Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/03/2015
Date assigned
17/04/2015
Last edited
16/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
East Africa is suffering from devastating droughts and, in Ethiopia, it is estimated that there are 652,000 malnourished children under the age of five in need of emergency food. Malnutrition prevents a child from developing normally and can often lead to death. It also has a negative effect on the relationship between a parent and child. We know that parental support of a child, such as playing with toys with them, has a positive effect on a childs’ development. However, in many developing countries only 10-40% of parents give stimulating materials such as toys to their child. Also, for varying reasons many parents don’t play with their children. We aim to improve this situation by using a simple intervention called Emotional Stimulation (ES). ES was developed by Play Therapy Africa to help mothers reconnect more fully with their malnourished child. Parents learn simple activities such as games that they can play with their children. In this study, youths and Health Extension Workers (HEW) who staff Health Posts attended by parents of malnourished children will be trained to teach parents ES and Nutritional Education (NE). NE teaches parents important information about their children, such as dietary needs and hygiene. Either ES or NE will be taught to parents alongside the provision of emergency food. The aim of this study is to see whether ES is better than NE at helping children to recover from malnutrition in Ethiopia.

Who can participate?
Children with severe acute malnutrition.

What does the study involve?
Health Posts (intervention sites) are randomly put into one of two groups and patients will receive either ES or NE depending on which Health Post they attend. Health Posts are staffed by a HEW and youths trained to give ES or NE to parents and/or caregivers. Each family participating in the study receives 12 weeks treatment with either ES or NE.

What are the possible benefits and risks of participating?
This study may benefit participants by improving nutrition and family bonding. The results will also be used to see whether ES could be used in the wider populations in East Africa that are severely affected by drought.

Where is the study run from?
Play Therapy Africa (Ethiopia)

When is the study starting and how long is it expected to run for?
February 2012 to August 2012

Who is funding the study?
Pulitzer Foundation (UK)

Who is the main contact?
Prof P Fonagy
p.fonagy@ucl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Professor Peter Fonagy

ORCID ID

Contact details

1-19 Torrington Place
London
WC1E 7HB
United Kingdom
+44 (0) 20 7679 1943
p.fonagy@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Emotional stimulation as a cost-effective addition to emergency food intervention for malnutrition in a low income country: a randomised controlled trial

Acronym

Study hypothesis

An Emotional Stimulation (ES) designed to improve mother-child interaction will lead to a greater increase in weight gain in severely malnourished children than Nutritional Education (NE) alone.

Ethics approval

1. University College London Research Ethics Committee, 15/09/2011, ref: 3325/001
2. Federal Democratic Republic of Ethiopia Ministry of Science and Technology Ethics Review Committee, 15/11/2011, ref: 310/510/04

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Severe acute malnutrition

Intervention

1. Emotional Stimulation (ES): a brief, structured, intense psychosocial bonding exercise taught to participating mothers
2. Nutritional Education (NE): participating mothers are given information about the link between good nutrition and health based on the Ethiopian Government’s information pack drawn up to support mothers with malnourished infants and young children

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Body Mass Index (BMI) of infants measured by health extension workers who will record height and weight measurements at weekly intervals for 12 weeks

Secondary outcome measures

Secondary measures will be collected by data collectors at baseline and at 4, 6, 8 and 12 weeks until discharge:
1. Ages and Stages Questionnaire
2. General Health Questionnaire
3. Pearlin and Schoolers’ seven-item scale
4. Global Rating Scale
5. Coding Interactive Behaviour Scale
6. Quality of interaction between parent and child (Ainsworth Sensitivity Coding Scale)
7. Parents’ perception of the child (qualitative interview)
8. The Bayley Scales will be administered to a sub-sample of randomly identified cases by a supervisor trained in the assessment of infants

Overall trial start date

01/02/2012

Overall trial end date

31/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 6 months and 5 years
2. Severe acute malnutrition defined as 3 SD below WHO published norms of height or forearm skin-fold thickness less than 110mm
3. Pass appetite test
4. Sufficient family involvement to ensure intervention

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

432

Participant exclusion criteria

1. Serious medical complications requiring referral for inpatient treatment
2. Clinically apparent congenital abnormality
3. Preterm birth (<37 weeks gestation) or birth weight > 2SD below weight/gestation limit

Recruitment start date

01/02/2012

Recruitment end date

31/03/2012

Locations

Countries of recruitment

Ethiopia

Trial participating centre

Play Therapy Africa
Ethiopia

Sponsor information

Organisation

University College London

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom
+44 (0) 20 7679 2000
gradweb@ucl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Pulitzer Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish two papers. We hope that papers will appear about the major findings and the follow up in 2016-7. The intended journals are primarily general medical journals given the relevance of the research to the care of malnourished infants.

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes