UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057272 |
|---|---|
| Receipt number | R000065463 |
| Scientific Title | A group randomized control study for reduction of stress in children with adverse childhood experiences (ACEs): Impact of Rational Emotive Family Health Therapy |
| Date of disclosure of the study information | 2025/03/12 |
| Last modified on | 2025/03/12 21:42:32 |
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Basic information
Public title
A group randomized control study for reduction of stress in children with adverse childhood experiences (ACEs): Impact of Rational Emotive Family Health Therapy
Acronym
A group randomized control study for reduction of stress in children with adverse childhood experiences
Scientific Title
A group randomized control study for reduction of stress in children with adverse childhood experiences (ACEs): Impact of Rational Emotive Family Health Therapy
Scientific Title:Acronym
A group randomized control study for reduction of stress in children with adverse childhood experiences (ACEs)
Region
| Africa |
Condition
Condition
Stress in children with adverse childhood experiences
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the effect of Rational Emotive Family Health Therapy in reducing stress in children with irrational behaviors stemming from adverse childhood experiences (ACEs).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Childhood Stress Scale
Adverse Childhood Experience-Questionnaire
Key secondary outcomes
Nothing
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
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention consisted of 12 sessions over 12 weeks, with one session per week lasting an hour. Time refers to the hour or hours for each session, including the assessment hour, practice exercise, and activities.
Interventions/Control_2
The control group members did not receive intervention
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
| 7 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Having experienced any ACE as measured by self-reports measures
2. Willingness to participate in the study
3. Verbalization of stress
4. Acting irritability
5. Complaining more than usual about school
6. Readily available throughout the period of the study
Key exclusion criteria
1. Receiving other psychological treatment from a psychologist/counsellor
2. Being under diagnostic processes with a pharmacologist
3. Declining to submit the content form, or orally withdrawing consent
4. Absence of adverse childhood experience
5. Being outside the age bracket
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Clara |
| Middle name | Onyemaechi |
| Last name | Ifelunni |
Organization
University of Nigeria, Nsukka
Division name
University
Zip code
410001
Address
Fafunwa Building
TEL
+2348038792435
onyemaechi.moses@gmail.com
Public contact
Name of contact person
| 1st name | Moses |
| Middle name | Onyemaechi |
| Last name | Ede |
Organization
University of Nigeria
Division name
University
Zip code
410001
Address
Faculty of Education, University of Nigeria
TEL
+2347066725165
Homepage URL
https://www.unn.edu.ng/
onyemaechi.moses@gmail.com
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
University of Nigeria
Tel
+2347056928475
onyemaechi.moses@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
No URL
Publication of results
Unpublished
Result
URL related to results and publications
No URL
Number of participants that the trial has enrolled
104
Results
The results indicated that Rational Emotive Family Health Therapy had a significant effect on stress scores of Nigerian school children with adverse childhood experiences compared to those in the no-intervention group.
Results date posted
| 2025 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
High level of stress
Participant flow
52 participant for treatment group
52 participant for no-contact control group
Adverse events
Minimal adverse effect
Outcome measures
Childhood Stress Scale
Adverse Childhood Experiences-Questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 02 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 25 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065463
