UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053643 |
|---|---|
| Receipt number | R000061221 |
| Scientific Title | Acceptance and commitment therapy on family adaptation and parent-child relationships in mothers of children with autism disorder |
| Date of disclosure of the study information | 2024/02/19 |
| Last modified on | 2024/02/19 06:55:12 |
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Basic information
Public title
Investigate the effect Acceptance and commitment therapy on family adaptation and parent-child relationships in mothers of children with autism disorder
Acronym
Acceptance and commitment therapy on family adaptation and parent-child relationships in mothers of children with autism disorder
Scientific Title
Acceptance and commitment therapy on family adaptation and parent-child relationships in mothers of children with autism disorder
Scientific Title:Acronym
ACT on family adaptation and parent-child relationships in mothers of children with autism disorder
Region
| Asia(except Japan) |
Condition
Condition
Acceptance and commitment therapy on family adaptation and parent-child relationships in mothers of children with autism disorder
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Autism spectrum disorder (ASD), characterized by deficits in social communication and the presence of restricted, repetitive behaviors or interests, is a neurodevelopmental disorder affecting approximately 2.3% children aged 8 years in the US and approximately 2.2% of adults. This study examined acceptance commitment therapy (ACT) on family adaptation and parent-child relationships in mothers of children with autism spectrum disorder (ASD) in Yazd, Iran.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the results showed acceptance commitment therapy have a positive effect on child- parent relationship and increase the family adaption in mothers of children with ASD.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
An ACT protocol for parents developed by Prevedini and et.at (2021) was used with the intervention group. this protocol consists of 12 sessions, each with specific goals. In ACT emphasis is pit on establishing of context for acceptance, followed by commitment to values and action as the main psychological process. The purpose of the first session was psycho-education and familiarity with treatment. In the second and third sessions, the emphasis was placed on establishing a framework for acceptance for treatment through evaluation and cost estimation of past control efforts and creating a space for new solutions, acceptance, or willingness to change. The goal was focusing on reduction of avoidance. The fourth and fifth sessions focused on acceptance and value-based life as an alternative to managing anxiety. The goal was increasing acceptance of emotions, feelings and sensations. The purpose of the sixth and seventh session was to create a pattern of behavior through value-based exposures. The goal was commitment to behavior change. The seventh session dealt with commitment to values and action. In the final session, the treatment sessions were reviewed and clients were prepared for recurrence and failure. Various assignments and exercises in sessions were tailored to the needs of the patients, such as mindfulness, life-enhancing, and practicing.
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
| 25 | years-old | <= |
Age-upper limit
| 54 | years-old | >= |
Gender
Female
Key inclusion criteria
(a) be free of any physical and psychological disorder, (b) were in the range of 25- 54 years old, (c) can follow the steps of treatment, (d) no substance abuse or alcohol abuse.
Key exclusion criteria
unwillingness to attend continuing treatment sessions and simultaneous enrollment on another treatment program
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Farangis |
| Middle name | |
| Last name | Demehri |
Organization
science and arts university
Division name
Yazd
Zip code
8915813130
Address
shohadayegomnam Blvd
TEL
0983538207180
farangis_demehri@yahoo.com
Public contact
Name of contact person
| 1st name | Mohammad |
| Middle name | |
| Last name | Zarezadegan |
Organization
Science and Arts University
Division name
Yazd
Zip code
8915813130
Address
shohadayegomnam Blvd
TEL
0983538207180
Homepage URL
demehri@sau.ac.ir
Sponsor or person
Institute
This research has not received any financial support
Institute
Department
Personal name
Funding Source
Organization
This research has not received any financial support
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
Academic Center for Education
Address
Mashhad
Tel
985131997000
Ethics@acecr.ac.ir
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 | 19 | 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
| 2023 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 11 | 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 | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061221
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