Condition category
Mental and Behavioural Disorders
Date applied
22/10/2014
Date assigned
17/11/2014
Last edited
30/08/2016
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 behavioural disorder, the symptoms of which include not paying attention, hyperactivity and impulsive behaviour. Symptoms occur at an early age but often improve at the patient grows older. Children with ADHD can also suffer from sleep problems, where the child either has difficulty getting to sleep or frequently wakes up during the night. This symptom, however, is often overlooked. Up to 70% of children with ADHD experience sleep problems, compared with 20-30% of children in the general population. In 2010 we ran a two year study to test a new behavioural sleep programme (intervention) for children with ADHD and sleeping problems (ISRCTN68819261). The study took place from 21 paediatric practices across Victoria, Australia and the programme found to have a beneficial effect. A lack of sleep can have an effect on a person’s memory and make them more forgetful. Six months into the trial, we tested the effect of children’s memory using the Working Memory Test Battery for Children and found that their memory had improved. Here, we want to investigate the feasibility and cost-effectiveness of delivering this behavioural sleep intervention at the population level through paediatricians and child psychologists in Victoria and Queensland, Australia.

Who can participate?
Children aged 5-12 years with paediatrician diagnosed ADHD from paediatric practices in Victoria and Queensland.

What does the study involve?
Participating paediatricians are randomised to either a intervention or control group and all their participating patients will be allocated to that group with them. Those paediatricians randomised to the control group do have further contact with the research team. Those paediatricians randomised to the intervention group are trained by the research team in how to treat children using a brief behavioural sleep intervention. If paediatricians have a large number of patients enrolled in the study the participants are randomised to receive treatment either by their paediatrician or by a psychologist (who will also be trained to how treat children using the intervention). After training the health professionals deliver the 2 session intervention to participating families. Families of children attending a paediatrician randomised to the control group receive ‘usual care’ which involves seeing their paediatrician as per usual regarding their child’s ADHD. Paediatricians typically see children with ADHD every 6 months to check their height, weight, blood pressure and re-issue a script for medication (valid for 6 months), where necessary. Families will be followed up at 3 and 6 months post intervention to see how the intervention is helping.

What are the possible benefits and risks of participating?
It is assumed that the strategies and information provided to parents in the intervention group will help manage their child’s sleep problems. There are no direct benefits of participation for those in the control group. We do not anticipate any risks or side-effects associated with participation in this study. Participants assigned to the intervention group may be inconvenienced by the need to attend 2 x 45-60 minute sessions with their paediatrician or psychologist.

Where is the study run from?
The study is being led by the Murdoch Children’s Research Institute in Victoria and has a second site located in Queensland at the Mater Research Institute and University of Queensland. Deakin University are providing support with the health economics evaluation.

When is study starting and how long is it expected to run for?
November 2014 to December 2018

Who is funding the study?
Australian National Health and Medical Research Centre Project Grant 1058827 (Australia)

Who is the main contact?
Professor Harriet Hiscock
harriet.hiscock@rch.org.au

Trial website

http://www.rch.org.au/ccch/for_researchers/Sleeping_Sound_with_ADHD/#Sleeping_Sound_2

Contact information

Type

Scientific

Primary contact

Prof Harriet Hiscock

ORCID ID

Contact details

Centre for Community Child Health
The Royal Children's Hospital
Flemington Road
Parkville
3052
Australia
+61 3 9936 6628
harriet.hiscock@rch.org.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1058827

Study information

Scientific title

Does a brief, behavioural sleep intervention, delivered by trained paediatricians and psychologists improve sleep, ADHD symptom severity and behaviour for children with ADHD? A cluster-randomised, translational trial

Acronym

SSADHD

Study hypothesis

Hypotheses as of 30/08/2016:
Compared to control children receiving standard care:
1. At 3 and 6 months post-randomisation, a brief, behavioural sleep intervention delivered by paediatricians/clinical psychologists will:
1.1. Decrease prevalence (primary outcome) and severity (secondary outcome) of child sleep problems
1.2. Improve child ADHD symptoms as rated by primary caregivers and teachers
1.3. Improve functioning in other child (ADHD symptoms, QoL, behaviour, working memory, executive functioning, learning, academic achievement, school attendance) and primary caregiver (mental health, parenting, work attendance) outcome domains
2. The intervention will be cost effective. We will first present a cost-consequences analysis, then proceed to cost-effectiveness analysis against the primary outcome measure as primary economic analysis. Secondary economic analysis will include cost-utility analysis against CHU9D-based Quality of Life Years.

Original hypotheses:
Compared to control children receiving standard care:
1. At 3 and 6 months post-randomisation, a brief, behavioural sleep intervention delivered by paediatricians/clinical psychologists will:
1.1. Decrease prevalence (primary outcome) and severity (secondary outcome) of child sleep problems;
1.2. Improve child ADHD symptoms as rated by primary caregivers and teachers; and
1.3. Improve functioning in child (quality of life, behaviour, working memory, and academic achievement) and primary caregiver (mental health) outcome domains.
2. The intervention will be cost effective. We will first present a cost-consequences analysis, then proceed to cost-effectiveness analysis against the primary outcome measure as primary economic analysis. Secondary economic analysis will include cost-utility analysis against CHU9D-based Quality of Life Years.

Ethics approval

The Royal Children’s Hospital Human Research Ethics Committee, 13/06/2014; ref: 34072

Study design

Multi-site cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Attention deficit hyperactivity disorder (ADHD)

Intervention

1. Behavioural sleep intervention (intervention group):
Families in the intervention group will be offered two face-to-face, fortnightly sleep consultations with their paediatrician (or psychologist), with the option for a further follow up phone call. At the first consultation, the clinician will assess the child’s sleep problem, elicit parent goals for sleep management, provide information about normal sleep, sleep cycles, and sleep hygiene strategies, and formulate a behavioural sleep management plan tailored to the child’s sleep problem. Parents will be asked to complete a sleep diary between the first and second consultation. The second consultation and follow-up phone call will be used to review the sleep diary, reinforce suggested strategies and troubleshoot any problems encountered.

2. Usual care (control group):
Families in the usual care group will be able to access usual care for ADHD from their child’s paediatrician and/or other health services.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Parent report of child sleep problem at 3 month follow up

Secondary outcome measures

Child secondary outcome measures include:
1. Sleep: Parent report of child sleep patterns as measured by the Child Sleep Habits Questionnaire at 3 months; sleep problem and patterns at 6 month follow up, teacher report of daytime sleepiness at 3 & 6 month follow up
2. ADHD symptoms (parent and teacher report), measured at 3 & 6 months follow up
2. Psychosocial quality of life (parent report), measured at 6 month follow up
3. Behaviour (parent and teacher report), measured at 3 & 6 months follow up
4. Working memory (blinded, direct assessment), measured at 6 month follow up
5. Academic functioning (blinded, direct assessment), measured at 6 month follow up

Added 30/08/2016:
6. Executive functioning and learning (blinded, direct assessment), measured at 6 month follow up

Parent secondary outcome measures include:
1. Parent mental health, measured at 6 month follow up
2. Parenting behaviours, measured at 6 month follow up

Overall trial start date

01/11/2014

Overall trial end date

01/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Families of children aged 5 - 12 years (either sex) with caregiver report of:
1. Moderate to severe sleep problems
2. ADHD symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for ADHD (child also needs to have been previously diagnosed with ADHD by a paediatrician)
3. At least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2005):
3.1. Sleep onset association disorder
3.2. Limit setting disorder
3.3. Delayed sleep phase
3.4. Primary insomnia
3.5 Anxiety-associated insomnia

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

target number of participants to recruit into the study is 320 (160 randomised to intervention; 160 randomised to control).

Participant exclusion criteria

Potential participants will be excluded from the study if they meet any of the following conditions:
1. Suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with CI Hiscock (paediatrician)
2. Have a major illness (e.g. cerebral palsy) or disability (e.g. intellectual disability)
3. Non-English speaking

Recruitment start date

01/11/2014

Recruitment end date

01/12/2018

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Community Child Health
Parkville
3052
Australia

Sponsor information

Organisation

Murdoch Children's Research Institute (Australia)

Sponsor details

The Royal Children's Hospital
Flemington Road
Parkville
3052
Australia
+61 3 8341 6200
mcri@mcri.edu.au

Sponsor type

Research organisation

Website

http://www.mcri.edu.au

Funders

Funder type

Research organisation

Funder name

Australian National Health and Medical Research Centre (Australia) - Project Grant 1058827

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication in a peer reviewed medical journal
2. Presentation at international conferences

Intention to publish date

30/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/08/2016: The hypothesis and secondary outcome measures have been updated. 01/07/2016: The target number of participants has been corrected from 214 to 320 (214 participants are the number required at follow up, accounting for clustering and dropout.) 08/04/2016: The availability of the participant level data and publication and dissemination plan added. 05/04/2016: The target number of participants has been updated from 476 to 214.