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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039574
Receipt No. R000045132
Scientific Title Effects of an Attachment-Based Parent Intervention on Children with Autism Spectrum Disorders
Date of disclosure of the study information 2020/02/23
Last modified on 2020/10/13

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Basic information
Public title Effects of an Attachment Based Parent Intervention on Children with Autism Spectrum Disorders: Nonrandomized Clinical Trial
Acronym Effects of an Attachment-Based Parent Intervention on Children with Autism Spectrum Disorders
Scientific Title Effects of an Attachment-Based Parent Intervention on Children with Autism Spectrum Disorders
Scientific Title:Acronym Effects of an Attachment-Based Parent Intervention on Children with Autism Spectrum Disorders
Region
Japan

Condition
Condition Autism spectrum disorders (ASD)
Classification by specialty
Pediatrics Psychiatry Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to test the efficacy of COSP with caregivers of children with ASD by investigating changes in caregivers' parenting efficacy, their psychological/physical states, and behavioral and emotional problems of children with ASD. This is a nonrandomized study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Tool to Measure Parenting Self-Efficacy Japanese version (TOPSE)
-General Health Questionnaire 30 (GHQ)
-Child Behavior Checklist 4-18 (CBCL)
Outcomes at 6 months and 1 year after the intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 - The COSP sessions is held weekly and lasted 90 min in duration.
- Groups of four caregivers meet with a single facilitator.
- Sessions are administered by the facilitator following a manual.
- COSP combines psychoeducation about attachment in the form of viewing videos of parent-child interactions with reflection about how each caregiver experiences his/her relationship with his/her child.
- The facilitator encourages participating caregivers to engage in reflective dialogue; the goal is to support caregivers to share their thoughts and emotions about their children's needs and about their own strengths and struggles in meeting those needs.
Interventions/Control_2 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
4 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Children with ASD
1) Children who were diagnosed with ASD based on DSM-5 by psychiatrists.
2) Children aged 4-12 years at the time of participating the study

Caregivers of Children with SD
1) Caregivers of children with ASD aged 4-12 years at the time of participating the study.
2) Caregivers who are able to participate in 8 COSP sessions consecutively.
3) Caregivers who were well briefed orally and in writing about the purpose of the study and confidentiality related to their personal information and provided their voluntary written consent.
Key exclusion criteria Children with ASD
1) Children who have participated in COSP before participating to the study.
2) Children receiving 90 min total or more per week of intensive autism intervention therapy or psychotherapy, or if they began or changed a pharmacotherapeutic regimen during the study period.

Caregivers of Children with ASD
1) Caregivers with a mental illness or developmental disability, or who had been reported to the juvenile welfare officer for perpetrating severe child abuse.
2) Caregivers who have participated in COSP before participating to the study.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Nobuyo
Middle name
Last name Kubo
Organization Kansai University of Welfare Sciences
Division name School of Psychological Science
Zip code 582-0026
Address 3-11-1 Asahigaoka, Kashiwara-shi, Osaka 582-0026 Japan
TEL 072-978-0088
Email kubo@tamateyama.ac.jp

Public contact
Name of contact person
1st name Nobuyo
Middle name
Last name Kubo
Organization Kansai University of Welfare Sciences
Division name School of Psychological Science
Zip code 582-0026
Address 3-11-1 Asahigaoka, Kashiwara-shi, Osaka 582-0026 Japan
TEL 072-978-0088
Homepage URL
Email kubo@tamateyama.ac.jp

Sponsor
Institute Kansai University of Welfare Sciences
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research(C)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kansai University of Welfare Sciences
Address 3-11-1 Asahigaoka, Kashiwara-shi, Osaka 582-0026 Japan
Tel 072-978-0088
Email ikejima@tamateyama.ac.jp

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 関西福祉科学大学 心理・教育相談センター

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 23 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 20
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 No longer recruiting
Date of protocol fixation
2014 Year 06 Month 17 Day
Date of IRB
2014 Year 06 Month 17 Day
Anticipated trial start date
2020 Year 02 Month 23 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 23 Day
Last modified on
2020 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045132

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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