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.: PACTR201812802696820 Date of Approval: 20/12/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adapting and piloting WHO’s Parent Skills Training in a low income setting: a case study in Ethiopia
Official scientific title Adapting and piloting WHO’s Parent Skills Training in a low income setting: a case study in Ethiopia
Brief summary describing the background and objectives of the trial One of the major barriers to scaling up the service provision for children with developmental disorders (DD, including both autism and intellectual disability) and their families is the lack of skilled human resources (Patel et al., 2013). In Ethiopia this lack is particularly pronounced, with currently only two specialist child psychiatrists working in the country. Services for children with DD are restricted to the country’s capital and therefore inaccessible to the majority (85%) of the population living in rural areas (Tekola et al., 2016). The World Health Organization (WHO) and international partners recently collaborated in the development of a Caregiver Skills Training (CST) that can be delivered by non-specialist providers, is evidence-based and meets affordability and feasibility criteria of low-resource settings. The CST targets caregivers of 2-9 year old children with DD and aims to teach the caregivers strategies to engage their child in communication and play and promote adaptive behaviours and learning. The CST content is based on principles of social learning theory, positive parenting, applied behaviour analysis and developmental theories. The CST programme consists of a combination of nine weekly group sessions and three home visits. While the CST programme materials developed by WHO are based on the best available evidence, there is a need to explore whether it can be adapted to the Ethiopian context, can meet caregivers’ needs and can be effective in improving caregivers’ competencies and children’s behaviour and adaptive skills. In this project we aim to carry out a feasibility and acceptability study of the CST programme in rural Ethiopia using non-specialists as CST facilitators.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 30/11/2018
Actual trial start date 09/12/2018
Anticipated date of last follow up 31/03/2019
Actual Last follow-up date 31/05/2019
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 66
Recruitment status Completed
Publication URL
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Caregiver Skills Training Participants receive 9 weekly group sessions and a home visit prior to the first group session, halfway through the group sessions, and after the final group session. Participants receive 9 weekly group sessions and a home visit prior to mid and after the group sessions. Total programme comprises 12 weeks. 9 group sessions of approximately 3 hours duration each. In groups of max 10 caregivers the caregivers will be trained on strategies to engage their child in communication and play and promote adaptive behaviours and learning. The training content is based on principles of social learning theory, positive parenting, applied behaviour analysis and developmental theories. The nine group sessions each have a specific focus: 1) Introduction and psychoeducation; 2) engaging with the child; 3) helping children share engagement; 4) understanding communication; 5) promoting communication; 6) preventing challenging behaviour; 7) responding to challenging behaviour; 8) learning new skills; and 9) problem solving and self-care. These group sessions use a range of learning techniques including role-play, group discussions and case vignettes. The first home visit (prior to the CST start) is used to define specific goals and targets for each family; the two further home visits (midway and at the end of the training) focus on evaluating progress, trouble shooting and identifying possible additional support needs. 10
Control Group Caregiver Skills Training Waitlist control group The waitlist control arm receives the intervention after the follow-up assessment in the intervention arm is completed. During the trial the waitlist control group receives treatment as usual. After the follow-up assessment (two months post CST in the intervention arm) is completed, the waitlist control arm will receive the exact same intervention, comprising 3 home visits and 9 group sessions (see Experimental Group for details). The waitlist control arm receives the intervention after the follow-up assessment in the intervention arm is completed. During the trial the waitlist control group receives treatment as usual. After the follow-up assessment (two months post CST in the intervention arm) is completed, the waitlist control arm will receive the exact same intervention, lasting 12 weeks (see Experimental Group for details). During the trial the wait-list control arm receives treatment as usual and thus no intervention. After the follow-up assessment (two months post CST in the intervention arm) is completed, the waitlist control arm will receive the exact same intervention as the experimental group received during the trial (see Experimental Group for details). 10 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Having a long-term caring responsibility for a child aged 2-9 in whom a developmental disorder or delay has been identified by a health worker (no formal clinical diagnosis is required); Living within easy travelling distance of training site; Able to attend three individual sessions and nine group sessions; 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; Ability to speak Amharic; Willingness to give qualitative and quantitative feedback on the programme; Caregiver 18 years of age or older. Child with DD is acutely disturbed and/or in need of specialist medical attention; Lack of informed consent from caregiver; Child with DD has severe visual or hearing impairment 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 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 08/05/2018 PNM Research Ethics Subcommittee of Kings College London
Ethics Committee Address
Street address City Postal code Country
Franklin Wilkins Building, Waterloo Road, London, SE1 9NH London 0011 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 06/06/2018 Addis Ababa University College of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
IRB Office, 7th Floor, College of Health Sciences, Tikur Anbessa Hospital, PO 9086, Addis Ababa Addis Ababa 0011 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Caregiver child interaction CCI, rating based on video-taped interaction between caregiver and child rating adapted from Adamson et al., 2012. Rating conducted by trained raters blind to assessment time and intervention group status. pre- intervention, immediately post intervention after home visit 3, 2 month follow-up
Secondary Outcome -Caregiver knowledge and skills test. Measure developed by WHO CST team specifically assessing the caregiver’s knowledge and skills related to CST content. -The adapted Family Interview Schedule (FIS). The original FIS was developed to assess stigma experienced by relatives of people with psychosis (Sartorius & Janca, 1996) and has been adapted to be suitable for caregivers of children with DD in Ethiopia (Tilahun et al., 2016). The adapted FIS includes 14 questions about the family’s experience of stigma in the community and additional structured open-ended questions concerning the caregivers explanatory models about their child's condition. -The Autism Treatment and Evaluation Checklist (ATEC; (Rimland & Edelson, 1999). The ATEC is a one-page 77-item checklist completed by caregivers assessing developmental skills and severity of symptoms of developmental disorders. -Child Behavior Checklist ((CBCL/1½ -5, Achenbach & Rescorla, 2000); CBCL/6-18, (Achenbach & Rescorla, 2001). The CBCL is a caregiver-report questionnaire assessing the frequency of internalising and externalising problem behaviours. -Communication Profile-Adapted (CP-A; Bunning et al., 2014). A caregiver-reported questionnaire assessing the child's abilities and activities for communication, and participation in family and community events. -Patient Health Questionnaire-9 (PHQ-9; (Kroenke et al., 2001). A 9 item scale that assesses the severity of depressive symptoms in the caregiver over the past 7 days and is sensitive to change in symptoms. -PedsQL parent-reported Family Impact module (Varni et al., 2004). A 36 item scale that assesses the impact of the child's condition on family functioning pre intervention, immediately post intervention, 2 month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Addis Ababa University Black Lion Hospital, Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical research Council UK Medical Research Council, Polaris House, North Star Avenue Swindon 0021 United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kings College London Franklin Wilkins Building, Waterloo Road London 0011 United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Addis Ababa University 6th Floor, College of Health Sciences, Tikur Anbessa Hospital Addis Ababa 0011 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rosa Hoekstra Rosa.Hoekstra@kcl.ac.uk +442078488079 Department of Psychology, Second Floor Addison House, Guys Campus, Kings College London, SE1 1UL
City Postal code Country Position/Affiliation
London United Kingdom Senior Lecturer in Psychology
Role Name Email Phone Street address
Public Enquiries Charlotte Hanlon Charlotte.Hanlon@kcl.ac.uk +251912803374 6th Floor, College of Health Sciences, Tikur Anbessa Hospital
City Postal code Country Position/Affiliation
Addis Ababa 0011 Ethiopia Reader in Global Mental Health Kings College London
Role Name Email Phone Street address
Scientific Enquiries Rosa Hoekstra Rosa.Hoekstra@kcl.ac.uk +442078488079 Department of Psychology, Second Floor Addison House, Guys Campus, Kings College London, London, SE1 1UL
City Postal code Country Position/Affiliation
London United Kingdom Senior Lecturer in Psychology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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