UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029825 |
|---|---|
| Receipt number | R000034059 |
| Scientific Title | The effectiveness of Tuning in to Kids on parent emotion socialization, emotional competency and Anxiety symptoms in preschool children with Anxiety disorders |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2017/11/05 05:00:09 |
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Basic information
Public title
The effectiveness of Tuning in to Kids on parent emotion socialization, emotional competency and Anxiety symptoms in preschool children with Anxiety disorders
Acronym
Effects of tuning into kids program on mothers and Preschoolers with anxiety problems
Scientific Title
The effectiveness of Tuning in to Kids on parent emotion socialization, emotional competency and Anxiety symptoms in preschool children with Anxiety disorders
Scientific Title:Acronym
Effects of tuning into kids program on mothers and Preschoolers with anxiety problems
Region
| Asia(except Japan) |
Condition
Condition
anxiety disorders
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine TIK effectiveness on anxiety problems in preschool children and parent emotion socialization in mothers of preschool children with anxiety problems
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. preschool anxiety problems were assessed The Preschool Anxiety Scale (PAS) at pre-intervention, post-intervention, 6-month follow-up
2. children emotion regulation was assessed using emotion regulation checklist ERC at pre-intervention, post-intervention, 6-month follow-up
3.parent emotion socialization practices were assessed using the coping with children's negative emotion scale (CCNES) at pre-intervention, post-intervention, 6-month follow-up
4. maternal emotion style is assessed using Parent Emotional Style Questionnaire (PESQ) at pre-intervention, post-intervention, 6-month follow-up
Key secondary outcomes
1. parents' emotion regulation was assessed using the Difficulties in Emotion Regulation Scale (DERS) at pre-intervention,post-intervention, 6-month follow-up
2. maternal self- efficacy was assessed using Parenting Self-Agency Measure (PSAM)
at pre-intervention,post-intervention, 6-month follow-up
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mothers in the intervention group received 8 sessions TIK weekly. They were taught developmental information about preschoolers, emotion coaching parenting and empathy skills through homework, role play, books and DVD displays. Sessions were conducted in 4 neighborhood houses were located in regions of Haft Hoz, Marzdaran, Gisha, and Shahrara, in Tehran.
Control: waiting list for 8- session tuning in to kids program after data collection ended
Interventions/Control_2
Mothers in the intervention group received 8 sessions TIK weekly. They were taught developmental information about preschoolers, emotion coaching parenting and empathy skills through homework, role play, books and DVD displays. Sessions were conducted in 4 neighborhood houses were located in regions of Haft Hoz, Marzdaran, Gisha, and Shahrara, in Tehran.
Control: waiting list for 8- session tuning in to kids program after data collection ended
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
| 3 | years-old | < |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
receiving the diagnosis of anxiety problems with The Preschool Anxiety Scale (PAS)
Key exclusion criteria
diagnosis of pervasive developmental disorders
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Forough Edrissi |
Organization
Shahid Beheshti University of Medical Sciences
Division name
Department of clinical psychology
Zip code
Address
Talegani Educational Hospital, Tabnak St. , Velenjak Region, Chamran High Way, Tehran, Iran
TEL
982123031548
forough.edrissi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Forough Edrissi |
Organization
Shahid Beheshti University of Medical Sciences
Division name
Department of clinical psychology
Zip code
Address
Talegani Educational Hospital, Tabnak St. , Velenjak Region, Chamran High Way, Tehran, Iran
TEL
9893734049008
Homepage URL
forough.edrissi@gmail.com
Sponsor or person
Institute
Shahid Beheshti University of Medical Sciences,
Research deputy
Institute
Department
Personal name
Funding Source
Organization
this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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
Address
Tel
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
Shahid Beheshti University of Medical Sciences
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 20 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 05 | Day |
Last modified on
| 2017 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034059
