Meg Wiggins

Postnatal support for mothers living in disadvantaged inner city areas: a randomised controlled trial

Study objective: To evaluate the effect of two forms of postnatal social support for disadvantaged inner city mothers on maternal and child health outcomes. Design: Randomised controlled trial with economic and process evaluations and follow up at 12 and 18 months. The two intervention groups received either the offer of a year of monthly supportive listening home visits by a support health visitor (SHV), or a year of support from community groups providing drop in sessions, home visiting and/or telephone support (CGS). Each was compared with a control group that received standard health visitor services. Setting: Two disadvantaged boroughs of London, United Kingdom. Participants: 731 women from culturally diverse backgrounds with infants. Main results: At 12 and 18 months, there was little impact for either intervention on the main outcomes: child injury (SHV: relative risk 0.99; 95% confidence intervals 0.68 to 1.45, CGS: 0.91; 0.61 to1.36), maternal smoking (SHV: 0.86; 0.62 to 1.19, CGS: 0.97; 0.72 to 1.33) or maternal depression (SHV: 0.86; 0.62 to1.19, CGS: 0.93; 0.69 to 1.27). SHV women had different patterns of health service use (with fewer taking their children to the GP) and had less anxious experiences of motherhood than control women. User satisfaction with the SHV intervention was high. Uptake of the CGS intervention was low: 19%, compared with 94% for the SHV intervention. Conclusions: There was no evidence of impact on the primary outcomes of either intervention among this culturally diverse population. The SHV intervention was associated with improvement in some of the secondary outcomes.

Health outcomes of youth development programme in England: prospective matched comparison study

Objective To evaluate the effectiveness of youth development in reducing teenage pregnancy, substance use, and other outcomes. Design Prospective matched comparison study. Setting 54 youth service sites in England. Participants Young people (n=2724) aged 13-15 years at baseline deemed by professionals as at risk of teenage pregnancy, substance misuse, or school exclusion or to be vulnerable. Intervention Intensive, multicomponent youth development programme including sex and drugs education (Young People’s Development Programme) versus standard youth provision. Main outcome measures Various, including pregnancy, weekly cannabis use, and monthly drunkenness at 18 months. Results Young women in the intervention group more commonly reported pregnancy than did those in the comparison group (16% v 6%; adjusted odds ratio 3.55, 95% confidence interval 1.32 to 9.50). Young women in the intervention group also more commonly reported early heterosexual experience (58% v 33%; adjusted odds ratio 2.53, 1.09 to 5.92) and expectation of teenage parenthood (34% v 24%; 1.61, 1.07 to 2.43). Conclusions No evidence was found that the intervention was effective in delaying heterosexual experience or reducing pregnancies, drunkenness, or cannabis use. Some results suggested an adverse effect. Although methodological limitations may at least partly explain these findings, any further implementation of such interventions in the UK should be only within randomised trials.

Using random allocation to evaluate social interventions: Three recent UK examples

Although widely accepted in medicine and health services research, randomized controlled trials (RCTs) are often viewed with hostility by social scientists, who cite a variety of reasons as to why this approach to evaluation cannot be used to research social interventions. This article discusses the three central themes in these debates, which are those of science, ethics, and feasibility. The article uses three recent U.K. trials of social interventions (day care for preschool children, social support for disadvantaged families, and peer-led sex education for young people) to consider issues relating to the use of random allocation for social intervention evaluation and to suggest some practical strategies for the successful implementation of “social” RCTs. The article argues that the criteria of science, ethics, and feasibility can and should apply to social intervention trials in just the same way as they do to clinical trials.

Effectiveness of a social support intervention on infant feeding practices: randomised controlled trial

Background: To assess whether monthly home visits from trained volunteers could improve infant feeding practices at age 12 months, a randomised controlled trial was carried out in two disadvantaged inner city London boroughs. Methods: Women attending baby clinics with their infants (312) were randomised to receive monthly home visits from trained volunteers over a 9-month period (intervention group) or standard professional care only (control group). The primary outcome was vitamin C intakes from fruit. Secondary outcomes included selected macro and micro-nutrients, infant feeding habits, supine length and weight. Data were collected at baseline when infants were aged approximately 10 weeks, and subsequently when the child was 12 and 18 months old. Results: Two-hundred and twelve women (68%) completed the trial. At both follow-up points no significant differences were found between the groups for vitamin C intakes from fruit or other nutrients. At first follow-up, however, infants in the intervention group were significantly less likely to be given goats’ or soya milks, and were more likely to have three solid meals per day. At the second follow-up, intervention group children were significantly less likely to be still using a bottle. At both follow-up points, intervention group children also consumed significantly more specific fruit and vegetables. Conclusions: Home visits from trained volunteers had no significant effect on nutrient intakes but did promote some other recommended infant feeding practices. Trial registration: Current Controlled Trials ISRCTN55500035

Including Culturally Diverse Samples in Health Research: A Case Study of an Urban Trial of Social Support

Objectives. To describe the recruitment procedures used in a study of Social Support and Family Health carried out in a disadvantaged urban area of the UK in 1999-2001; to consider the impact of using inclusive recruitment procedures on the final research sample and implications for the conduct of the research and data obtained. Design. Face-to-face recruitment of eligible women, using interpreters where necessary, to a randomized controlled trial of two alternative strategies for providing support to women with infants. Results. Of the 1,263 women eligible to enter the trial, 731 were successfully recruited. Forty-five languages other than English were spoken by eligible women; 14% needed an interpreter for the recruitment visit, and a further 30% spoke English as a second language. Inclusive recruitment practices added significant costs, resulted in a study sample with a different social profile from the sample that would have been achieved without these, and challenged some of the assumptions underlying the model of informed consent commonly used in much health services research. Conclusion. Procedures can be developed for recruiting people with diverse cultural backgrounds to take part in research. This helps to address the issue of possible bias in generalizing research findings by increasing external validity, and respects the ethic that everyone should have the right to be eligible for inclusion in research.

Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study.

BACKGROUND Type 1 diabetes (T1D) in children and young people is increasing worldwide with a particular increase in children under the age of 5 years. Fewer than one in six children and young people achieve glycosylated fraction of haemoglobin (HbA1c) values in the range identified as providing best future outcomes. There is an urgent need for clinic-based pragmatic, feasible and effective interventions that improve both glycaemic control and quality of life (QoL). The intervention offers both structured education, to ensure young people know what they need to know, and a delivery model designed to motivate self-management. OBJECTIVE To assess the feasibility of providing a clinic-based structured educational group programme incorporating psychological approaches to improve long-term glycaemic control, QoL and psychosocial functioning in a diverse range of young people. DESIGN The study was a pragmatic, cluster randomised control trial with integral process and economic evaluation. SETTING Twenty-eight paediatric diabetes services across London, south-east England and the Midlands. RANDOMISATION Minimised by clinic size, age (paediatric or adolescent) and specialisation (district general hospital clinic or teaching hospital/tertiary clinic). ALLOCATION Half of the sites were randomised to the intervention arm and half to the control arm. Allocation was concealed until after clinics had consented and the first participant was recruited. Where possible, families were blind to allocation until recruitment finished. PARTICIPANTS Forty-three health-care practitioners (14 teams) were trained in the intervention. The study recruited 362 children aged 8-16 years, diagnosed with T1D for > 12 months, with a mean 12-month HbA1c level of ≥ 8.5%. INTERVENTION Two 1-day workshops taught intervention delivery. A detailed manual and resources were provided. The intervention consists of four group education sessions led by a paediatric diabetes specialist nurse with another team member. OUTCOMES The primary outcome was glycaemic control, assessed at the individual level using venous HbA1c values, measured at baseline, 12 and 24 months. Secondary outcomes were directly and indirectly related to diabetes management, including hypoglycaemic episodes, hospital admissions, diabetes regimen, knowledge, skills and responsibility for diabetes management, intervention compliance, clinic utilisation, emotional and behavioural adjustment, and general and diabetes-specific QoL. PROCESS EVALUATION Questionnaires, semistructured interviews, informal discussion following observation sessions, fieldwork notes and case note review were used to collect qualitative and quantitative data from key stakeholder groups at specific time points in the trial. STATISTICAL ANALYSES Primary and secondary analyses were intention-to-treat comparisons of outcomes at 12 and 24 months, using analysis of covariance with a random effect for clinic. Prespecified subgroup analyses based on age, gender, initial HbA1c value and socioeconomic status were estimated from models that included an interaction term. The economic analysis compared long-term costs and predicted quality-adjusted life-years (QALYs). RESULTS The intervention did not improve HbA1c at 12 months [intervention effect 0.11; 95% confidence interval (CI) -0.28 to 0.50; p = 0.584] or 24 months (intervention effect 0.03; 95% CI -0.36 to 0.41; p = 0.891). A total of 298/362 patients (82.3%) provided blood samples at 12-month follow-up, and 284/362 (78.5%) provided blood samples at 24-month follow-up. Follow-up questionnaires were completed by 307 patients (85.3%) at 12 months and by 295 patients (81.5%) at 24 months. Intervention group parents at 12 months (95% CI 0.74; 0.03 to 1.52) and young people at 24 months (0.85; 95% CI 0.03 to 1.61) had higher scores on the diabetes family responsibility questionnaire. Young people reported reduced happiness with body weight at 12 months (-0.56; 95% CI -1.03 to -0.06). Only 68% of groups were run. Of the 180 families recruited, 96 (53%) attended at least one module. Reasons for low uptake included difficulties organising groups, and work and school commitments. Young people with higher HbA1c levels were less likely to attend. Parents and young people who attended groups described improved family relationships, improved knowledge and understanding, greater confidence and increased motivation to manage diabetes. Twenty-four months after the intervention, nearly half of the young people reported that the groups had made them want to try harder and that they had carried on trying. A high-quality, complex, pragmatic trial of structured education can be delivered alongside standard care in NHS diabetes clinics. Health-care providers benefited from behaviour change skill training and can deliver pragmatic aspects of a National Institute for Health and Care Excellence (NICE)-compliant structured education programme after relatively brief training. The process evaluation provides insight into aspects of the model, and highlights strengths and aspects that may have contributed to the failure to influence primary and secondary outcomes. Current NHS practice dominates CASCADE (Child and Adolescent Structured Competencies Approach to Diabetes Education) in that it achieves the same number of QALYs at a lower cost. The mean cost of providing the intervention was £5098 per site or £683 per child. Members of paediatric diabetes services trained to deliver the CASCADE structured education package using behaviour change techniques did not improve glycaemic control in patients compared with control subjects 1 and 2 years after the intervention. The training workshops for practitioners were well evaluated; however, more intensive training was needed. The intervention cost £683 per patient but was not cost-effective because it did not improve metabolic control. CONCLUSIONS A high-quality, complex, pragmatic trial of structured education can be successfully conducted alongside standard care in NHS diabetes clinics. Pragmatic components of a NICE-compliant structured education programme can be successfully delivered following a relatively brief 2-day training while paediatric health-care professionals benefit from training in behaviour change skills. The study provides invaluable information on barriers and opportunities regarding future, similar interventions. A low dropout rate and good attendance for the subgroup that attended the intervention suggests there might be improved uptake if offered to young people with lower HbA1c. Testing whether this approach can be more successful with a robust ongoing supervisory element should be a target of further research. TRIAL REGISTRATION Current Controlled Trials ISRCTN52537669. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 20. See the NIHR Journals Library website for further project information.

A qualitative study of uptake of free vitamins in England

Objective To identify reasons why eligible families are not accessing free ‘Healthy Start’ vitamin supplementation (providing vitamins A, C and D) in England. Design Qualitative study using in-depth interviews. Setting 13 primary care trusts in England. Participants Purposive sample of 15 Healthy Start coordinators, 50 frontline health and childrens professionals and 107 parents. Results Vitamin take-up was low across all research sites, reported as below 10% of eligible beneficiaries for free vitamins. Reasons identified by both parents and professionals included (1) poor accessibility of vitamins, (2) low promotion of the scheme by health professionals, (3) a lack of awareness among eligible families, and (4) low motivation among mothers to take vitamins for themselves during pregnancy or for children under 4 years old. Conclusions Low uptake rates can be explained by poor accessibility of vitamins and lack of awareness and motivation to take vitamin supplements among eligible families. Universal provision (at least for pregnant women) and better training for health professionals are identified as potential solutions worthy of further research and evaluation.

Implementing a structured education program for children with diabetes: lessons learnt from an integrated process evaluation.

Background There is recognition of an urgent need for clinic-based interventions for young people with type 1 diabetes mellitus that improve glycemic control and quality of life. The Child and Adolescent Structured Competencies Approach to Diabetes Education (CASCADE) is a structured educational group program, using psychological techniques, delivered primarily by diabetes nurses. Composed of four modules, it is designed for children with poor diabetic control and their parents. A mixed methods process evaluation, embedded within a cluster randomized control trial, aimed to assess the feasibility, acceptability, fidelity, and perceived impact of CASCADE. Methods 28 pediatric diabetes clinics across England participated and 362 children aged 8–16 years, with type 1 diabetes and a mean glycosylated hemoglobin (HbA1c) of 8.5 or above, took part. The process evaluation used a wide range of research methods. Results Of the 180 families in the intervention group, only 55 (30%) received the full program with 53% attending at least one module. Only 68% of possible groups were run. Staff found organizing the groups burdensome in terms of arranging suitable dates/times and satisfactory group composition. Some staff also reported difficulties in mastering the psychological techniques. Uptake, by families, was influenced by the number of groups run and by school, work and other commitments. Attendees described improved: family relationships; knowledge and understanding; confidence; motivation to manage the disease. The results of the trial showed that the intervention did not significantly improve HbA1c at 12 or 24 months. Conclusions Clinic-based structured group education delivered by staff using psychological techniques had perceived benefits for parents and young people. Staff and families considered it a valuable intervention, yet uptake was poor and the burden on staff was high. Recommendations are made to inform issues related to organization, design, and delivery in order to potentially enhance the impact of CASCADE and future programs. Current Controlled Trials ISRCTN52537669.

Involving Young People in Changing Their School Environment to Make It Safer: Findings from a Process Evaluation in English Secondary Schools.

Purpose – The purpose of this paper is to explore the process of involving students and staff on school action groups, and staff and student experiences of reviewing local data and initiating school-level changes, to address bullying and other aggression. Design/methodology/approach – The authors draw on qualitative, process data collected at four purposively sampled pilot intervention schools in England via semi-structured interviews with school managers, action group members and facilitators (n=33), focus groups with students (n=16) and staff (n=4), and observations. Findings – School staff used multiple methods to recruit a diverse range of students onto school action groups. Locally tailored data reports were an important catalyst for action groups to identify priorities and plan whole school change – both through the process of “validation” (whereby existing concerns were confirmed) and “discovery” (whereby new problems were identified). An unexpected benefit of providing schools with these data was that it triggered analyses of other data sources, including routine monitoring data. External facilitators were important in promoting student voice and ensuring the intervention retained integrity as a whole-school restorative approach. Practical implications – It was feasible to involve young people using action groups, and there was evidence of school-level actions led by students, including in disadvantaged school contexts. Future Health Promoting Schools interventions could incorporate this approach to support locally appropriate, school-level change. Originality/value – The micro-level processes that were observed, whereby action groups interrogated feedback reports and collected additional data, suggest the responsiveness of such youth-involvement interventions to local needs. Contrary to many public health interventions, implementation appeared to be facilitated rather than hindered by features of the secondary-school “market” whereby parents have some choice between schools.

Effectiveness of a structured educational intervention using psychological delivery methods in children and adolescents with poorly controlled type 1 diabetes: a cluster-randomized controlled trial of the CASCADE intervention

Introduction Type 1 diabetes (T1D) in children and adolescents is increasing worldwide with a particular increase in children <5 years. Fewer than 1 in 6 children and adolescents achieve recommended glycated hemoglobin (HbA1c) values. Methods A pragmatic, cluster-randomized controlled trial assessed the efficacy of a clinic-based structured educational group incorporating psychological approaches to improve long-term glycemic control, quality of life and psychosocial functioning in children and adolescents with T1D. 28 pediatric diabetes services were randomized to deliver the intervention or standard care. 362 children (8–16 years) with HbA1c≥8.5% were recruited. Outcomes were HbA1c at 12 and 24 months, hypoglycemia, admissions, self-management skills, intervention compliance, emotional and behavioral adjustment, and quality of life. A process evaluation collected data from key stakeholder groups in order to evaluate the feasibility of delivering the intervention. Results 298/362 patients (82.3%) provided HbA1c at 12 months and 284/362 (78.5%) at 24 months. The intervention did not improve HbA1c at 12 months (intervention effect 0.11, 95% CI −0.28 to 0.50, p=0.584), or 24 months (intervention effect 0.03, 95% CI −0.36 to 0.41, p=0.891). There were no significant changes in remaining outcomes. 96/180 (53%) families in the intervention arm attended at least 1 module. The number of modules attended did not affect outcome. Reasons for low uptake included difficulties organizing groups and work and school commitments. Those with highest HbA1cs were less likely to attend. Mean cost of the intervention was £683 per child. Conclusions Significant challenges in the delivery of a structured education intervention using psychological techniques to enhance engagement and behavior change delivered by diabetes nurses and dietitians in routine clinical practice were found. The intervention did not improve HbA1c in children and adolescents with poor control. Trial registration number ISRCTN52537669, results.