Dominic Trépel

The prevalence of obesity appears greater in people with intellectual disabilities than those in the general population. This study aimed to examine the nutritional intake and anthropometric status of individuals with intellectual disabilities. Participants aged 16–64 years were recruited from intellectual disability service provider organizations (n ¼ 131). Data were collected using questionnaires ; 4-day food dairies and weight, height and waist circumference measurements. Parti-cipants' mean body mass index (BMI) was 29.4 kg/m 2 + 6.1, 2.4% were underweight, 22.6% were normal weight, 28.2% were overweight and 46.8% were obese. Having a diagnosis of Down syndrome (p ¼ 0.03) was associated with increasing BMI. Increasing waist circumference was associated

Services have variable practices for identifying and providing interventions for 'severe attachment problems' (disorganised attachment patterns and attachment disorders). Several government reports have highlighted the need for better parenting interventions in at-risk groups. This report was commissioned to evaluate the clinical effectiveness and cost-effectiveness of parenting interventions for children with severe attachment problems (the main review). One supplementary review explored the evaluation of assessment tools and a second reviewed 10-year outcome data to better inform health economic aspects of the main review. A total of 29 electronic databases were searched with additional mechanisms for identifying a wide pool of references using the Cochrane methodology. Examples of databases searched include PsycINFO (1806 to January week 1, 2012), MEDLINE and MEDLINE In-Process & Other Non-Indexed Citations (1946 to December week 4, 2011) and EMBASE (1974 to week 1, 2012)...

Objective: To systematically review the accuracy of the GAD-7 and GAD-2 questionnaires for identifying anxiety disorders. Methods: A systematic review of the literature was conducted to identify studies that validated the GAD-7 or GAD-2 against a recognized gold standard diagnosis. Pooled estimates of diagnostic test accuracy were produced using random-effects bivariate metaanalysis. Heterogeneity was explored using the I 2 statistic. Results: A total of 12 samples were identified involving 5223 participants; 11 samples provided data on the accuracy of the GAD-7 for identifying generalized anxiety disorder (GAD). Pooled sensitivity and specificity values appeared acceptable at a cutoff point of 8 [sensitivity: 0.83 (95% CI 0.71–0.91), specificity: 0.84 (95% CI 0.70–0.92)] although cutoff scores 7–10 also had similar pooled estimates of sensitivity/specificity. Six samples provided data on the accuracy of the GAD-2 for identifying GAD. Pooled sensitivity and specificity values appeared acceptable at a cutoff of 3 [sensitivity: 0.76 (95% CI 0.55–0.89), specificity: 0.81 (95% CI 0.60–0.92)]. Four studies looked at the accuracy of the questionnaires for identifying any anxiety disorder. Conclusions: The GAD-7 had acceptable properties for identifying GAD at cutoff scores 7–10. The GAD-2 had acceptable properties for identifying GAD at a cutoff score of 3. Further validation studies are needed.

Background: Using patient-reported outcome measures (PROMs) to assess Quality of Life (QoL) is well established, but commonly-used PROM item-sets do not necessarily capture what all respondents consider important. Measuring complex constructs is particularly difficult in randomised controlled trials (RCTs). The Mother-Generated Index (MGI) is a validated antenatal and postnatal QoL instrument in which the variables and scores are completely respondent-driven. This paper reports on the feasibility and acceptability of the MGI in an RCT, and compares the resulting variables and QoL scores with more commonly used instruments. Methods: The single-page MGI was included at the end of a ten page questionnaire pack and posted to the RCT participants at baseline (28–32 weeks' gestation) and follow-up (six weeks postnatal). Feasibility and acceptability were assessed by ease of administration, data entry and completion rates. Variables cited by women were analysed thematically. MGI QoL scores were compared with outcomes from the EQ-5D-3 L; Edinburgh Postnatal Depression Scale; Satisfaction With Life Scale; and State Trait Anxiety Inventory.

Previous research has highlighted that while involvement in Special Olympics can have benefits for athletes and their families, there can also be many barriers to participation. This qualitative study, which was part of a large mixed-method study, examined the experiences and perspectives of people with intellectual disability, their families and staff who work with them, about Special Olympics Ireland (SOI). A total of 47 participants (15 athletes, 6 non-athletes, 18 family members and 8 staff members) participated in focus group and individual interviews. Supplemental data, gathered as part of the larger study extracted from open-ended survey questions completed by 97 family members also informed this element. Findings revealed four main themes: impact of participation on athletes, impact of involvement on families, barriers to participation and how to enhance participation rates. Involvement in Special Olympics impacted positively on the quality of life of athletes and families. Enhanced availability of user-friendly information and service accessibility were important drivers identified for enhancing participation rates in Special Olympics.

Background
A Social Story™ (Carol Gray) is a child-friendly intervention that is used to give children with autism spectrum disorders (ASDs) social information in situations where they have social difficulties. Limited evidence mainly using single-case designs suggests that they can reduce anxiety and challenging behaviour.
Objectives
The objectives were to conduct a systematic review, use this to develop a manualised intervention and run a feasibility trial to inform a fully powered randomised controlled trial (RCT) on their clinical effectiveness and cost-effectiveness in schools.
Design
This is a three-stage study following the Medical Research Council framework for complex interventions. Specifically, it involved a theoretical phase, a qualitative stage and a feasibility trial stage.
Setting
Qualitative interviews and focus groups took place in Child and Adolescent Mental Health Service and primary care settings. The feasibility study took place in 37 local mainstream schools.
Participants
Fifty children (aged 5–15 years) in mainstream school settings with a diagnosis of ASD were entered into the trial. For each child, an associated teacher and parent was also recruited.
Interventions
The intervention was a goal-setting session followed by a manualised toolkit (including a training session) for creating Social Stories™ for use with school-aged children. The comparator treatment was a goal-setting session followed by an attention control. Both arms received treatment as usual.
Main outcome measures
Outcomes tested as part of the feasibility study included child- and proxy-completed questionnaires for mental health, quality of life and goal-based outcome measures. Adults additionally completed behaviour diaries and the parental stress index.
Results
The review found that the research into social stories is predominantly based in the USA, carried out in under-12-year-olds and using single-case designs. Most studies either did not follow established Social Story criteria or did not report if they did. The assessment of effectiveness presents a largely positive picture but is limited by methodological issues. There were no adequate RCTs and insufficient information to assess a number of important sources of potential bias in most studies. A manualised intervention was produced using an iterative process between user focus groups and a writing team, and assessed in the feasibility study. All 50 participant groups were recruited within the study time frame. Two outcome measures, the Social Responsiveness Scale-2 and the custom-made goal-based measure, showed high levels of completion rates and appeared to be capturing social and behaviour skills targeted by the use of Social Stories. Detailed recommendations for a full trial are provided.
Limitations
Blinding of participants was not feasible. Treatment fidelity was not assessed because of low levels of story return rates.
Conclusions
The study showed that a fully powered RCT is feasible with an extended geographical footprint. A large amount of data and information has helped to inform the design of this RCT, which will be the subject of a future research grant application. Future work could focus on developing an appropriate blinded outcome measure for this population.
Study registration
This study is registered as PROSPERO CRD42011001440.
Trial registration
Current Controlled Trials ISRCTN96286707.
Funding
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.

The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT). Adolescents aged 12-18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approa...

Background and objectives: Services have variable practices for identifying and providing interventions
for ‘severe attachment problems’ (disorganised attachment patterns and attachment disorders). Several
government reports have highlighted the need for better parenting interventions in at-risk groups. This
report was commissioned to evaluate the clinical effectiveness and cost-effectiveness of parenting
interventions for children with severe attachment problems (the main review). One supplementary review
explored the evaluation of assessment tools and a second reviewed 10-year outcome data to better inform
health economic aspects of the main review.
Data sources: A total of 29 electronic databases were searched with additional mechanisms for
identifying a wide pool of references using the Cochrane methodology. Examples of databases searched
include PsycINFO (1806 to January week 1, 2012), MEDLINE and MEDLINE In-Process & Other Non-Indexed
Citations (1946 to December week 4, 2011) and EMBASE (1974 to week 1, 2012). Searches were carried
out between 6 and 12 January 2012.
Review methods: Papers identified were screened and data were extracted by two independent
reviewers, with disagreements arbitrated by a third independent reviewer. Quality assessment tools were
used, including quality assessment of diagnostic accuracy studies – version 2 and the Cochrane risk of bias
tool. Meta-analysis of randomised controlled trials (RCTs) of parenting interventions was undertaken.
A health economics analysis was conducted.
Results: The initial search returned 10,167 citations. This yielded 29 RCTs in the main review of parenting
interventions to improve attachment patterns, and one involving children with reactive attachment
disorder. A meta-analysis of eight studies seeking to improve outcome in at-risk populations showed
statistically significant improvement in disorganised attachment. The interventions saw less disorganised
attachment at outcome than the control (odds ratio 0.47, 95% confidence interval 0.34 to 0.65;
p < 0.00001). Much of this focused around interventions improving maternal sensitivity, with or without
video feedback. In our first supplementary review, 35 papers evaluated an attachment assessment tool
demonstrating validity or psychometric data. Only five reported test–retest data. Twenty-six studies
reported inter-rater reliability, with 24 reporting a level of 0.7 or above. Cronbach’s alphas were reported
in 12 studies for the comparative tests (11 with α > 0.7) and four studies for the reference tests (four with
α > 0.7). Three carried out concurrent validity comparing the Strange Situation Procedure (SSP) with
another assessment tool. These had good sensitivity but poor specificity. The Disturbances of Attachment
Interview had good sensitivity and specificity with the research diagnostic criteria (RDC) for attachment
disorders. In our supplementary review of 10-year outcomes in cohorts using a baseline reference
standard, two studies were found with disorganised attachment at baseline, with one finding raised
psychopathology in adolescence. Budget impact analysis of costs was estimated because a decision model
could not be justifiably populated. This, alongside other findings, informed research priorities.
Limitations: There are relatively few UK-based clinical trials. A 10-year follow-up, while necessary for our
health economists for long-term sequelae, yielded a limited number of papers.
Conclusions: Maternal sensitivity interventions show good outcomes in at-risk populations, but require
further research with complex children. The SSP and RDC for attachment disorders remain the reference
standards for identification until more concurrent and predictive validity research is conducted. A birth
cohort with sequential attachment measures and outcomes across different domains is recommended with
further, methodologically sound randomised controlled intervention trials. The main area identified for
future work was a need for good-quality RCTs in at-risk groups such as those entering foster care
or adoption.
Study registration: This study is registered as PROSPERO CRD42011001395.
Funding: The National Institute for Health Research Health Technology Assessment programme.
ABSTRACT
NIHR Journals Library www.journalslibrary.nihr.ac.uk
viii

Introduction Current evidence suggests that Social Stories can be effective in tackling problem behaviours exhibited by children with autism spectrum disorder. Exploring the meaning of behaviour from a child's perspective allows stories to provide social information that is tailored to their needs. Case reports in children with autism have suggested that these stories can lead to a number of benefits including improvements in social interactions and choice making in educational settings.

Methods and analysis The feasibility of clinical and cost-effectiveness of a Social Stories toolkit will be assessed using a randomised control framework. Participants (n=50) will be randomised to either the Social Stories intervention or a comparator group where they will be read standard stories for an equivalent amount of time. Statistics will be calculated for recruitment rates, follow-up rates and attrition. Economic analysis will determine appropriate measures of generic health and resource use categories for cost-effectiveness analysis. Qualitative analysis will ascertain information on perceptions about the feasibility and acceptability of the intervention.

Ethics and dissemination National Health Service Ethics Approval (NHS; ref 11/YH/0340) for the trial protocol has been obtained along with NHS Research and Development permission from Leeds and York Partnership NHS Foundation Trust. All adverse events will be closely monitored, documented and reported to the study Data Monitoring Ethics Committee. At least one article in a peer reviewed journal will be published and research findings presented at relevant conferences.

Trial registration number ISRCTN96286707.

Introduction: The 1 year prevalence of depression in
adolescents is about 2%. Treatment with antidepressant
medication is not recommended for initial treatment in
young people due to concerns over high side effects,
poor efficacy and addictive potential. Evidence suggests
that cognitive behaviour therapy (CBT) is an effective
treatment for depression and is currently one of the
main treatment options recommended in adolescents.
Given the affinity young people have with information
technology they may be treated effectively, more widely
and earlier in their illness evolution using computeradministered
CBT (CCBT). Currently little is known
about the clinical and resource implications of
implementing CCBT within the National Health Service
for adolescents with low mood/depression. We aim to
establish the feasibility of running a fully powered
randomised controlled trial (RCT).
Methods and analysis: Adolescents aged 12–18 with
low mood/depression, (scoring ≥20 on the Mood and
Feelings Questionnaire (MFQ)), will be approached to
participate. Consenting participants will be randomised
to either a CCBT programme (Stressbusters) or
accessing selected websites providing information
about low mood/depression. The primary outcome
measure will be the Beck Depression Inventory (BDI).
Participants will also complete generic health measures
(EQ5D-Y, HUI2) and resource use questionnaires to
examine the feasibility of cost-effectiveness analysis.
Questionnaires will be completed at baseline, 4 and 12-
month follow-ups. Progress and risk will be monitored
via the MFQ administered at each treatment session.
The acceptability of a CCBT programme to adolescents;
and the willingness of clinicians to recruit participants
and of participants to be randomised, recruitment rates,
attrition rates and questionnaire completion rates will be
collected for feasibility analysis. We will estimate
‘numbers needed’ to plan a fully powered RCT of clinical
and cost-effectiveness.
Ethics and dissemination: The current trial protocol
received a favourable ethical opinion from Leeds
(West) Research and Ethics Committee. (Reference:
10/H1307/137).
Trial registration number: ISRCTN31219579.

Abstract
OBJECTIVE:
(Primary) To establish the effect of antenatal group self-hypnosis for nulliparous women on intra-partum epidural use.
DESIGN:
Multi-method randomised control trial (RCT).
SETTING:
Three NHS Trusts.
POPULATION:
Nulliparous women not planning elective caesarean, without medication for hypertension and without psychological illness.
METHODS:
Randomisation at 28-32 weeks' gestation to usual care, or to usual care plus brief self-hypnosis training (two × 90-minute groups at around 32 and 35 weeks' gestation; daily audio self-hypnosis CD). Follow up at 2 and 6 weeks postnatal.
MAIN OUTCOME MEASURES:
Primary: epidural analgesia. Secondary: associated clinical and psychological outcomes; cost analysis.
RESULTS:
Six hundred and eighty women were randomised. There was no statistically significant difference in epidural use: 27.9% (intervention), 30.3% (control), odds ratio (OR) 0.89 [95% confidence interval (CI): 0.64-1.24], or in 27 of 29 pre-specified secondary clinical and psychological outcomes. Women in the intervention group had lower actual than anticipated levels of fear and anxiety between baseline and 2 weeks post natal (anxiety: OR -0.72, 95% CI -1.16 to -0.28, P = 0.001); fear (OR -0.62, 95% CI -1.08 to -0.16, P = 0.009). Postnatal response rates were 67% overall at 2 weeks. The additional cost in the intervention arm per woman was £4.83 (CI -£257.93 to £267.59).
CONCLUSIONS:
Allocation to two-third-trimester group self-hypnosis training sessions did not significantly reduce intra-partum epidural analgesia use or a range of other clinical and psychological variables. The impact of women's anxiety and fear about childbirth needs further investigation.

There is policy interest in the screening and treatment of mental health problems in young people who offend, but the value of such screening is not yet known. To assess the diagnostic test accuracy of screening measures for mental health problems in young people who offend; to evaluate the clinical effectiveness and cost-effectiveness of screening and treatment; to model estimates of cost; to assess the evidence base for screening against UK National Screening Committee criteria; and to identify future research priorities. In total, 25 electronic databases including MEDLINE, PsycINFO, EMBASE and The Cochrane Library were searched from inception until April 2011. Reverse citation searches of included studies were undertaken and reference list of included studies were examined. Two reviewers independently examined titles and abstracts and extracted data from included studies using a standardised form. The inclusion criteria for the review were (1) population - young offenders (aged 10-21 years); (2) intervention/instrument - screening instruments for mental health problems, implementation of a screening programme or a psychological or pharmacological intervention as part of a clinical trial; (3) comparator - for diagnostic test accuracy studies, any standardised diagnostic interview; for trials, any comparator; (4) outcomes - details of diagnostic test accuracy, mental health outcomes over the short or longer term or measurement of cost data; and (5) study design - for diagnostic test accuracy studies, any design; for screening programmes, randomised controlled trials or controlled trials; for clinical effectiveness studies, randomised controlled trials; for economic studies, economic evaluations of screening strategies or interventions. Of 13,580 studies identified, nine, including eight independent samples, met the inclusion criteria for the diagnostic test accuracy and validity of screening measures review. Screening accuracy was typically modest. No studies examined the clinical effectiveness of screening, although 10 studies were identified that examined the clinical effectiveness of interventions for mental health problems. There were too few studies to make firm conclusions about the clinical effectiveness of treatments in this population. No studies met the inclusion criteria for the assessment of the cost-effectiveness of screening or treatment. An exemplar decision model was developed for depression, which identified a number of the likely key drivers of uncertainty, including the prevalence of unidentified mental health problems, the severity of mental health problems and their relationship to generic measures of outcome and the impact of treatment on recidivism. The information evaluated as part of the review was relevant to five of the UK National Screening Committee criteria. On the basis of the above results, none of the five criteria was met. The conclusions of the review are based on limited evidence. Conclusions are tentative and the decision model should be treated as an exemplar. Evidence on the clinical effectiveness and cost-effectiveness of screening for mental health problems in young people who offend is currently lacking. Future research should consider feasibility trials of clinical interventions to establish important parameters ahead of conducting definitive trials. Future diagnostic studies should compare the diagnostic test accuracy of a range of screening instruments, including those recommended for use in the UK in this population. These studies should be designed to reduce the decision uncertainty identified by the exemplar decision model. This study is registered as PROSPERO CRD42011001466. The National Institute for Health Research Health Technology Assessment programme.