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
http://orcid.org/0000-0003-2899-2788
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, 01/08/2014. , 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
This is small-scale randomised controlled trial to assess the efficacy of New Forest Parenting Program-Japan (NFPP-J) when compared to a wait list control group. The trial will have one treatment arm: a group receiving NFPP-J and a wait list control group who will be offered NFPP-J at the end of the trial.
Arm 1: Mothers are invited to take part in a thirteen-session group parenting program that incorporates 5 sessions of psycho-education (knowledge of ADHD, stress management and relaxation, cognitive restructuring, problem solving skills, effective communication skills) and 8 sessions of New Forest Parenting Program (NFPP).
Arm 2: Wait-list control mothers accepting offer of treatment complete program as described for Arm 1.
When sufficient participants meeting inclusion criteria are recruited they will be randomised to a study arm using a simple randomisation procedure based on a computer random number generator. Time 1 outcome measures will be obtained from parents and teachers, including the FMSS and the parent-child interaction task prior to randomisation to study arm.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Parental self report on the parenting stress index short form at baseline and 14 weeks.
Secondary outcome measures
1. Self reported parenting practices on the parenting scale and objective parenting measured via structured observations of parent-child interaction at baseline and 14 weeks
2. Parent and teacher reports of ADHD symptoms on the Swanson Nolan and Pelham scale (SNAP) at baseline and 14 weeks
3. Internalising and externalising problems as measured by parental report on the Child Behavior Checklist (CBCL) at baseline and 14 weeks
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.
IPD Sharing plan:
Data will not be shared because neither the ethics application nor consent forms included the statement that the raw data and/or anonymized data will be made available. Data from this randomized control trial is not expected to be made available.
Intention to publish date
01/03/2017
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary