Condition category
Mental and Behavioural Disorders
Date applied
29/05/2015
Date assigned
15/06/2015
Last edited
05/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by elevated 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 aim of this study is to see how well a modified parenting programme incorporating the NFPP works to reduce mothers’ stress and help them to manage their child’s ADHD behaviour.

Who can participate?
Japanese mothers of children with symptoms of ADHD aged 6-12.

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 (control group) are put on a waitlist and are given access to the same group parent training programme as the intervention group once the other group have completed the sessions. All participants are asked to complete questionnaires.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Okinawa Institute of Science and Technology Graduate University (Japan)

When is the study starting and how long is it expected to run for?
September 2014 to July 2017

Who is funding the study?
1. Okinawa Institute of Science and Technology Graduate University (Japan)
2. Japan Society for the Promotion of Science (KAKENHI) (Japan)

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shizuka Shimabukuro

ORCID ID

Contact details

Okinawa Institute of Science and Technology Graduate University Human Developmental Neurobiology Unit 7542 Onna
Onna
904-0411
Japan
81-98-966-8802
shizuka.shimabukuro@oist.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HSR-2014-005

Study information

Scientific title

Randomised controlled trial of a modified version of the New Forest Parenting Programme for Japanese mothers of children at risk of attention deficit hyperactivity disorder (ADHD)

Acronym

Study hypothesis

1. The intervention will be associated with a great reduction in parenting stress relative to the wait-list control group
2. The intervention will be associated with greater enhancement of parenting skills relative to the wait-list control group
3. The intervention group will display greater reduction of behaviour problems (ADHD and conduct problems) relative to the wait-list control group

Ethics approval

Okinawa Institute of Science and Technology Graduate University Institutional Review Board, ref: HSR-2014-005

Study design

Two-arm randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Attention deficit hyperactivity disorder (ADHD)

Intervention

1. The intervention group has 13 two-hour sessions of a group training programme, consisting of five sessions of parent stress management (modifed from the core principles outlined by Tracy and Tripp) and eight culturally modified sessions of the New Forest Parenting Programme
2. The waitlist-control group has no active stress reduction or behaviour parent training support until the end of the trial when parents are given the same parenting package given to the intervention group.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Parental self report on the parenting stress index short form.

Secondary outcome measures

1. Self reported parenting practices on the parenting scale and objective parenting measured via structured observations of parent-child interaction
2. Parent and teacher reports of ADHD symptoms on the Swanson Nolan and Pelham scale (SNAP)
3. Internalising and externalising problems as measured by parental report on the Child Behavior Checklist (CBCL)

Overall trial start date

20/09/2014

Overall trial end date

30/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Children at risk of ADHD aged 6-12 and their mothers. Children at risk of ADHD are identified through a three stage process:
1. Parental concern about child's ADHD behaviours
2. Child's score above the point of clinical concern on the parent SNAP
3. Parent willing to engage in behavioral intervention

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

60 parent-child dyads

Participant exclusion criteria

1. Primary diagnosis of ASD
2. Families where the father is the primary caregiver
3. Japanese is not first language
4. Severe maternal mental illness

Recruitment start date

01/07/2014

Recruitment end date

30/01/2017

Locations

Countries of recruitment

Japan

Trial participating centre

Okinawa Institute of Science and Technology Graduate University
7542 Onna
Onna-son Okinawa
904-0411
Japan

Sponsor information

Organisation

Okinawa Institute of Science and Technology Graduate Univers

Sponsor details

7542 Onna
Onna-son Okinawa
904-0411
Japan
81-98-966-8802
shizuka.shimabukuro@oist.jp

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Okinawa Institute of Science and Technology Graduate University (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Japan Society for the Promotion of Science (KAKENHI) (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Irrespective of the trial outcome the results of the trial will be submitted for publication in an international peer reviewed journal.

Intention to publish date

01/03/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/09/2016: The recruitment end date has been updated from 01/03/2016 to 30/01/2016 and the overall trial end date has been updated from 01/07/2016 to 30/07/2017