Condition category
Mental and Behavioural Disorders
Date applied
04/02/2020
Date assigned
16/03/2020
Last edited
16/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is characterised by higher levels of inattentive, hyperactive and impulsive behaviours. Children with ADHD have difficulty taking turns, are frequently forgetful, talk excessively, often appear not to be listening when spoken to, and tend to interrupt and intrude on others in group activities, conversations and classroom discussions. Parenting a child with ADHD is especially demanding. Parents of children with ADHD report elevated levels of parenting stress and depression, which impacts negatively on their parenting practices. Interactions between parents and children with ADHD have been shown to be more negative and controlling than those of parents of typically developing children. Furthermore, mothers’ experiencing high levels of distress often lack the motivation or organisational skills to parent their child in a consistent way. Addressing the psychological needs of parents’ of children with ADHD would seem, therefore, to be an important treatment target together with strategies to manage the children’s symptoms of ADHD. However, the majority of available programmes focus on teaching behaviour modification/parenting skills to parents.
To date, only a small number of studies have directly targeted the psychological difficulties parents of children with ADHD face. Group-based programmes for parents of children with behaviour problems, including ADHD, have been shown to result in positive changes in mother’s perceptions of their child’s behaviour. However, most group-based treatments report minimal effect on the core symptoms of ADHD as they target the parental management of overt oppositional behaviours rather than the impairments underlying ADHD in the child. The New Forest Parenting Program (NFPP) was developed specifically for children with ADHD, targeting the core symptoms of the disorder including attention, impulse control, and self-organisation. The Parent Stress Management Programme was also specifically developed to target parental well-being of parents of children with ADHD. Well Parent Japan is a modified hybrid programme which contains information and education about ADHD, four sessions from the Parent Stress Management Programme targeting both stress and mood difficulties and a culturally adapted Japanese version of the New Forest Parenting Programme. The Well Parent Japan intervention has been evaluated in a small scale study and has been shown to be helpful at reducing child symptoms and behaviours, enhancing parental well-being and parenting practices immediately after the end of the intervention.
The aim of this study is to extend the results of this small scale trial to a much larger trial run at three different hospitals in Japan, evaluating the Well Parent Japan intervention in routine ADHD clinics and comparing it to treatment as usual (what those clinics usually offer). The study will also aim to evaluate the intervention both immediately after mothers have received it, but also at a three-month follow-up to explore the impact of Well Parent Japan on child behaviour, symptoms, impairment and impact on the family, parental well-being, parenting practice and maternal emotional relationships. There will also be an economic evaluation to establish how much it costs to delivery Well Parent Japan in routine Japanese health care settings, and to also determine how cost-effective the intervention is.

Who can participate?
Japanese mothers of children with a diagnosis of ADHD aged 6-12, whose children are associated with the hospital clinics at the three study sites (Fukui University Hospital, Fukui, Japan Kurume University Hospital, Fukuoka, Japan and Ryukyu University Hospital, Okinawa, Japan

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) take part in 13 two-hour sessions of a group parent training programme for Japanese mothers of children with ADHD aged 6 to 12 (5 sessions of parent stress reduction and 8 sessions of the NFPP). Those in group 2 (treatment as usual) will continue to receive whatever is offered by their hospital clinic. All participants are asked to complete questionnaires at all three timepoints and also take part in observations while helping their child to make pasta and a short interview where they describe their child and how they get along with them at time one and two only. Mothers in the treatment as usual arm of the study will be offered the Well Parent Japan intervention at the end of the study and complete a fourth set of questionnaires after completion of the intervention to increase the number of parents available for the analysis to determine which type of children and mothers respond best to Well Parent Japan.

What are the possible benefits and risks of taking part?
Mothers can gain skills to improve their parenting practices and strategies to help them to help their child. There are no identified risks of participating.

Where is the study run from?
1. Okinawa Institute of Science and Technology Graduate University (Japan)
2. University of Fukui Hospital (Japan)
3. Kurume University Hospital (Japan)
4. National Hospital Organization Ryukyu Hospital (Japan)

When is the study starting and how long is it expected to run for?
August 2018 to March 2022

Who is funding the study?
Okinawa Institute of Science and Technology Graduate University (Japan)

Who is the main contact?
Dr S Shimabukuro
shizuka.shimabukuro@oist.jp

Trial website

Contact information

Type

Public

Primary contact

Dr Shizuka Shimsbukuro

ORCID ID

http://orcid.org/0000-0003-2899-2788

Contact details

Okinawa Institute of Science and Technology Graduate University
Onna-son
904-0495
Japan
+81 (0)98 966 8814
shizuka.shimabukuro@oist.jp

Type

Scientific

Additional contact

Dr Shizuka Shimabukuro

ORCID ID

http://orcid.org/0000-0003-2899-2788

Contact details

Okinawa Institute of Science and Technology Graduate University (Japan)
Onna-son
904-0495
Japan
+81 (0)98 966 8814
shizuka.shimabukuro@oist.jp

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

HSR-2019-014

Study information

Scientific title

A pragmatic randomised controlled cost-effectiveness study of Well Parent Japan for Japanese mothers of children with Attention Deficit Hyperactivity Disorder (ADHD): the TRaining And Nurturing Support FOR Mothers (TRANSFORM) study

Acronym

TRANSFORM

Study hypothesis

1. That Well Parent Japan (WPJ) will be superior to Treatment As Usual (TAU) on measures of child behaviour, parental well-being and parental and objective measure of parenting
2. That Well Parent Japan will be more cost-effective than Treatment As Usual based on ADHD symptom reduction using incremental cost-effectiveness ratios (ICER)
3. That there will be no significant exploratory predictors of Well Parent Japan treatment outcome

Ethics approval

Approved 13/12/2019, Okinawa Institute of Science and Technology Graduate School Human Subject Research Review Committee (Occupational Health and Safety Section, Human Subject Research Review Committee, Lab 1, B051, 1919-1 Tancha, Onna-son, Kunigami-gun Okinawa, Japan 904-0495; Tel: +81 (0)98 966 2385; Email: research_oist.jp), ref: HSR-2019-014

Study design

Two-arm pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format

Condition

Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

Well Parent Japan is a 13-session group-based intervention for parents of children with ADHD. The program includes an orientation to the intervention and psycho-education about ADHD, four sessions devoted to enhancing mothers psychological functioning based on Parent Stress Management for ADHD developed by Tracy Tripp & Baird (2005) followed by the eight sessions of behaviour management based on a Japanese cultural adaption of the core components of the New Forest Parenting Programme (Sonuga-barke et al 2001; Shimabukuro et al 2017; Shimabukuro et al 2020).

Participants are randomly allocated into one of two groups. The method of randomization is at the individual level using a random number generator at the University of Nottingham. Those in group 1 (intervention group) take part in 13 two-hour sessions of a group parent training programme for Japanese mothers of children with ADHD aged 6 to 12 (5 sessions of parent stress reduction and 8 sessions of the NFPP). Those in group 2 (treatment as usual) will continue to receive whatever is offered by their hospital clinic. All participants are asked to complete questionnaires at all three timepoints and also take part in observations while helping their child to make pasta and a short interview where they describe their child and how they get along with them at time one and two only. Mothers in the treatment as usual arm of the study will be offered the Well Parent Japan intervention at the end of the study and complete a fourth set of questionnaires after completion of the intervention to increase the number of parents available for the analysis to determine which type of children and mothers respond best to Well Parent Japan. The total duration of follow up is 13 weeks post-intervention 26 weeks after the start of the intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Parent stress measured by the Parent Stress Index (PSI) at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis

T1: baseline, T2: 14 weeks, T3: 26 weeks, T4: 39 weeks, T5: 51 weeks

Secondary outcome measures

1. Parenting style measured by the Parenting Scale at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis
2. Parenting competence/efficacy measured by the Parenting Sense of Competence Scale (PSOC) at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis
3. Locus of control assessed using the Parental Locus of Control Scale (PLOC) at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis
4. Mother’s mood measured by BDI-2 at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis
5. Child’s ADHD symptoms measured by mother and teacher by the Swanson, Nolan & Pelham Scale SNAP at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis
6. Parent/caregiver and teacher perceptions of emotional and behavioural problems in children measured by the Child Behavior Check List (CBCL) and Teacher Rating Form (TRF) at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis
7. Child’s impairment in school performance and relationship measured by mother and teacher by the performance scale from the Vanderbilt Assessment Scale at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis
8. Child’s impairment in eight different domains of functioning measured by the Impairment Rating Scale at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis
9. Family stress, strain and burden measured by the Family Strain Index (FSI) T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis
10. Mother-child interaction assessed by direct observation of behavior during a co-operative pasta-making task. Mother and child will be video-recorded and coded by an independent coder. Interactions will be coded using codes from the System for Coding Interactions and Family Functioning (SCIFF) and the System for Coding Interactions in Parent-Child Dyads (SCIPD) at T1 and T2
11. Mother’s expressed emotion measured by using the Revised Five-minute Speech Sample (R-FMSS) at T1 and T2
12. Cost-effectiveness of this study measured by the modified Client Service Receipt Inventory (CSRI) at T1 T2 and T3
13. Autism Spectrum Disorder (ASD) measured using the Autism Spectrum Quotient at baseline only at T1
4. Mother’s ADHD measured by the Conners Adult ADHD Rating Scale (CAARS) at baseline only at T1

T1: baseline, T2: 14 weeks, T3: 26 weeks, T4: 39 weeks, T5: 51 weeks

Overall trial start date

30/08/2018

Overall trial end date

31/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Mothers of children diagnosed with ADHD and the children themselves will be identified by health professionals working in hospitals or community clinics linked to the three research sites in Japan. Inclusion criteria for mothers will be:
1. Fluency in Japanese (reading and writing)
2. Parenting a child, 6-12 years who is diagnosed with ADHD
3. Participation in a behavioural intervention for the mother is not contra-indicated as viewed by the referring clinician

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Children with very little pragmatic speech as judged by the referring clinician
2. Children with functional intellectual disability
3. Mothers who are currently or have recently taken part in other parenting intervention (within two months)

Recruitment start date

13/08/2019

Recruitment end date

30/09/2021

Locations

Countries of recruitment

Japan

Trial participating centre

University of Fukui Hospital
23-3 Matsuokashimoaizuki Eiheiji Yoshida District
Fukui
910-1193
Japan

Trial participating centre

Kurume University Hospital
67 Asahimachi Kurume
Fukuoka
830-0011
Japan

Trial participating centre

National Hospital Organization Ryukyu Hospital
Kin 7958-1 Aza Kin-cho, Kunigami-gun
Okinawa
904-1201
Japan

Sponsor information

Organisation

Okinawa Institute of Science and Technology Graduate University

Sponsor details

1919-1 Tancha Onna-son
Kunigami-gun
Okinawa
904-0495
Japan
+81 (0)98 966 1512
grants@oist.jp

Sponsor type

University/education

Website

http://www.oist.jp/

Funders

Funder type

University/education

Funder name

Okinawa Institute of Science and Technology Graduate University

Alternative name(s)

Okinawa Institute of Science and Technology, OIST

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Japan

Results and Publications

Publication and dissemination plan

Study protocol manuscript to be submitted. The intention is to publish one main trial outcome paper which will contain both the immediate and longer term effectiveness and cost effectiveness data and a second paper which will report the exploratory predictors of outcome.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made publicly available but individual requests for access to the data will be considered subject to Japanese law.

Intention to publish date

01/04/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/02/2020: Trial's existence confirmed by Okinawa Institute of Science and Technology Graduate School Human Subject Research Review Committee.