UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039066 |
|---|---|
| Receipt number | 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 01:38:31 |
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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
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
moses.ede@unn.edu.ng
Sponsor or person
Institute
University of Nigeria
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044552
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