The relative efficacy of two brief treatments for sleep problems in young learning disabled (mentally retarded) children: a randomised controlled trial

Abstract

Background: Settling and night waking problems are particularly prevalent, persistent, and generally considered difficult to treat in children with a learning disability, although intervention trials are few. Scarce resources, however, limit access to proven behavioural treatments. Aims: To investigate the efficacy of a media based brief behavioural treatment of sleep problems in such children by comparing (1) face-to-face delivered treatment versus control and (2) booklet delivered treatment versus controls. Methods: The parents of 66 severely learning disabled children aged 2-8 years with settling and/or night waking problems took part in a randomised controlled trial with a wait-list control group. Behavioural treatments were presented either conventionally face-to-face or by means of a 14 page easy to read illustrated booklet. A composite sleep disturbance score was derived from sleep diaries kept by parents. Results: Both forms of treatment were almost equally effective compared with controls. Two thirds of children who were taking over 30 minutes to settle five or more times per week and waking at night for over 30 minutes four or more times per week improved on average to having such settling or night waking problems for only a few minutes or only once or twice per week (H = 34.174, df = 2, p,0.001). These improvements were maintained after six months. Conclusions: Booklet delivered behavioural treatments for sleep problems were as effective as face-to-face treatment for most children in this population.

The use of MElatonin in children with Neurodevelopmental Disorders and impaired Sleep: a randomised, double-blind, placebo-controlled, parallel study (MENDS).

“…However, it is questionable whether or not a 1-point reduction on a 12-point scale is clinically important; previous work has suggested that at least a 50% reduction in problems is considered by parents to be worthwhile. 45 The unadjusted results of the other instruments tended to favour melatonin but improvements were small. On average, a reduction of 4 points on the 100-point scale was estimated for each domain in the PedsQL Family Impact Module.…”

“…Removed GOSH and Northampton from lists of pharmacies and centres as these centres were never initiated. 7, 37, 39, 45 References to Epworth Sleepiness Scale put back into their original locations in the protocol. In the previous substantial amendment, the removal of the Epworth Sleepiness Scale was described in the substantial amendment form in error.…”

“…al. (45) will be used to impute genotype data for the SNPs not included on the chip. These imputed genotypes will be tested for association in exactly the same way as the SNPs actually genotyped.…”

“…If one of the removed TESS is reported spontaneously by a child or their care-giver they will still be reported as expected (based on their presence in the investigator's brochure and reviewed for relationship to study drug, severity and seriousness. [44][45] Removal of obsolete text and instructions relating to the completion of the neuropsychological electronic tests. 48 Removal of obsolete secondary outcomes: attention and vigilance assessed in care-givers using the car game from the DENEM project and attention and vigilance assessed in children using the Go/No go game from the MARS battery.…”

Replacing home visits with telephone calls to support parents implementing a sleep management intervention: findings from a pilot study and implications for future research

“…These involve a detailed assessment, the creation of an individualised behavioural sleep management strategy and time-limited, (typically) face-to-face support as parents implement the strategy. However, despite promising evidence regarding their effectiveness (Vriend et al 2011, McDaid andSloper 2009) these interventions are not routinely available (Montgomery et al 2004).…”