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: www.pactr.org
Trial no.: PACTR201901730324304 Date of Approval: 14/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PSYCHOSOCIAL STIMULATION INTERVENTION FOR SEVERELY MALNOURISHED CHILDREN
Official scientific title THE EFFECTS OF PSYCHOSOCIAL STIMULATION ON DEVELOPMENT, GROWTH, AND TREATMENT OUTCOME OF SEVERELY MALNOURISHED CHILDREN IN SOUTHERN ETHIOPIA: A CLUSTER RANDOMIZED CONTROL TRIAL (EPSoSAMC Study)
Brief summary describing the background and objectives of the trial There is robust evidence to indicate that Severe Acute Malnutrition (SAM) in early childhood delays the mental and behavioral development of children. Psychosocial stimulation through play programs that start during rehabilitation and continue after discharge can substantially reduce the risk of permanent intellectual disability and emotional impairment among severely malnourished children. However, the stimulation intervention received little programmatic and research attention in Ethiopia. Globally, few studies were conducted to examine the effect of psychosocial stimulation interventions provided in conjunction with the routine nutritional care of children with SAM. However, the studies have certain methodological issues that lead to very low-quality findings across important outcome indicators. Few of the limitations include the introduction of information contamination, the high level of lost to follow up and unequal observation between the intervention groups. Furthermore, in most of the studies, the full World Health Organization (WHO)  recommendations on Emotional and Physical stimulation were not implemented. The studies conducted previously did not also adequately address the impact of the intervention on important treatment outcome indicators. In spite of the fact that, positive findings have been observed from the previous few studies and the promotion of psychosocial stimulation intervention by well recognized international organizations such as the WHO, the finding of a recent systematic review clearly indicated the need for further scientific evidence behind the provision of psychosocial stimulation for children with SAM. The overall objective of the project is to examine the effect of psychosocial stimulation provided in integration with the routine inpatient care and for six months thereafter on the development, growth and treatment outcomes of children with SAM age 6 – 59 months in Southern Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EPSoSAMC Study
Disease(s) or condition(s) being studied Psychosocial stimulation of children with Severe Acute Malnutrition
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/03/2019
Actual trial start date
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 144
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Psychosocial Stimulation for Children and Health Education for Mothers In the nutrition unit of the intervention health facilities, the child will participate in an informal stimulation session and in a half-hour of individual play session on a daily basis. In the six months follow up period after the discharge from the inpatient care, the play guides/ intervention worker will visit the household five times at the end of 1st week, 2nd weeks, 1st month, 3rd months, and 6th months and facilitate a half-hour individual stimulation session. In the Nutritional unit, the mothers/ caregivers will receive weekly Health Education sessions on the stimulation related topics. They will also receive two additional health education sessions weekly on general health-related topics. The Health Education will be given to the mothers/ caregivers at each of the scheduled home visits as well. During the in-patient care of children in the nutrition unit and for six months after discharge from the nutrition unit. In this study, the full WHO recommendations on Psychosocial stimulation will be implemented. After the initial phase of the treatment (Phase-I), children with SAM in the intervention health facilities will participate in the psychosocial stimulation intervention through play program. In the nutrition unit, the child will spend prolonged periods on large play mats with other children, mothers and/or a play guide/ intervention worker. Each of the mother/ caregiver and their child will also participate in an individual play session with a play guide/ intervention worker. The play activities and toys are selected to develop both motor and language skills based on the WHO recommendation. Each play session will include language activities, motor activities, and activities with toys. Inexpensive locally made and Western toys will be used. For children who are unable to move, passive limb movements and splashing in a warm bath will be used to promote mobility. The play activities will include rolling on a mattress, running after and tossing a ball, climbing stairs and walking. The mothers/ caregivers will be encouraged to play and chat with their children and given new skills and positive feedback to continue the activities between the scheduled sessions. In the six months follow up period after the discharge from the inpatient care, the play guides/ intervention worker will facilitate a half-hour individual stimulation session in each of the scheduled home visits where they will play with the child, the mother/caregiver, and other family members if any. The mothers/ caregivers will receive health education on the stimulation related topics such as the benefits of the stimulation intervention, how to facilitate the intervention and the preparation of locally made play materials. Similar with the mothers/ caregivers in the control group, they will also receive health education on general health-related topics such as child nutrition, child feeding, sanitation, and hygiene. 72
Control Group Standard Care without Psychosocial Stimulation for Children and Health Education for Mothers In the control Health Facilities, children with SAMage 6 – 59 months will receive the routine in-patients care in the nutrition unit without psychosocial stimulation. In the six months follow up period after the discharge from the inpatient care, the intervention worker will visit the household five times at the end of 1st week, 2nd weeks, 1st month, 3rd months, and 6th months for the home-based follow up. In the Nutritional unit, the mothers/ caregivers will receive two health education sessions weekly on the general health-related topics. The Health Education will be given to the mothers/ caregivers at each of the scheduled home visits as well. During the in-patient care of children in the nutrition unit and for six months after discharge from the nutrition unit. In the control Health Facilities, children with SAM age 6 – 59 months will receive the routine in-patients care without psychosocial stimulation and home-based follow up for six months after discharge from the nutrition unit. The mothers/ caregivers receive health education on general health-related topics such as child nutrition, child feeding, sanitation, and hygiene. 72 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Children age 6 – 59 months with the diagnosis of SAM fulfilling the inpatient admission criteria based on the national protocol for the management of SAM. - The mother/ caregiver of the child has a plan to stay in the study area for at least six months after the discharge of her children from the Nutrition Unit - The mother/ caregiver of the child agrees for the inpatient care of SAM during Phase 2 treatment in the SC - The mother/ caregiver of the child agrees to present at the Nutrition Unit during the inpatient care - Children with the diagnosis of other chronic medical conditions including TB, and HIV/AIDS that could be identified by the health workers during admission or later - Children with clinically apparent congenital abnormalities, obvious disabilities, mobility problems and sensory impairments (hearing and visual problems) that could affect outcome measurements and those children with twin birth - Families of children living far from the health included in the study Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(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 09/10/2018 Institutional Review Board of St. Paul Hospital Millennium Medical College
Ethics Committee Address
Street address City Postal code Country
Swaziland Addis Ababa 1271 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child Development is the Primary Outcome. The five areas of child development including personal-social, fine motor, language, gross motor, and social-emotional skills will be measured. The first four of the developmental dimensions will be measured using the Denver II-Jimma which is culturally adapted, standardized and translated tool previously used in the Ethiopian context to assess the developmental performance of children age less than six years. The remaining social-emotional dimensions of the child development will be measured using the parent-completed Ages and Stages Questionnaire: Social-Emotional (ASQ:SE). The tool was adapted and translated for the Ethiopian context and previously used in the number of studies. It will be Measured before the intervention when the child is transferred from Phase I to the transition, upon discharge from the Nutrition Unit and at 3 and 6 months after discharge
Secondary Outcome Child Growth is the secondary outcome. The Weight, Length/height and Mid Upper Arm Circumference (MUAC) of the children will be measured following the standard procedure expressed in the Ethiopian Guidelines for the Management of Acute Malnutrition. The anthropometric Z-scores and percentile of the median will be compared with the WHO reference population. It will be assessed before the intervention when the child will be transferred from Phase I to the transition, upon discharge from the Nutrition Unit and at 3 and 6 months after discharge
Secondary Outcome Treatment outcome is the secondary outcome. Death rate, recovery/cure rate, defaulter rate, non-responder rate, the average rate of weight gain, and the average length of stay of children in the nutrition unit will be calculated based on the Ethiopian Guidelines for the Management of Acute Malnutrition (Ethiopian FMoH, 2016). The proportion of cases that will have relapsed SAM within the six months follow up period will be calculated. Children will be considered to a have relapse, when their WFL/H will be less than 70 % of the WHO reference median or less than – 3 Z score OR having a pitting Edema of both feet OR MUAC <11.5 cm for child length greater than 65 cm. It will be assessed by recording each of the treatment outcome related events in the facility and home-based follow up period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Werabe Hospital Worabe Werabe Ethiopia
Garbibar Health Center Kibet Kibet Ethiopia
Kuno Health Center Kibet Kibet Ethiopia
Elos Health Center Kibet Kibet Ethiopia
Meneharia Health Center Kibet Kibet Ethiopia
Kibet Hospital Kibet Kibet Ethiopia
Archuma Wonte Lanforo Lanforo Ethiopia
Gebaba Health Center Lanforo Lanforo Ethiopia
Rape Health Center Lanforo Lanforo Ethiopia
Mito Health Center Lanforo Lanforo Ethiopia
Tora Hospital Lanforo Lanforo Ethiopia
Nadugna Agam Health Center Dalocha Dalocha Ethiopia
Ebot trora Health Center Dalocha Dalocha Ethiopia
Dalocha Health Center Dalocha Dalocha Ethiopia
Kerate Health Center Hulbareg Hulbareg Ethiopia
Ambenicho Gimba Health Center Hulbareg Hulbareg Ethiopia
Bilawanja Health Center Hulbareg Hulbareg Ethiopia
Alem Gebeya Hospital Sankura Sankura Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
St Paul Hospital Millennium Medical College Swaziland Addis Ababa 1271 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Kochi Jimma 0378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Professor Tefera Belachew Kochi Jimma 0378 Ethiopia
Dr Teklu Gemechu Kochi Jimma 0378 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tesfalem Teshome Tessema tesfabemnet2005@gmail.com +251911379563 Kolfe Keranio
City Postal code Country Position/Affiliation
Addis Ababa 1271 Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries Tesfalem Teshome Tessema tesfabemnet2005@gmail.com +251911379563 Kolfe Keranio
City Postal code Country Position/Affiliation
Addis Ababa 1271 Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries Andamlak Gizaw Alamdo gizandal@gmail.com +251912038993 Kolfe Keranio
City Postal code Country Position/Affiliation
Addis Ababa 1271 Ethiopia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Not Available 10/01/2019 10/01/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Not Available
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 03/01/2019 This information was missed in the previous application Professor Tefera Belachew, Kochi, Jimma, 0378, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 03/01/2019 This information was missed in the previous application Dr Teklu Gemechu, Kochi, Jimma, 0378, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 03/01/2019 This information was missed in the previous application Health facilities in Siliti Zone, Siliti Zone, Werabe and the Surrounding areas, , Ethiopia Werabe Hospital, Worabe, Werabe , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 04/01/2019 Actual Trial Start Date is not yet known 01 May 2019
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 04/01/2019 Mistake in writing 31 Dec 2019 31 Jan 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 04/01/2019 Completion Date is not yet known 31 Mar 2020
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Garbibar Health Center, Silti , Silti , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Kuno Health Center, Silti , Silti , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Elos Health Center, Silti , Silti , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Meneharia Health Center, Kibet, Kibet, , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Kibet Health Center, Kibet, Kibet, , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Garbibar Health Center, Silti , Silti , , Ethiopia Garbibar Health Center, Kibet, Kibet, , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Kuno Health Center, Silti , Silti , , Ethiopia Kuno Health Center, Kibet, Kibet, , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Elos Health Center, Silti , Silti , , Ethiopia Elos Health Center, Kibet, Kibet, , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Kibet Health Center, Kibet, Kibet, , Ethiopia Kibet Hospital, Kibet, Kibet, , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Archuma Wonte, Lanforo , Lanforo , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Gebaba Health Center, Lanforo , Lanforo , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Rape Health Center, Lanforo , Lanforo , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Mito Health Center, Lanforo , Lanforo , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Tora Hospital, Lanforo , Lanforo , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Nadugna Agam Health Center, Dalocha , Dalocha , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Ebot trora Health Center, Dalocha , Dalocha , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Dalocha Health Center, Dalocha , Dalocha , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Kerate Health Center, Hulbareg , Hulbareg , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Ambenicho Gimba Health Center, Hulbareg , Hulbareg , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Bilawanja Health Center, Hulbareg , Hulbareg , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 04/01/2019 The data were incomplete Alem Gebeya Hospital, Sankura , Sankura , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 04/01/2019 Just to make more easy title for the public THE EFFECTS OF PSYCHOSOCIAL STIMULATION ON DEVELOPMENT, GROWTH, AND TREATMENT OUTCOME OF SEVERELY MALNOURISHED CHILDREN IN SOUTHERN ETHIOPIA PSYCHOSOCIAL STIMULATION INTERVENTION FOR SEVERELY MALNOURISHED CHILDREN
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results summary 10/01/2019 The data were incomplete Not Available
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of results summaries 10/01/2019 The data were incomplete. The date for posting the result summaries is no yet decided. 10 Jan 2019
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 10/01/2019 The data were incomplete. The date of the first journal publication of results is not yet decided. 10 Jan 2019
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 10/01/2019 The data were incomplete Not Available
Section Name Field Name Date Reason Old Value Updated Value
Reporting Baseline characteristics 10/01/2019 The data were incomplete Not Available
Section Name Field Name Date Reason Old Value Updated Value
Reporting Participant flow 10/01/2019 The data were incomplete The Participant Flow is presented as an attachment.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Adverse events 10/01/2019 The data were incomplete Not Available
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measures description 10/01/2019 The data were incomplete The outcomes that will be measured are presented in the attachment
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 10/01/2019 The data were incomplete Not Available
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measure document 10/01/2019 The data were incomplete 5739_1238_4738.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Participant flow document 10/01/2019 The data were incomplete 5739_1238_4739.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 10/01/2019 The data were incomplete No Yes