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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029467
Receipt No. R000033667
Scientific Title The Efficacy of Tuning in to Kids Targeting mothers' Emotion style, emotion competence and externalizing behaviors of Preschoolers with behavior problems
Date of disclosure of the study information 2017/10/07
Last modified on 2017/10/07

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Basic information
Public title The Efficacy of Tuning in to Kids Targeting mothers' Emotion style, emotion competence and externalizing behaviors of Preschoolers with behavior problems
Acronym The Efficacy of Tuning in to Kids Targeting mothers and Preschoolers with behavior problems
Scientific Title The Efficacy of Tuning in to Kids Targeting mothers' Emotion style, emotion competence and externalizing behaviors of Preschoolers with behavior problems
Scientific Title:Acronym The Efficacy of Tuning in to Kids Targeting mothers and Preschoolers with behavior problems
Region
Asia(except Japan)

Condition
Condition Disruptive behavioral disorders
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate TIK efficacy on behavior problems in preschool children and parent emotion socialization in mothers of preschool children with behavior problems
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. disruptive behavior problems was assessed using Eybeg's child behavior inventory (ECBI) at pre-intervention, post- intervention, 3 month fallow-up
2. children emotion regulation was assessed using emotion regulation checklist ERC at pre-intervention, post- intervention, 3 month fallow-up
3.parent emotion socialization practices was assessed using the coping with children's negative emotion scale (CCNES) at pre-intervention, post- intervention, 3 month fallow-up
4. maternal emotion style is assessed using Parent Emotional Style Questionnaire (PESQ) at pre-intervention, post- intervention, 3 month fallow-up
Key secondary outcomes 1. parents' emotion regulation was assessed using the Difficulties in Emotion rgulation Scale (DERS) at pre-intervention,post-intervention, 3-month follow-up
2. matrnal self- efficacy was assessed using Parenting Self-Agency Measure (PSAM)
at pre-intervention,post-intervention, 3-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 Intervention group: tuning in to kids program (In 8 weekly sessions, developmental information about preschoolers, problem solving and empathy skills along with emotion regulation in response to children's emotion and mothers' emotion via homework, role plays, books and DVD displays are taught. session are conducted in 4 preschools located in townships of Haft Hoz, Marzdaran, Gish and Shahrara, in Tehran.)

Interventions/Control_2 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 diagnosis of disruptive behavior by screening questionnaire CBCL
Key exclusion criteria diagnosis of pervasive developmental disorders
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fateme Aghaie
Organization University of Social Welfare and Rehabilitation Sciences
Division name Department of clinical psychology
Zip code
Address kodakyar Ave., daneshjo Blvd.,Evin,Post code: 1985713834 ,Tehran, Iran, Islamic Republic Of
TEL +989128185618
Email fateme.aghaie@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Fateme Aghaie
Organization University of Social Welfare and Rehabilitation Sciences
Division name Department of clinical psychology
Zip code
Address kodakyar Ave., daneshjo Blvd.,Evin,Post code: 1985713834 ,Tehran, Iran, Islamic Republic Of
TEL +982122180045
Homepage URL
Email fateme.aghaie@yahoo.com

Sponsor
Institute University of Social Welfare and Rehabilitation 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-forprofit 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 University of Social Welfare and Rehabilitation Sciences

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 07 Day

Related information
URL releasing protocol http://irj.uswr.ac.ir/article-1-733-en.html
Publication of results Partially published

Result
URL related to results and publications http://irj.uswr.ac.ir/article-1-733-en.html
Number of participants that the trial has enrolled
Results
Mothers in the intervention group reported significantly less emotion dismissing beliefs and child behavior problems than controls at 3-month follow-up. there were no significant differences for emotion coaching beliefs and maternal mental health in either condition.
The Tuning in to Kids program appears to be a promising parenting intervention for mothers and children with disruptive behavior problems, offering a useful addition to usual programs used in Iran.
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 02 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 16 Day
Last follow-up date
2016 Year 12 Month 29 Day
Date of closure to data entry
2017 Year 01 Month 19 Day
Date trial data considered complete
2017 Year 02 Month 18 Day
Date analysis concluded
2017 Year 07 Month 15 Day

Other
Other related information Mothers in the intervention condition reported significantly less emotion dismissing behaviors and emotion lability and more emotion coaching behaviors than controls. there were no significant differences for parent emotion regulation in either condition.

Management information
Registered date
2017 Year 10 Month 07 Day
Last modified on
2017 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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