UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052669 |
|---|---|
| Receipt number | R000060107 |
| Scientific Title | The effectiveness a parent group-based resilience program on anxiety and comorbid behavioral problems in children with mental disability and autism |
| Date of disclosure of the study information | 2024/02/20 |
| Last modified on | 2023/11/01 15:04:29 |
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Basic information
Public title
The effectiveness a parent group-based resilience program on anxiety and comorbid behavioral problems in children with mental disability and autism
Acronym
The effectiveness a parent group-based resilience program on anxiety and comorbid behavioral problems in children with mental disability and autism
Scientific Title
The effectiveness a parent group-based resilience program on anxiety and comorbid behavioral problems in children with mental disability and autism
Scientific Title:Acronym
The effectiveness a parent group-based resilience program on anxiety and comorbid behavioral problems in children with mental disability and autism
Region
| Asia(except Japan) | Africa |
Condition
Condition
Mothers of children with mental disability
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Explore the effect of a psychosocial/spiritual intervention program delivered to the mothers of children with mental disability on the anxiety and disordered behaviors of their children
Explore the emotional response of mothers of children with mental disability to a psychosocial/spiritual intervention program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Children's level of anxiety and disruptive behaviors will be measured with the ODD subscale of the Child Symptom Inventory-4 (CSI-4)
Measured at pre, immediately post, and 3 months post treatment.
Key secondary outcomes
Maternal anxiety, loneliness, marital functioning
Measured at pre, immediately post, and 3 months post treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
No treatment
Interventions/Control_2
Mindful parenting based on general MBSR techniques
Interventions/Control_3
Spiritual care involving Islamic based philosophy and techniques
Interventions/Control_4
Mindful parenting based on general MBSR techniques plus Spiritual care involving Islamic based philosophy and techniques
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Literate, use social media, have a smart phone or a PC, and willing to participate.
Key exclusion criteria
Mothers of children with non-mental disabilities, illiterate, non-Arabic speakers, having communication difficulties, refusing to participate, and not completing the survey
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Saeed |
| Middle name | A |
| Last name | Al-dossary |
Organization
University of Ha'il
Division name
Department of Psychology, College of Education
Zip code
1818
Address
Ha'il, Saudi Arabia
TEL
966535366377
s.aldossary@uoh.edu.sa
Public contact
Name of contact person
| 1st name | Amira |
| Middle name | M. |
| Last name | Ali |
Organization
Alexandria University
Division name
Department of Psychiatric Nursing and Mental Health, Faculty of Nursing
Zip code
21527
Address
Edmon Fremon st Smouha, Alexandria , Egypt
TEL
201270666082
Homepage URL
https://www.researchgate.net/profile/Amira-M-Ali
amira.mohali@alexu.edu.eg
Sponsor or person
Institute
University of Ha'il
Institute
Department
Personal name
Saeed A. Al-dossary
Funding Source
Organization
King Salman Center for Disability Research
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Saudi Arabia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Hail Research Ethics Committee
Address
Hail 55473, Saudi Arabia
Tel
966165320699
info@uoh.edu.sa
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
| 2024 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060107
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| Registered date | File name |
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| Registered date | File name |
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