Impact of a behavioural sleep intervention on symptoms and sleep in children with attention deficit hyperactivity disorder, and parental mental health: randomised controlled trial

OBJECTIVE: To examine whether behavioural strategies designed to improve children\u27s sleep problems could also improve the symptoms, behaviour, daily functioning, and working memory of children with attention deficit hyperactivity disorder (ADHD) and the mental health of their parents. DESIGN: Randomised controlled trial. SETTING: 21 general paediatric practices in Victoria, Australia. PARTICIPANTS: 244 children aged 5-12 years with ADHD attending the practices between 2010 and 2012. INTERVENTION: Sleep hygiene practices and standardised behavioural strategies delivered by trained psychologists or trainee paediatricians during two fortnightly consultations and a follow-up telephone call. Children in the control group received usual clinical care. MAIN OUTCOME MEASURES: At three and six months after randomisation: severity of ADHD symptoms (parent and teacher ADHD rating scale IV-primary outcome), sleep problems (parent reported severity, children\u27s sleep habits questionnaire, actigraphy), behaviour (strengths and difficulties questionnaire), quality of life (pediatric quality of life inventory 4.0), daily functioning (daily parent rating of evening and morning behavior), working memory (working memory test battery for children, six months only), and parent mental health (depression anxiety stress scales). RESULTS: Intervention compared with control families reported a greater decrease in ADHD symptoms at three and six months (adjusted mean difference for change in symptom severity -2.9, 95% confidence interval -5.5 to -0.3, P=0.03, effect size -0.3, and -3.7, -6.1 to -1.2, P=0.004, effect size -0.4, respectively). Compared with control children, intervention children had fewer moderate-severe sleep problems at three months (56% v 30%; adjusted odds ratio 0.30, 95% confidence interval 0.16 to 0.59; P<0.001) and six months (46% v 34%; 0.58, 0.32 to 1.0; P=0.07). At three months this equated to a reduction in absolute risk of 25.7% (95% confidence interval 14.1% to 37.3%) and an estimated number needed to treat of 3.9. At six months the number needed to treat was 7.8. Approximately a half to one third of the beneficial effect of the intervention on ADHD symptoms was mediated through improved sleep, at three and six months, respectively. Intervention families reported greater improvements in all other child and family outcomes except parental mental health. Teachers reported improved behaviour of the children at three and six months. Working memory (backwards digit recall) was higher in the intervention children compared with control children at six months. Daily sleep duration measured by actigraphy tended to be higher in the intervention children at three months (mean difference 10.9 minutes, 95% confidence interval -19.0 to 40.8 minutes, effect size 0.2) and six months (9.9 minutes, -16.3 to 36.1 minutes, effect size 0.3); however, this measure was only completed by a subset of children (n=54 at three months and n=37 at six months). CONCLUSIONS: A brief behavioural sleep intervention modestly improves the severity of ADHD symptoms in a community sample of children with ADHD, most of whom were taking stimulant medications. The intervention also improved the children\u27s sleep, behaviour, quality of life, and functioning, with most benefits sustained to six months post-intervention. The intervention may be suitable for use in primary and secondary care.Trial registration Current Controlled Trials ISRCTN68819261

Preventing mental health problems in children : the families in mind population-based cluster randomised controlled trial.

BackgroundExternalising and internalising problems affect one in seven school-aged children and are the single strongest predictor of mental health problems into early adolescence. As the burden of mental health problems persists globally, childhood prevention of mental health problems is paramount. Prevention can be offered to all children (universal) or to children at risk of developing mental health problems (targeted). The relative effectiveness and costs of a targeted only versus combined universal and targeted approach are unknown. This study aims to the effectiveness, costs and uptake of two approaches to early childhood prevention of mental health problems ie: a Combined universal-targeted approach, versus a Targeted only approach, in comparison to current primary care services (Usual care).DesignThree armed, population-level cluster randomised trial (2010-2014) within the universal, well child Maternal Child Health system, attended by more than 80% of families in Victoria, Australia at infant age eight months. Participants: Families of eight month old children from nine participating local government areas. Randomised to one of three groups: Combined, Targeted or Usual care. Intervention: (a) the Combined universal and targeted program where all families are offered the universal Toddlers Without Tears group parenting program followed by the targeted Family Check-Up one-on-one program or (b) the Targeted Family Check-Up program. The Family Check-Up program is only offered to children at risk of behavioural problems. Analysis: Participants will be analysed according to the trial arm to which they were randomised, using logistic and linear regression models to compare primary and secondary outcomes. An economic evaluation (cost consequences analysis) will compare incremental costs to all incremental outcomes from a societal perspective.DiscussionThis trial will inform public health policy by making recommendations about the effectiveness and cost-effectiveness of these early prevention programs. If effective prevention programs can be implemented at the population level, the growing burden of mental health problems could be curbed.<br /

Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial

Objective To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children

Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project

<p>Abstract</p> <p>Background</p> <p>Up to 70% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) experience sleep problems including difficulties initiating and maintaining sleep. Sleep problems in children with ADHD can result in poorer child functioning, impacting on school attendance, daily functioning and behaviour, as well as parental mental health and work attendance. The Sleeping Sound with ADHD trial aims to investigate the efficacy of a behavioural sleep program in treating sleep problems experienced by children with ADHD. We have demonstrated the feasibility and the acceptability of this treatment program in a pilot study.</p> <p>Methods/Design</p> <p>This randomised controlled trial (RCT) is being conducted with 198 children (aged between 5 to 12 years) with ADHD and moderate to severe sleep problems. Children are recruited from public and private paediatric practices across the state of Victoria, Australia. Upon receiving informed written consent, families are randomised to receive either the behavioural sleep intervention or usual care. The intervention consists of two individual, face-to-face consultations and a follow-up phone call with a trained clinician (trainee consultant paediatrician or psychologist), focusing on the assessment and management of child sleep problems. The primary outcome is parent- and teacher-reported ADHD symptoms (ADHD Rating Scale IV). Secondary outcomes are child sleep (actigraphy and parent report), behaviour, daily functioning, school attendance and working memory, as well as parent mental health and work attendance. We are also assessing the impact of children's psychiatric comorbidity (measured using a structured diagnostic interview) on treatment outcome.</p> <p>Discussion</p> <p>To our knowledge, this is the first RCT of a behavioural intervention aiming to treat sleep problems in children with ADHD. If effective, this program will provide a feasible non-pharmacological and acceptable intervention improving child sleep and ADHD symptoms in this patient group.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN68819261.</p> <p> ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN68819261">ISRCTN68819261</a></p

The impact of COVID-19 on the Early Language in Victoria Study

The Early Language in Victoria Study (ELVS) is an unprecedented longitudinal cohort of young people whose language development and academic progress have been repeatedly measured since infancy (n=1,910 at ~8 months old). ELVS will address critical knowledge gaps about the importance of language, literacy, and numeracy skills for a successful transition to adulthood and life-long well-being, including service costs and health-related quality of life. To document the transition from late adolescence to young adulthood, ELVS participants, who are now completing their formal schooling, and their parents, were approached in late 2020 to consent for follow-up (>17 years). Coinciding with the COVID-19 pandemic, it presented unique challenges for ELVS particularly surrounding recruitment and participation. Responding quickly to challenges posed by the pandemic, the research team modified study processes and developed strategies to promote participant engagement. By conducting recruitment and participation entirely online, data collection was packaged and delivered remotely using multiple brief surveys to minimise fatigue, create flexibility for participation, enhance data quality, and eliminate the need for face-to-face study visits. Despite these efforts, recruitment has been extended and consent rates have been impacted. It is likely that further adaptations are imminent for ELVS ensuring rigour and conformance to good research practice.No Full Tex