UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029825
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email forough.edrissi@gmail.com

Sponsor
Institute Shahid Beheshti University of Medical Sciences,
Research deputy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034059

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.