UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039574
Receipt number 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 2023/03/16 17:31:19

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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 or person

Institute

Kansai University of Welfare Sciences

Institute

Department

Personal name



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

Partially published


Result

URL related to results and publications

https://capmh.biomedcentral.com/articles/10.1186/s13034-021-00389-z

Number of participants that the trial has enrolled

60

Results

60 participants enrolled the study. ANCOVA at six months post-intervention revealed that the interaction between time and group was significant for total scores of TOPSE, GHQ30, and CBCL (TOPSE: F=19.43,p<.001; GHQ: F=11.99,p<.001; CBCL: F=7.29 p<.01). In the intragroup comparison, there was significant improvement only in the intervention group with the total score of TOPSE (p<.001) and CBCL (p<.01). The GHQ scores for the control group worsened (p<.01), whereas the intervention group improved (p<.05).

Results date posted

2023 Year 03 Month 16 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

Main results already published

Date of protocol fixation

2014 Year 06 Month 17 Day

Date of IRB

2014 Year 06 Month 17 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2020 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

2023 Year 03 Month 16 Day



Link to view the page

Value
https://center6.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