UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061107 |
|---|---|
| Receipt number | R000069929 |
| Scientific Title | The effectiveness of Family Health Therapy in treating psychological distress of Mothers with autistic children |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/31 00:48:56 |
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Basic information
Public title
The effectiveness of Family Health Therapy in treating psychological distress of Mothers with autistic children
Acronym
Family Health Therapy for treating psychological distress
Scientific Title
The effectiveness of Family Health Therapy in treating psychological distress of Mothers with autistic children
Scientific Title:Acronym
Family Health Therapy for treating psychological distress
Region
| Africa |
Condition
Condition
Psychological distress
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated the effectiveness of Family Health Therapy in treating psychological distress of Mothers with autistic children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Perceived emotional distress inventory
Key secondary outcomes
Parent Irrational Beliefs Scale
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants in the intervention group were exposed to 12-session REFHT treatment program
Interventions/Control_2
Participants in the control group were not exposed to 12-session REFHT treatment program but waitlisted.
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
| 25 | years-old | < |
Age-upper limit
| 68 | years-old | > |
Gender
Female
Key inclusion criteria
High psychological distress
Key exclusion criteria
No psychological distress
Target sample size
89
Research contact person
Name of lead principal investigator
| 1st name | Grace |
| Middle name | Ngozi |
| Last name | Omeje |
Organization
University of Nigeria
Division name
University
Zip code
410001
Address
Room 23 Fafunwa Building, Educational Foundations, Faculty of Education, University of Nigeria
TEL
+2347066725165
grace.omeje@unn.edu.ng
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
Room 23 Fafunwa Building, Educational Foundations, 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
Moses Ede
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
+2347066725165
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
| 2026 | Year | 03 | Month | 31 | 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
89
Results
The findings showed that FHT had a significant impact in decreasing the high level of parental distress
Results date posted
| 2026 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
No delay
Date of the first journal publication of results
Baseline Characteristics
High psychological distress
Participant flow
44 participants in the treatment group
45 participants in the control group
Adverse events
No adverse effect
Outcome measures
Perceived Emotional Distress Inventory
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 07 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069929
