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.: PACTR202212752100115 Date of Approval: 07/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Training Program for Parents of Preschool Children With Autism: A Randomized Controlled Trials
Official scientific title Effectiveness of Training Program for Parents of Preschool Children With Autism: A Randomized Controlled Trials
Brief summary describing the background and objectives of the trial Literature highlighted that parent’s training program can significantly improve the parent–child relationship, enhance the outcome for children with autism especially increasing the communication skills and decreasing the disruptive behavior. Moreover, parent training improves the quality of life for the family and reduces parental psychological distress. This is an RCT study, it compared a parent’s training program intervention (n=31) and a control sample (n=31) who did not receive any intervention. The study was conducted among parents of children with ASD from 2019 to 2022. The intervention program lasted for 14 months and included eight educational sessions of 120 minutes each over sixteen weeks and 6-months follow-up after the end of the intervention. The program was broadly based on multiple early intervention and cognitive-behavioral techniques and has several purposes.
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,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/11/2019
Actual trial start date 05/03/2021
Anticipated date of last follow up 01/01/2022
Actual Last follow-up date 10/02/2022
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 62
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training program among parent of preschool children with ASD From 2019 to 2022. The intervention program lasted for 14 months and included eight educational sessions of 120 minutes each over sixteen weeks and 6-months follow-up after the end of the intervention. Content of training program: communication Behavior: Understanding and managing difficult behaviour. Principles of positive behaviour support: changing behaviour by manipulating consequences Coping and managing parental stress parents enrolled in the experimental group received eight educational sessions of 120 minutes each over sixteen weeks and 6-months follow-up after the end of the intervention 31
Control Group No Intervention From 2019 to 2022 No intervention received 31 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Parent of a preschool child with ASD. The children are diagnosed with autistic spectrum disorder according to the DSM-V (American Psychiatric Association, 2013). Children aged over 3 years (age at which the diagnosis can be confirmed) and under 7 years old. Children with ASD who are mentally retarded. Parents of a child with ASD who is mentally retarded. Parents with another child with mental retardation or with a disability other than the one with ASD. Parent with psychological disorders before having a child with ASD,  Preschool Child: 2 Year-5 Year 3 Year(s) 7 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 26/07/2021 CEFMS
Ethics Committee Address
Street address City Postal code Country
Mohamed Karoui, Sousse 4002 sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Brief Cope WHOQoL HADS T0: time baseline T1: after the intervention T2: follow up 6 months
Secondary Outcome sociodemographic outcomes parents, children Measures were taken pre- and posttreatment assessment and at 6-month follow-up.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Autism center les colombes Sidi Abdelhamid Sousse Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Nihed Abid Ain mdheker Enfidha Sousse 4095 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor center of autism les colombes sidi abdelhamid sidi abdelhamid sousse Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries SIhem Hmissa hmissa_s@yahoo.fr 21698607323 Facult de medecine
City Postal code Country Position/Affiliation
sousse 4095 Tunisia PhD researcher in Epidemiology of Cancer Research in the Tunisian Center
Role Name Email Phone Street address
Principal Investigator Nihed Abid nihed.abid@gmail.com 0021692360614 Enfidha
City Postal code Country Position/Affiliation
Sousse Tunisia Cytopathology and epidemiology of cancer research unit
Role Name Email Phone Street address
Scientific Enquiries Naoufel Gaddour naoufel.gaddour@rns.tn 0021626473600 Hospital Fattouma Bouguiba
City Postal code Country Position/Affiliation
Monastir Tunisia Child psychiatry Monastir
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data that collected during the trial, after deidentification. Statistical Analysis Plan,Study Protocol Results will be shared in 12 months. Inclusion criteria required participants (a) to have a preschool child aged 3–8 years diagnosed with ASD based on expert evaluation using Diagnostic Statistical Manual - 4th edition (DSM-4) criteria, and received local early intervention services as usual. We required (b) parents above the age of 18, (c) living with their child with ASD, (d) capable of reading and writing in Arabic.
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