UMIN-CTR Clinical Trial

Basic information
Public title	Investigating the effects of Parent Training for mothers of children with ADHD and its effect on parental stress- A randomised control trial
Acronym	Parent training study
Scientific Title	Investigating the effects of Parent Training for mothers of children with ADHD and its effect on parental stress- A randomised control trial
Scientific Title:Acronym	Effects of Parent Training on parental stress for mothers of children with ADHD- RCT
Region	Japan

Condition
Condition	Children diagnosed with attention-deficit hyperactivity disorder (ADHD) and their mothers
Classification by specialty	Pediatrics Psychiatry Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigating the effects of Parent Training on parental stress for mothers of children with ADHD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of Parental Stress Index Total score(percentile) after intervention(10W)
Key secondary outcomes	- Stability of the child's attachment style: Level of security (emotional openness, Balance of positive and negative references, Use of examples,Resolution of conflicts within response, Overall coherence) and Level of insecurity (preoccupied anger, idealization, dismissal) from the Child Attachment Interview - MRI signal (T1-weighted image, Diffusion Weighted Tensor Imaging, resting functional MRI image). - Positive and Negative affect scores of the Positive and Negative affect Schedule for Children - Stability of the child's attachment: KSS - Child's problem behaviours: CBCL - Child's depressive symptoms: DSDRQ - Parenting: PPI-P - Parenting: PPI-C - Child's reward and punishment sensitivity: SPSRQ-C - Child's ADHD symptoms: ADHD-RS, SNAP - Child's QOL: KINDL - Measure of the Child's Social Network: number, quality - Measure of the Parent's social network: number & quality

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	[Parent Training] - 2 psychologists or doctors will conduct the manualised 100 mins behavioural parent training sessions administered over 10 sessions. - Participating mothers will attend the session in groups of 3-6. - Behavioural Parent Training [BPT] is based on that of Barkley [42, 43], Forehand and McMahon [44] and Whitham [45], modified to suit the Japanese culture. - Parent Training allows the adjustment of the environment and sets rules. Through role plays, it teaches the mothers how they could intervene when potential problem behaviours occur. It encourages the application of the taught techniques in the home environment through homeworks and summary sheets. The BPT Manual consists of the following chapters: Step 1: Divide the behaviour into 3 components. Step 2: Attend to the desirable behaviour Step 3: Make "praising" a habit Step 4: Ignore undesirable behaviours Step 5: Make plans to "ignore" Step 6: How to give effective instructions Step 7: How to make reward charts Step 8: Implementing reward charts and setting boundaries Step 9: Adjusting the environment Step 10: Review - The therapists and the researcher will monitor the quality of the sessions through reviewing the recorded videos or sitting in on the sessions. - To prevent drop-outs, personal training will be arranged for those who had missed up to 3 sessions so that they can catch up the missed contents and return to the group program.
Interventions/Control_2	control group - treatment as usual
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	8 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	ADHD children: 1) A diagnosis of ADHD based on DSM-V by a child psychiatrist and scoring higher than 80th percentile on the ADHD-RS (Tanaka et al, 2016) (For children with a current diagnosis of ADHD who are on medication, the symptoms will be assessed whilst on medication) 2) At the time of participation, aged between 8-12. 3) No intellectual delays. Score equal to or higher than 70 on the WISC-IV. 4)Includes those with co-morbid oppositional-defiant disorder, behavioural disorder, tic disorder, learning disorder as well as those with minor anxiety disorder or emotional disorders. 5)Following a detailed explanation of the study, those who are well-informed and provide voluntary written consent. 6) Obtained permission to participate in the research from the attending physician. Mother of ADHD Children: 1) Equal to or above the age of 20 and less than 60 years of age. 2) Mother of a child with a diagnosis of ADHD. 3) Those who can reliably participate in the 10 training sessions as well as the psychological assessment. 4) Those who are able to communicate in Japanese. 5) Those who can visit the University of Tokyo Hospital and Research related facilities during the research period and has a contactable phone number or an email address.
Key exclusion criteria	ADHD children: 1) Those with Severe Autism Spectrum Disorder (assessed to be severely Autistic on the CARS) 2) Comorbid diagnosis of schizophrenia or bi-polar disorder. 3) Suffering from delays in intellectual development (IQ less than 70). 4) Those who require immediate pharmacological treatment for depression, intense anxiety, tension and/or agitation. 5) Those who are intending to participate, or have already completed or currently participating in a psychological/social intervention (psychotherapy, behavioral therapy, cognitive behavioral therapy, etc.) at the time of participation to the study. 6) Those who are deemed unfit to participate by the medical practitioner responsible for the research. Mother of ADHD Children: 1) Those who are presenting with schizophrenia, bi-polar disorder, serious alcohol dependence or drug dependence. 2) Those who require immediate pharmacological intervention for depression, high levels of anxiety, tension or agitation. 3) Those who are intending to participate, have already completed or currently participating in another psychological/social intervention (psychotherapy, behavioral therapy, cognitive behavioral therapy, etc.) at the time of participation to the study. 4) Those who scored under 70 on the JART. 5)Those who are deemed unfit to participate by the medical practitioner responsible for the research.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Ayaka Middle name Last name Ishii
Organization	University of Tokyo Hospital
Division name	Department of Child Neuropsychiatry
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL	03-5800-8664
Email	ayayak-tky@umin.ac.jp

Public contact
Name of contact person	1st name Ayaka Middle name Last name Ishii
Organization	University of Tokyo Hospital
Division name	Department of Child Neuropsyachiatry
Zip code	113-8655
Address	7-3-1
TEL	03-5800-8664
Homepage URL
Email	ayayak-tky@umin.ac.jp

Sponsor
Institute	University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Center for Child Health and Development
Name of secondary funder(s)	Japan Society of Promotion of Science Japan Medical Association

IRB Contact (For public release)
Organization	Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address	Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo Faculty of Medicine Bldg.2 7-3-1 Hongo Bunkyo-ku, Tokyo, 1130033 JAPAN
Tel	03-5841-0818
Email	ethics@m.u-tokyo.ac.jp

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	東京大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 26 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	Open public recruiting
Date of protocol fixation	2019 Year 11 Month 11 Day
Date of IRB	2019 Year 11 Month 11 Day
Anticipated trial start date	2019 Year 11 Month 26 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 26 Day
Last modified on	2020 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043967