UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054965
Receipt number R000062755
Scientific Title The relationship between affiliate stigma and quality of life among parents of children with autism spectrum disorder: A systematic review and meta-analysis
Date of disclosure of the study information 2024/07/15
Last modified on 2025/05/17 22:17:42

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Basic information

Public title

The relationship between affiliate stigma and quality of life among parents of children with autism spectrum disorder: A systematic review and meta-analysis

Acronym

The relationship between affiliate stigma and quality of life among parents of children with autism spectrum disorder: A systematic review and meta-analysis

Scientific Title

The relationship between affiliate stigma and quality of life among parents of children with autism spectrum disorder: A systematic review and meta-analysis

Scientific Title:Acronym

The relationship between affiliate stigma and quality of life among parents of children with autism spectrum disorder: A systematic review and meta-analysis

Region

Japan


Condition

Condition

Autism Spectrum Disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the strength and nature of the relationship between affiliate stigma and quality of life in parents of children with autism spectrum disorder.

Basic objectives2

Others

Basic objectives -Others

Psychological mechanisms of affiliate stigma and quality of life will also be investigated.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Electronic database searches use ScienceDirect, PubMed, Web of Science and PsycINFO. Assess the relationship between affiliate stigma and quality of life.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

The following search formulae should be used to target the literature obtained.
#1 Affiliate stigma
#2 Stigma
#3 ASD
#4 Autism spectrum
#5 Asperger's
#6 Autistic disorder
#7 Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Key exclusion criteria

Exclude literature that is not suitable for analysis, such as missing data.

Target sample size



Research contact person

Name of lead principal investigator

1st name Wataru
Middle name
Last name Iida

Organization

The Open University of Japan

Division name

Graduate School of Arts and Sciences

Zip code

261-8586

Address

2-11 Wakaba, Mihama-ku, Chiba City

TEL

043-276-5111

Email

wacharu1214@gmail.com


Public contact

Name of contact person

1st name Wataru
Middle name
Last name Iida

Organization

The Open University of Japan

Division name

Graduate School of Arts and Sciences

Zip code

261-8586

Address

2-11 Wakaba, Mihama-ku, Chiba City

TEL

043-276-5111

Homepage URL


Email

wacharu1214@gmail.com


Sponsor or person

Institute

The Open University of Japan

Institute

Department

Personal name



Funding Source

Organization

The Open University of Japan

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Open University of Japan

Address

2-11 Wakaba, Mihama-ku, Chiba City

Tel

043-276-5111

Email

wacharu1214@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

2024 Year 07 Month 15 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

1996

Results

Affiliate stigma was negatively correlated with quality of life (r = -0.50, 95% CI [-0.58, -0.40]). Heterogeneity was high (I2 = 82.8%). No publication bias was detected. Excluding one impactful study slightly reduced the correlation (r = -0.46) and heterogeneity (I2 = 53.0%).

Results date posted

2025 Year 05 Month 17 Day

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

Completed

Date of protocol fixation

2024 Year 07 Month 15 Day

Date of IRB

2024 Year 07 Month 01 Day

Anticipated trial start date

2024 Year 07 Month 15 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1.search strategy

Literature searches were conducted using the electronic databases ScienceDirect, PubMed, Web of Science, PsycINFO ( ) and Medline ( ). Several combinations of the following search terms and related phrases were used, separated by Boolean operators OR and AND: "affiliate stigma" OR "stigma" AND "ASD" OR "autism spectrum" OR "Asperger's" OR "autistic disorder" OR "pervasive developmental disorder not otherwise specified (PDD-) NOS)" For the purpose of an extensive exploratory search, search terms for stigma variables were not used (e.g. to avoid excluding relevant articles where the relationship between stigma and quality of life was not the focus of the study). The reference lists of included articles were manually screened to identify additional studies.

2.eligibility criteria
Eligibility criteria were: i) published in English; ii) included participants who were caregivers of children with a primary diagnosis of ASD (autism, Asperger syndrome, pervasive developmental disorder); iii) empirical studies that investigated the cross-sectional or longitudinal association between autism parental stigma and quality of life; vi) including at least one quantitative measure investigated; v) published in a peer-reviewed journal; vi) written in English; and vii) published between 2009 and 2024 (limited to dealing with the most recent data). Studies were included in the meta-analysis if there were sufficient data to calculate effect sizes. Intervention studies and controlled trials were included if they reported on the association between stigma and quality of life in parents with autistic children.


Management information

Registered date

2024 Year 07 Month 15 Day

Last modified on

2025 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062755