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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039066
Receipt No. R000044552
Scientific Title Rational Emotive Family Health Therapy for reducing Parenting Stress in Families of Children with Autism Spectrum Disorders: A group randomized control study
Date of disclosure of the study information 2020/01/07
Last modified on 2020/01/07

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Basic information
Public title Rational Emotive Family Health Therapy for reducing Parenting Stress in Families of Children with Autism Spectrum Disorders: A group randomized control study
Acronym REFHT for Parenting Stress in Families of Children with ASDs
Scientific Title Rational Emotive Family Health Therapy for reducing Parenting Stress in Families of Children with Autism Spectrum Disorders: A group randomized control study
Scientific Title:Acronym REFHT for Parenting Stress in Families of Children with ASDs
Region
Africa

Condition
Condition Parenting Stress in Families of Children with ASDs
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study sought to examine the effect of rational emotive family health therapy (REFHT) on parenting stress among parents of children with autism spectrum disorders in Ebonyi state Nigeria.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Parental Stress Scale At Time 1, Time 2 and Time 3
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Rational emotive family health programme (REFHP)onsisted of 12 sessions that lasted for 12 weeks.
Interventions/Control_2 The no-contact group did not receive any form of contact or intervention other than the administration of the measures and was not offered access to REFHP after the active phase of the study.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
35 years-old <=
Age-upper limit
58 years-old >=
Gender Male and Female
Key inclusion criteria 1) parents of children with ASDs clinically diagnosed in accordance with the Diagnostic Statistical Manual of Mental Disorder-V (DSM-V) (APA, 2013), 2) showing and verifying the email addresses of the parents, and 3) possession of functional mobile phone.
Key exclusion criteria Parents receiving treatment from psychologists, pharmacologists, mental health therapists, family counsellors, psychiatrists or any medications from other helping professionals were excluded from the study.
Target sample size 128

Research contact person
Name of lead principal investigator
1st name Moses
Middle name Onyemaechi
Last name Ede
Organization University of Nigeria
Division name Department of Educational Foundations
Zip code 410001
Address Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
TEL +2347066725165
Email moses.ede@unn.edu.ng

Public contact
Name of contact person
1st name Moses
Middle name Onyemaechi
Last name Ede
Organization University of Nigeria, Nsukka
Division name Department of Educational Foundations
Zip code 410001
Address Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Educatio
TEL +2347066725165
Homepage URL
Email moses.ede@unn.edu.ng

Sponsor
Institute University of Nigeria
Institute
Department

Funding Source
Organization University of Nigeria
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Nigeria
Address Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
Tel +2347066725165
Email moses.ede@unn.edu.ng

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions University of Nigeria

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 07 Day

Related information
URL releasing protocol Not applicable
Publication of results Unpublished

Result
URL related to results and publications Not applicable
Number of participants that the trial has enrolled 128
Results
Result reveales that there was no significant difference between the treatment and no-contact control groups in initial parenting stress among parents of children with autism spectrum disorders. 
Results date posted
2020 Year 01 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gender (fathers and mothers of the same children expect single parents, particularly mothers), educational attainment, occupation, family size and length of time parents have lived with a child having ASD among others.
Participant flow
N/A
Adverse events
There was no adverse events
Outcome measures
Parental Stress Scale (PSS) 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 04 Day
Date of IRB
2014 Year 07 Month 06 Day
Anticipated trial start date
2015 Year 12 Month 14 Day
Last follow-up date
2016 Year 09 Month 09 Day
Date of closure to data entry
2016 Year 11 Month 05 Day
Date trial data considered complete
2017 Year 02 Month 12 Day
Date analysis concluded
2017 Year 03 Month 16 Day

Other
Other related information

Management information
Registered date
2020 Year 01 Month 07 Day
Last modified on
2020 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044552

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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