Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202101590919131 Date of Approval: 27/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of brief psycho-education intervention on caregiver burden of caregivers of children and adolescents with Mental Retardation attending the outpatient clinic in the Federal Neuropsychiatric hospital Benin city, Nigeria.
Official scientific title Impact of brief psycho-education intervention on caregiver burden of caregivers of children and adolescents with Mental Retardation attending the outpatient clinic in the Federal Neuropsychiatric hospital Benin city, Nigeria.
Brief summary describing the background and objectives of the trial Mental Retardation is a chronic disorder that requires constant and daily care with attention from the care givers. Parents and other family members are often the care providers who not only give care but have to deal with the problems associated with the child’s disabilities thus the caregivers are prone to burden. Though a number of studies have examined burden experienced by caregivers, in Nigeria, limited research has been undertaken that examined the impact of Brief psychoeducation intervention on burden. Aims & Objectives The study set out to determine the prevalence and the socio-demographic correlates of burden as well as the impact of brief psycho-education intervention on caregiver burden among family caregivers of children and adolescents with Mental Retardation, receiving Out-Patient care at the Federal Neuropsychiatric Hospital (FNPH) Benin City.
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,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 02/09/2019
Actual trial start date 08/10/2019
Anticipated date of last follow up 24/03/2020
Actual Last follow-up date 20/04/2020
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 58
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Brief Psychoeducation weekly Four weeks Received both routine care (comprised pharmacological and psychosocial management of clinic attendees and supportive counseling for clinic attendees and caregivers) and a brief psycho-education intervention consist of a 45 -minute group session every week for a month. The intervention had four parts: Week 1. Introduction and education on Mental Retardation. Week 2. Skills to improve coexistence in the family. Week 3. Relative’s self-care. Week 4. Feedback and evaluation. Apart from the first session subsequent sessions began with a recap of the previous session and ended with a summary of the session for that day. 29
Control Group Routine Care monthly Four weeks Routine care comprised pharmacological and psychosocial management of clinic attendees and supportive counseling for clinic attendees and caregivers. 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. The family caregiver who is at least 18 years old and offers at least 6 hours of care daily. 2. Caregivers who give their consent to participate in the study. 1. A caregiver who is paid to care for the patient. 2. A caregiver who is too ill to participate in the study (chronic/acute physical or psychological illness). Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 11/10/2017 Federal Neuropsychiatric Hospital Ethics committee
Ethics Committee Address
Street address City Postal code Country
New lagos road Benin City 300271 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. The outcome measure was impact of BPEI on caregiver burden and dimensions of caregiver burden of caregivers of children and adolescent diagnosed with Mental retardation. 4th week and 8th week
Secondary Outcome The prevalence of caregiver burden and correlates of baseline caregiver sociodemographic. Baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Neuropsychiatric Hospital New lagos road Benin City 300271 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Atim Archibong New Lagos Road Benin City 300271 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Atim Archibong New Lagos Road Benin City 300271 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Imafidon Agbonile New Lagos Road Benin City 300271 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atim Archibong eka_56@yahoo.com +2347034594499 New Lagos Road
City Postal code Country Position/Affiliation
Benin City 300271 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Imafidon Agbonile unival2002@yahoo.com +2348060364812 New Lagos Road
City Postal code Country Position/Affiliation
Benin City 300271 Nigeria consultant
Role Name Email Phone Street address
Scientific Enquiries Atim Archibong timma84@gmail.com +2347034594499 New Lagos Road
City Postal code Country Position/Affiliation
Benin City 300271 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol When will data be available (start and end date)? Beginning 3 months and ending 5 years following article publication With who? Researchers who provide a methodologically sound proposal. For what types of analyses? To achieve aims in the approved proposal. The proposal should be directed to timma84@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 3 years at a third party website (Link to be included)
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