UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of Tuning in to Kids on parent emotion socialization, emotional competency and Anxiety symptoms in preschool children with Anxiety disorders
Title of the study (Brief title)	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	Forough Edrissi
Organization	Shahid Beheshti University of Medical Sciences
Division name	Department of clinical psychology
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	Forough Edrissi
Organization	Shahid Beheshti University of Medical Sciences
Division name	Department of clinical psychology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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