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

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 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


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

Value
https://center6.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