UMIN-CTR Clinical Trial

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

Children diagnosed with attention-deficit hyperactivity disorder (ADHD) and their mothers

Classification by specialty

Pediatrics	Psychiatry	Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

University of Tokyo Hospital

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development(AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

National Center for Child Health and Development

Name of secondary funder(s)

Japan Society of Promotion of Science
Japan Medical Association

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学医学部附属病院

Date of disclosure of the study information

2019

Year

11

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2019

Year

11

Month

26

Day

Last modified on

2020

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043967