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The Efficacy of Tuning in to Kids Targeting parents' Emotion style, emotion competence and externalizing behaviors of Preschoolers with behavior problems

Protocol summary

Summary
Tuning into Kids (TIK) program aims to improve mothers’ emotion style by focusing on mothers’ emotional beliefs and behaviors. This study aims to evaluate efficacy of TIK on mothers and children aged 4.0–6.0 years with behavior problems. This is a semi-experimental pretest- post study with a control group. Three to six- year- old children who attended in preschools in Tehran (2016) were screened by CBCL for behavior problems. Children with autism spectrum disorders and mental retardation were exclude. Fifty mothers who met the criteria and were interested in participating in the study were randomized into intervention (TIK) or waiting list control. Mothers in intervention group receive 8 session TIK weekly. in the intervention 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 play, books and DVD displays are taught.session are conducted in 4 preschools located in townships of Haft Hoz, Marzdaran, Gish and Shahrara, in Tehran. Mothers report maternal Emotion style, mental health, self-efficacy, difficulties in emotion regulation, disruptive behavior problems and children emotion regulation in pre-intervention, post-intervention, 3-month follow-up. Data will analyze using ANCOVA.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061034444N1
Registration date: 2017-06-25, 1396/04/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-25, 1396/04/04
Registrant information
Name
Fateme Aghaie
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 1415
Email address
fa.aghaie@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2016-07-03, 1395/04/13
Expected recruitment end date
2016-12-29, 1395/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Tuning in to Kids Targeting parents' Emotion style, emotion competence and externalizing behaviors of Preschoolers with behavior problems
Public title
Effects of tuning into kids program on mothers and Preschoolers with behavior problems
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: receiving diagnosis of disruptive behavior by screening questionnaire CBCL and T score ≥ 65; child age is 3 to 6 years old. Exclusion criteria: diagnosis of Autism spectrum disorders or mental retardation.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin,Post code: : 1985713834
City
Tehran
Postal code
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
IR.USWR.REC.13940221

Health conditions studied

1

Description of health condition studied
Disruptive behavioral disorders
ICD-10 code
F98.9
ICD-10 code description
Unspecified behavioural and emotional disorders with onset usually occurring in childhood and adolescence

Primary outcomes

1

Description
disruptive behavior problems
Timepoint
pre-intervention, post- intervention, 3 month fallow-up
Method of measurement
Eybeg's child behavior inventory (ECBI)

2

Description
children emotion regulation
Timepoint
pre-intervention, post- intervention, 3 month fallow-up
Method of measurement
emotion regulation checklist ERC

Secondary outcomes

1

Description
maternal emotion style
Timepoint
pre-intervention,post-intervention, 3-month follow-up
Method of measurement
Parent Emotional Style Questionnaire (PESQ)

2

Description
difficulties in emotion regulation
Timepoint
pre-intervention,post-intervention, 3-month follow-up
Method of measurement
Difficulties in Emotion Egulation Scale (DERS)

3

Description
matrnal self- efficacy
Timepoint
pre-intervention,post-intervention, 3-month follow-up
Method of measurement
Parenting Self-Agency Measure (PSAM)

4

Description
mental health
Timepoint
pre-intervention,post-intervention, 3-month follow-up
Method of measurement
General Health Questionnaire (GHQ-28)

Intervention groups

1

Description
Intervention group: tuning in to kids program (In 8 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.)
Category
Treatment - Other

2

Description
Control: waiting list for 8- session tuning in to kids program after data collection ended.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Preschool located in Marzdaran
Full name of responsible person
Miss Panahi
Street address
Marzdaran, After Azmayesh bridge, Jalale Ale Ahmad highway
City
Tehran

2

Recruitment center
Name of recruitment center
Preschool of Haft Hoz
Full name of responsible person
Miss Fallah
Street address
Haft Hoz, West Janbazan St, Nabovat Square
City
Tehran

3

Recruitment center
Name of recruitment center
Preschool located in Gisha
Full name of responsible person
Miss Salavati
Street address
20th Avenue, Gisha Street
City
Tehran

4

Recruitment center
Name of recruitment center
Preschool of Shahrak Shahrara
Full name of responsible person
Miss Sohrabi
Street address
Next to Shahrara park, Shahrara
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Hamiddreza Khankeh
Street address
Research deputy, Next to central library, University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Grant name
ندارد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Fateme Aghaie
Position
PhD student
Other areas of specialty/work
Street address
clinical psychology department, kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 6694 1415
Fax
Email
fateme.aghaie@yahoo.com; fa.aghaie@uswr.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Parvaneh Mohammadkhani
Position
Professor
Other areas of specialty/work
Street address
department of clinical psychology, university of social welfare and rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin,
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0045
Fax
Email
parmohamir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Fateme Aghaie
Position
PhD student
Other areas of specialty/work
Street address
department of clinical psychology, university of welfare and rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
Phone
Fax
Email
fa.aghaie@uswr.ac.ir; fatme.aghaie@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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