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Papers by Dominic Trépel
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.
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
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.
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.
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.
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.
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
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.
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.
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.