (as appropriate for the site) - Caregiver is 18 years of age or older, or caregiver is younger than 18 years and the biological parent of the child with DD (and therefore considered emancipated youth) Child: - Other neurodevelopmental disorders in the DSM-5 (ADHD, motor disorders, specific learning disorder) without the presence of autism, communication disorder, intellectual disability or global developmental delay will be excluded. The CST focuses on addressing delays and impairments in the social and communication domain; children with diagnoses in these other categories of neurodevelopmental disorders have needs that are not well aligned with the strategies offered in the programme. - Children with epilepsy only without co-occurring neurodevelopmental disorder. - Child with DD is in need of urgent medical attention (for condition other than DD); - Severe malnutrition: assessed using Mid Upper Arm Circumference, with <115mm as cut-off following World Health Organization (WHO) guidance (children up to 5 years) or using body mass index (for children >5 years) with a clinical specialist confirming malnutrition is so severe the child is unlikely to directly benefit from CST; - Child has co-occurring physical or sensory disabilities or health problems that mean the strategies taught in the CST are unsuitable, including: o Severe to profound hearing loss, severe visual impairment or totally blind (mild/moderate impairments are permitted); o Severe motor impairment: inability to sit independently; inability to move upper extremities independently. Caregiver: - Lives outside the delineated study cluster - Family took part in the CST programme previously - Caregiver is in need of urgent medical attention. - Caregiver has sensory disabilities or intellectual disabilities that severely limit the caregiver’s ability to participate in the CST and/or to implement CST strategies with their child, including: o Severe to profound hearing loss, severe visual impairment or totally blind; o Having a difficulty to communicate because of impaired speech; o Moderate, severe or profound intellectual disability Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Year(s) 9 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/03/2024 Kings College London Research Ethics Subcommittee
Ethics Committee Address
Street address City Postal code Country
Franklin Wilkins Building London SE1 9NH United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/03/2024 Addis Ababa University College of Human Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Zambia Street, Addis Ababa University CHS Building number 710 Addis Ababa N/A Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/02/2024 Aga khan University Institutional Scientific and Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, off Limuru Road Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/02/2024 KEMRI WTRP Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
House No 8 KEMRI Headquarters Kilifi N/A Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome variables are the PedsQL measuring caregiver’s quality of life and the CBCL assessing the child’s behavioural problems. The CBCL (Achenbach & Rescorla, 2000 2001) is a 99 (pre-school age) or 113 (school age) item caregiver-report questionnaire assessing the frequency of the child’s externalising and internalising problem behaviours, including anxiety and depression. It has been translated and validated in a large number of languages around the world, including Amharic and Swahili (Kariuki et al., 2016; Magai et al., 2018). Analyses will be done using the raw CBCL Total scores. The PedsQL Family Impact module (Varni et al., 2004) is a 36-item scale that assesses the impact of the child’s condition on family functioning, including the caregiver’s physical, emotional, social and cognitive functioning, communication and worry, as well as on the family’s daily activities and family relationships. The scale has previously been translated and validated in many languages, and we translated and validated the measure to Amharic (Borissov et al., 2021) and Swahili. The PedsQL urgent version will be used, asking about the family’s quality of life across the past 7 days. Analyses will be conducted on PedsQL Total scores, including all 36 items. T0: Baseline, T1: 18 weeks plus minus 2 weeks post randomisation, and T2: 44 weeks plus minus 2 weeks post randomisation
Secondary Outcome The main secondary outcomes will be the intervention effect on PedsQL and CBCL at T2. Ten additional secondary outcomes are specified, all focusing on T1. These include: 1. The Adapted Family Interview Schedule FIS stigma scale 2. The Patient Health Questionnaire PHQ-9 3. Household Food Insecurity Acess Scale-HFIAS 4. The discipline section UNICEF’s Multiple Indicator Cluster Survey-MICS 5. WHO caregiver knowledge skill test 6. EQ5D-5L 7. EQ5D-Y 8. Oslo Social Support scale 9. The Adapted Affiliate Stigma scale 10. The Communication Profile Adapted T0: Baseline, T1: 18 weeks plus minus 2 weeks post randomisation, and T2: 44 weeks plus minus 2 weeks post randomisation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Addis Ababa University College of Health Sciences Health Sciences Building, Tikur Anbessa Hospital Addis Ababa Ethiopia
Aga Khan University Institute for Human Development 06 Peponi Road Westlands Nairobi N/A Kenya
Kenya Medical Research Institute Welcome Trust Research Programme Hospital Road P.O. Box 230 Kilifi N/A Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health and care Research Grange House 15 Church Street Twickenham TW1 3NL United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kings College London 4.19 Waterloo Bridge Wing Franklin-Wilkins Building 150 Stamford Street London SE1 9NH United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Addis Ababa University NBH1, 4killo King George VI St, Addis Ababa Ethiopia
Aga Khan University 06 Peponi Road Westlands Nairobi Kenya
University of Oxford University Offices, Wellington Square Oxford OX1 2JD United Kingdom
Kenya Medical Research Institute Wellcome Trust Research Programme Hospital Road P.O. Box 230 Kilifi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rosa Hoekstra Rosa.Hoekstra@kcl.ac.uk +447506445561 Second Floor Addison House, room AH2. 06, Guys Campus Kings College London
City Postal code Country Position/Affiliation
London SE1 1 UL United Kingdom Kings College London
Role Name Email Phone Street address
Principal Investigator Amina Abubakar amina.abubakar@aku.edu +254705073853 06 Peponi Road Westlands, Nairobi
City Postal code Country Position/Affiliation
Nairobi N/A Kenya Aga Khan University
Role Name Email Phone Street address
Public Enquiries Melissa Washington Nortey spark@kcl.ac.uk +447944300429 Second floor Addison House, room AH2.06, Guys campus
City Postal code Country Position/Affiliation
London SE1 1UL United Kingdom Project manager
Role Name Email Phone Street address
Scientific Enquiries Rosa Hoekstra rosa.hoekstra@kcl.ac.uk +442078488079 Addison House, Room AH 2.05, Guys Campus
City Postal code Country Position/Affiliation
London SE1 1 UL United Kingdom Kings College London
Role Name Email Phone Street address
Scientific Enquiries Charlotte Hanlon charlotte.hanlon@kcl.ac.uk +251966253760 College of Health Sciences
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Addis Ababa University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the main trial article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol The full study protocol and informed consent forms will be posted on the Open Science Framework website (https://osf.io/) with a direct link to the SPARK website (https://www.thesparkproject.net/) once the protocol paper has been accepted for publication in a peer-reviewed journal. A pre-specified statistical analysis plan (SAP) will be drafted and approved by the study team and DSMB prior to conducting the analysis. The SAP will also be shared on the SPARK website (https://www.thesparkproject.net/). Access to the individual participant data underlying the results reported in the main trial paper will be made available beginning 12 months after the main trial article publication, with no end date. Access to the data is controlled by the SPARK executive group. Investigators wishing to use the data reported in the main trial will complete a publication proposal form, with an abstract of the proposed work, data sources, timelines, authorship and proposed dissemination. The proposal should be directed to Rosa.Hoekstra@kcl.ac.uk and Amina.Abubakar@aku.edu, who will circulate to the SPARK executive group for approval. Proposals will be evaluated on the following criteria: i) are the aims of the study proposed in line with the aims outlined in the original information sheet participants consented to?; ii) Is the study proposed sufficiently different from follow-on trial analyses SPARK affiliated researchers are working on? As stipulated in the SPARK publication plan (hosted on the SPARK website https://www.thesparkproject.net/) data sharing with teams involving students and researchers in Ethiopia and Kenya is prioritised, in line with the capacity building aims of the SPARK research programme. Upon approval, to gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.thesparkproject.net/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information