UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029467 |
|---|---|
| Receipt number | 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 19:23:48 |
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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
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
fateme.aghaie@yahoo.com
Sponsor or person
Institute
University of Social Welfare and Rehabilitation 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-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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033667
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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