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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000029467
受付番号 R000033667
科学的試験名
一般公開日(本登録希望日) 2017/10/07
最終更新日 2017/10/07

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
The Efficacy of Tuning in to Kids Targeting mothers' Emotion style, emotion competence and externalizing behaviors of Preschoolers with behavior problems
一般向け試験名略称/Acronym
The Efficacy of Tuning in to Kids Targeting mothers and Preschoolers with behavior problems
科学的試験名/Scientific Title
The Efficacy of Tuning in to Kids Targeting mothers' Emotion style, emotion competence and externalizing behaviors of Preschoolers with behavior problems
科学的試験名略称/Scientific Title:Acronym
The Efficacy of Tuning in to Kids Targeting mothers and Preschoolers with behavior problems
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Disruptive behavioral disorders
疾患区分1/Classification by specialty
小児科学/Pediatrics 精神神経科学/Psychiatry
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
to evaluate TIK efficacy on behavior problems in preschool children and parent emotion socialization in mothers of preschool children with behavior problems
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/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
副次アウトカム評価項目/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

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
行動・習慣/Behavior,custom
介入1/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.)

介入2/Interventions/Control_2
Control: waiting list for 8- session tuning in to kids program after data collection ended.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
3 歳/years-old より上/<
年齢(上限)/Age-upper limit
6 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
receiving diagnosis of disruptive behavior by screening questionnaire CBCL
除外基準/Key exclusion criteria
diagnosis of pervasive developmental disorders
目標参加者数/Target sample size 54

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム


ミドルネーム
Fateme Aghaie
所属組織/Organization
University of Social Welfare and Rehabilitation Sciences
所属部署/Division name
Department of clinical psychology
郵便番号/Zip code
住所/Address
kodakyar Ave., daneshjo Blvd.,Evin,Post code: 1985713834 ,Tehran, Iran, Islamic Republic Of
電話/TEL +989128185618
Email/Email fateme.aghaie@yahoo.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム


ミドルネーム
Fateme Aghaie
組織名/Organization
University of Social Welfare and Rehabilitation Sciences
部署名/Division name
Department of clinical psychology
郵便番号/Zip code
住所/Address
kodakyar Ave., daneshjo Blvd.,Evin,Post code: 1985713834 ,Tehran, Iran, Islamic Republic Of
電話/TEL +982122180045
試験のホームページURL/Homepage URL
Email/Email fateme.aghaie@yahoo.com

実施責任組織/Sponsor
機関名/Institute その他 University of Social Welfare and Rehabilitation Sciences,
Research deputy
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 this research did not receive any specific grant from funding agencies in the public, commercial, or not-forprofit sectors.
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions University of Social Welfare and Rehabilitation Sciences

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2017 10 07

関連情報/Related information
プロトコル掲載URL/URL releasing protocol http://irj.uswr.ac.ir/article-1-733-en.html
試験結果の公開状況/Publication of results 中間解析等の途中公開/Partially published

結果/Result
結果掲載URL/URL related to results and publications http://irj.uswr.ac.ir/article-1-733-en.html
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/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.
主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2015 09 02
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2016 06 16
フォロー終了(予定)日/Last follow-up date
2016 12 29
入力終了(予定)日/Date of closure to data entry
2017 01 19
データ固定(予定)日/Date trial data considered complete
2017 02 18
解析終了(予定)日/Date analysis concluded
2017 07 15

その他/Other
その他関連情報/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.

管理情報/Management information
登録日時/Registered date
2017 10 07
最終更新日/Last modified on
2017 10 07


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033667
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033667

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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