UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056113 |
|---|---|
| Receipt number | R000064116 |
| Scientific Title | Adaptation of SOLACE program and its efficacy to reduce effects of stigma on mental health of parents of children with autism spectrum disorders |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2024/11/11 02:04:29 |
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Basic information
Public title
Adaptation of SOLACE program and its efficacy to reduce effects of
stigma on mental health of parents of children with autism spectrum
disorders: A Randomized Controlled Trial.
Acronym
Randomized Controlled Trial, Efficacy, Stigmatization protection program for parents, Autism Spectrum Disorder, mental health
Scientific Title
Adaptation of SOLACE program and its efficacy to reduce effects of
stigma on mental health of parents of children with autism spectrum
disorders
Scientific Title:Acronym
Randomized Controlled Trial, Efficacy, Stigmatization protection program for parents, Autism Spectrum Disorder, mental health
Region
| Asia(except Japan) |
Condition
Condition
Reduction in the level of self-stigma, social stigma, depression, anxiety,
stress and improvement in social support, self-esteem and self-compassion in parents of
children with ASD
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To review indigenous literature on stigma, its misconception, myths, impact and coping
in cultural context in mothers of children with ASD to find out unique cultural aspects.
2. To adapt SOLACE from phase I.
3. To find out efficacy of adapted SOLACE program to combat stigma in parents of
children with ASD through RCT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the efficacy of SOLACE program and to reduce effects of stigma on mental health of mothers of children with autism spectrum disorders(ASD). The measurement tools would be DASS(Lovibond & Lovibond, 1995), Perceived Autism Related Stigma by Association Scale (Rizwi & Batool, 2020),Perceived Courtesy Stigma Scale (PCSS) (Chan & Lam 2017),Self-esteem scale, Positive Meaning of Caregiving, Self-compassion Scale, Social support. This outcome will be measured within 4 months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Experimental group will receive SOLACE program to reduce the effects of stigma on mental health of mothers of children with autism spectrum disorders (ASD). This group will receive education about SOLACE program in about 10 sessions(only mothers will be given 8 sessions and Fathers will be given 2 sessions). Each session will be approximately 60-90 minutes.
Interventions/Control_2
Control group -1 will receive no treatment.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who have received diagnosed of their child 1-2 year ago.
2. Whose children are mild to moderate on spectrum (pre-diagnosed).
3. Screened out mothers having moderate to high level of stigma on Perceived Autism
Related Stigma by Association Scale (Rizwi & Batool, 2020) will be selected.
4. Having access to the internet.
5. Having familiarity with mobile usage.
6. Having social media accounts like WhatsApp and Facebook will be recruited.
7. Having intact marriages.
8. Whose spouses are also available and give consent for sessions.
9. Mothers from Lahore.
Key exclusion criteria
1. Having an ASD child with comorbid conditions.
2. Having more than one diagnosed ASD child.
3. Who have been diagnosed with severe psychiatric illness themselves.
4. Divorced/single mother
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fatima |
| Middle name | Salman |
| Last name | Qazi |
Organization
Centre for Clinical Psychology, University of the Punjab, Lahore, Punjab, Pakistan
Division name
Lahore, Punjab, Pakistan
Zip code
54590
Address
F7H8+HFV, Canal Rd, Quaid-i-Azam Campus, Lahore, Punjab
TEL
03224081556
fatima.qazi264@gmail.com
Public contact
Name of contact person
| 1st name | Fatima |
| Middle name | Salman |
| Last name | Qazi |
Organization
Centre for Clinical Psychology, University of the Punjab, Lahore, Punjab, Pakistan
Division name
Lahore, Punjab, Pakistan
Zip code
54590
Address
F7H8+HFV, Canal Rd, Quaid-i-Azam Campus, Lahore, Punjab
TEL
042-99230533
Homepage URL
https://pu.edu.pk/home/department/45
info.ccpsy@pu.edu.pk
Sponsor or person
Institute
Centre for Clinical Psychology, University of the Punjab, Lahore, Punjab, Pakistan
Institute
Department
Personal name
Funding Source
Organization
Self-funded
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
Centre for Clinical Psychology, University of the Punjab, Lahore, Punjab, Pakistan
Address
F8V2+V96, Quaid-i-Azam Campus, Lahore, Punjab
Tel
042-99230533
info.ccpsy@pu.edu.pk
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 | 05 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064116
