Using a pragmatically adapted, low-cost contingency management intervention to promote heroin abstinence in individuals undergoing treatment for heroin use disorder in UK drug services (PRAISE): a cluster randomised trial.

INTRODUCTION: Most individuals treated for heroin use disorder receive opioid agonist treatment (OAT)(methadone or buprenorphine). However, OAT is associated with high attrition and persistent, occasional heroin use. There is some evidence for the effectiveness of contingency management (CM), a behavioural intervention involving modest financial incentives, in encouraging drug abstinence when applied adjunctively with OAT. UK drug services have a minimal track record of applying CM and limited resources to implement it. We assessed a CM intervention pragmatically adapted for ease of implementation in UK drug services to promote heroin abstinence among individuals receiving OAT. DESIGN: Cluster randomised controlled trial. SETTING AND PARTICIPANTS: 552 adults with heroin use disorder (target 660) enrolled from 34 clusters (drug treatment clinics) in England between November 2012 and October 2015. INTERVENTIONS: Clusters were randomly allocated 1:1:1 to OAT plus 12× weekly appointments with: (1) CM targeted at opiate abstinence at appointments (CM Abstinence); (2) CM targeted at on-time attendance at appointments (CM Attendance); or (3) no CM (treatment as usual; TAU). Modifications included monitoring behaviour weekly and fixed incentives schedule. MEASUREMENTS: Primary outcome: heroin abstinence measured by heroin-free urines (weeks 9-12). SECONDARY OUTCOMES: heroin abstinence 12 weeks after discontinuation of CM (weeks 21-24); attendance; self-reported drug use, physical and mental health. RESULTS: CM Attendance was superior to TAU in encouraging heroin abstinence. Odds of a heroin-negative urine in weeks 9-12 was statistically significantly greater in CM Attendance compared with TAU (OR=2.1; 95% CI 1.1 to 3.9; p=0.030). CM Abstinence was not superior to TAU (OR=1.6; 95% CI 0.9 to 3.0; p=0.146) or CM Attendance (OR=1.3; 95% CI 0.7 to 2.4; p=0.438) (not statistically significant differences). Reductions in heroin use were not sustained at 21-24 weeks. No differences between groups in self-reported heroin use. CONCLUSIONS: A pragmatically adapted CM intervention for routine use in UK drug services was moderately effective in encouraging heroin abstinence compared with no CM only when targeted at attendance. CM targeted at abstinence was not effective. TRIAL REGISTRATION NUMBER: ISRCTN 01591254.

Children overcoming picky eating (COPE) - A cluster randomised controlled trial.

OBJECTIVES: Food neophobia limits dietary variety in children and adults. Interventions to alleviate the impact of neophobia on children's dietary variety have had varying success. The potential effectiveness of mindfulness, a process of bringing awareness to the present moment, has received little attention. This trial aimed to explore the effectiveness of two mindfulness exercises on novel food acceptance for children. METHODS: A cluster-randomised controlled trial with three trial arms compared the impact of two mindfulness exercises (mindful breathing and mindful raisin-eating) and a non-mindful control task on anticipated liking and intake of a novel fruit. Seventy-one children aged 10-12 years engaged in one of the three tasks at school over five days and were offered a novel fruit at the end of the intervention. Children self-reported mindfulness, food neophobia and anxiety at baseline and follow-up. RESULTS: Two mixed-effects models showed that, controlling for school effects and covariates (including mindfulness, food neophobia and anxiety), children in the mindful raisin-eating arm reported greater anticipated liking of a novel fruit and children in both mindfulness arms consumed greater amounts of a novel fruit than children in the control arm. Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm. CONCLUSIONS: The results provide promising evidence for the potential effectiveness of mindfulness interventions in encouraging children to try new foods. The mechanisms underlying effectiveness remain unclear and further research, exploring long-term effects and the possibility to generalise these findings to other food groups such as vegetables, is needed.

Interactive effects of impulsivity and dietary restraint over snack intake in children.

Impulsivity and dietary restraint have been found to interact to affect dietary intake in adults. Few studies have explored this effect in children. The current study therefore aimed to investigate the interactive effects of behavioural impulsivity and dietary restraint on intake. Fifty 7-11-year-olds participated in this laboratory-based study. Impulsivity was assessed through behavioural tasks measuring a number of impulsivity facets. Children self-reported dietary restraint. Children visited the lab and had access to a range of snack foods; intake was recorded. Hunger at arrival was assessed. A series of 2 x 2 between-subjects ANCOVAs indicated that motor impulsivity and dietary restraint interacted to affect intake. Reward sensitivity, delay of gratification and inhibitory control did not interact with dietary restraint. Post-hoc analyses indicated that children high in motor impulsivity and restraint ate significantly more snacks than restrained children low in motor impulsivity. Furthermore, children low in motor impulsivity but high in dietary restraint were better at inhibiting their intake than children low in impulsivity and dietary restraint. The results indicate that high levels of impulsivity or dietary restraint in isolation do not affect children's dietary intake but that their combination may lead to overeating in food rich environments.

Multiple measures of impulsivity, eating behaviours and adiposity in 7-11-year-olds.

Previous research suggests that the relationship between the multiple aspects of children's impulsivity, eating behaviour and adiposity may depend on measures used. Fifty 7-11-year-olds (28 female, 22 male) completed four impulsivity tasks (Go/No-Go, Door Opening, Circle Drawing, Delay Discounting), consumed a snack, reported on their eating, and were weighed and measured. Parents completed measures of child impulsivity and eating behaviour. Impulsivity and adiposity were positively correlated. Lower rates of delay discounting were associated with lower snack intake. Ability to inhibit a pre-potent response was related to dietary restraint and snack intake. Findings suggest a complex, multifaceted relationship between impulsivity, eating and adiposity, which are measure and respondent dependent.

A pilot feasibility randomised controlled trial of an adjunct brief social network intervention in opiate substitution treatment services.

BACKGROUND: Approximately 3% of people receiving opioid substitution therapy (OST) in the UK manage to achieve abstinence from prescribed and illicit drugs within three years of commencing treatment. Involvement of families and wider social networks in supporting psychological treatment may be an effective strategy in facilitating recovery, and this pilot study aimed to evaluate the impact of a social network-focused intervention for patients receiving OST. METHODS: A two-site, open feasibility trial randomised patients receiving OST for at least 12 months but still reporting illicit opiate use in the past 28 days to one of three treatments: 1) treatment as usual (TAU), 2) Brief Social Behaviour and Network Therapy (B-SBNT) + TAU, or 3) Personal Goal Setting (PGS) + TAU. The two active interventions consisted of 4 sessions. There were 3 aims: 1) test the feasibility of recruiting OST patients to a trial of B-SBNT, and following them up over 12 months; 2) test the feasibility of training clinicians to deliver B-SBNT; 3) test whether B-SBNT reduces heroin use 3 and 12 months after treatment, and to explore potential mediating factors. The primary outcome for aim 3 was number of days of heroin use in the past month, and a range of secondary outcome measures were specified in advance (level of drug dependence, mental health, social satisfaction, therapist rapport, treatment satisfaction, social network size and support). RESULTS: A total of 83 participants were randomised, and 70 (84%) were followed-up at 12 months. Fidelity analysis of showed that B-SBNT sessions were clearly distinguishable from PGS and TAU sessions, suggesting it was possible to train clinical staff to an adequate level of competence. No significant differences were found between the 3 intervention arms in the primary or secondary outcome measures. Attendance at psychosocial treatment intervention sessions was low across all three arms (44% overall). CONCLUSIONS: Patients receiving OST can be recruited into a trial of a social network-based intervention, but poor attendance at treatment sessions makes it uncertain whether an adequate dose of treatment was delivered. In order to achieve the benefits of psychosocial interventions, further work is needed to overcome poor engagement. TRIAL REGISTRATION: ISRCTN Trial Registration Number: ISRCTN22608399 . Date of registration: 27/04/2012. Date of first randomisation: 14/08/2012.

Measuring Health and Broader Well-Being Benefits in the Context of Opiate Dependence: The Psychometric Performance of the ICECAP-A and the EQ-5D-5L.

BACKGROUND: Measuring outcomes in economic evaluations of social care interventions is challenging because both health and well-being benefits are evident. The ICEpop CAPability instrument for adults (ICECAP-A) and the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) are measures potentially suitable for the economic evaluation of treatments for substance use disorders. Evidence for their validity in this context is, however, lacking. OBJECTIVES: To assess the construct validity of the ICECAP-A and the EQ-5D-5L in terms of convergent and discriminative validity and sensitivity to change on the basis of standard clinical measures (Clinical Outcomes in Routine Evaluation-Outcome Measure, Treatment Outcomes Profile, Interpersonal Support Evaluation List, Leeds Dependence Questionnaire, and Social Satisfaction Questionnaire). METHODS: A secondary analysis of pilot trial data for heroin users in opiate substitution treatment was conducted. Baseline convergence with clinical measures was assessed using the Pearson correlation coefficient. Discriminative validity was assessed using one-way analysis of variance and stepwise regressions. Sensitivity to changes in clinical indicators was assessed at 3 and 12 months using the standardized response mean statistic and parametric and nonparametric testing. RESULTS: Both measures had the same level of construct validity, except for clinical indicators of well-being, for which the ICECAP-A performed better. The ICECAP-A was sensitive to changes in both health and well-being indicators. The EQ-5D-5L had lower levels of sensitivity to change, and a ceiling effect (27%), particularly evident in the dimensions of self-care (89%), mobility (75%), and usual activities (72%). CONCLUSIONS: The findings support the construct validity of both measures, but the ICECAP-A gives more attention to broader impacts and is more sensitive to change. The ICECAP-A shows promise in evaluating treatments for substance use disorders for which recovery is the desired outcome.

Parental modelling and prompting effects on acceptance of a novel fruit in 2-4-year-old children are dependent on children's food responsiveness.

Few children consume the recommended portions of fruit or vegetables. This study examined the effects of parental physical prompting and parental modelling in children's acceptance of a novel fruit (NF) and examined the role of children's food-approach and food-avoidance traits on NF engagement and consumption. A total of 120 caregiver-child dyads (fifty-four girls, sixty-six boys) participated in this study. Dyads were allocated to one of the following three conditions: physical prompting but no modelling, physical prompting and modelling or a modelling only control condition. Dyads ate a standardised meal containing a portion of a fruit new to the child. Parents completed measures of children's food approach and avoidance. Willingness to try the NF was observed, and the amount of the NF consumed was measured. Physical prompting but no modelling resulted in greater physical refusal of the NF. There were main effects of enjoyment of food and food fussiness on acceptance. Food responsiveness interacted with condition such that children who were more food responsive had greater NF acceptance in the prompting and modelling conditions in comparison with the modelling only condition. In contrast, children with low food responsiveness had greater acceptance in the modelling control condition than in the prompting but no modelling condition. Physical prompting in the absence of modelling is likely to be detrimental to NF acceptance. Parental use of physical prompting strategies, in combination with modelling of NF intake, may facilitate acceptance of NF, but only in food-responsive children. Modelling consumption best promotes acceptance in children with low food responsiveness.

Rated and measured impulsivity in children is associated with diminished cardiac reactions to acute psychological stress.

This study examined the association between impulsivity and heart rate reactions to a brief psychological stress in pre-adolescent children. Impulsivity was assessed by two response inhibition tasks and maternal self-report. Heart rate was measured at rest and in response to a mental arithmetic challenge. Children high in impulsivity showed blunted cardiac stress reactions. This result resonates with previous findings that blunted stress reactivity is characteristic of a range of problematic behaviours often associated with impulsivity.

Measuring hunger and satiety in primary school children. Validation of a new picture rating scale.

Measuring hunger and satiety in children is essential to many studies of childhood eating behaviour. Few validated measures currently exist that allow children to make accurate and reliable ratings of hunger/satiety. Three studies aimed to validate the use of a new categorical rating scale in the context of estimated and real eating episodes. Forty-seven 6- to 8-year-olds participated in Study 1, which used a between-participant design. Results indicated that the majority of children were able to make estimated hunger/satiety ratings for a story character using the scale. No significant differences in the ratings of hunger/satiety of children measured before and after lunch were observed and likely causes are discussed. To account for inter-individual differences in hunger/satiety perceptions Study 2 employed a within-participant design. Fifty-four 5- to 7-year-olds participated and made estimated hunger/satiety ratings for a story character and real hunger/satiety ratings before and after lunch. The results indicated that the majority of children were able to use the scale to make estimated and real hunger and satiety ratings. Children were found to be significantly hungrier before compared to after lunch. As it was not possible to establish the types and quantities of food children ate for lunch a third study was carried out in a controlled laboratory environment. Thirty-six 6- to 9-year-olds participated in Study 3 and made hunger/satiety ratings before and after ingesting an ad libitum snack of known composition and quantity. Results indicated that children felt hungrier before than after the snack and that pre-snack hunger/satiety, and changes in hunger/satiety, were associated with snack intake. Overall, the studies indicate that the scale has potential for use with primary school children. Implications of the findings are discussed.

Predicting successful introduction of novel fruit to preschool children.

BACKGROUND: Few children eat sufficient fruits and vegetables despite their established health benefits. The feeding practices used by parents when introducing novel foods to their children, and their efficacy, require further investigation. OBJECTIVE: We aimed to establish which feeding strategies parents commonly use when introducing a novel fruit to their preschool-aged children and assess the effectiveness of these feeding strategies on children's willingness to try a novel fruit. DESIGN: Correlational design. PARTICIPANTS/SETTING: Twenty-five parents and their children aged 2 to 4 years attended our laboratory and consumed a standardized lunch, including a novel fruit. Interactions between parent and child were recorded and coded. STATISTICAL ANALYSES PERFORMED: Pearson's correlations and multiple linear regression analyses. RESULTS: The frequency with which children swallowed and enjoyed the novel fruit, and the frequency of taste exposures to the novel fruit during the meal, were positively correlated with parental use of physical prompting and rewarding/bargaining. Earlier introduction of solids was related to higher frequency of child acceptance behaviors. The child's age at introduction of solids and the number of physical prompts displayed by parents significantly predicted the frequency of swallowing and enjoying the novel fruit. Age of introduction to solids and parental use of rewards/bargaining significantly predicted the frequency of taste exposures. CONCLUSIONS: Prompting a child to eat and using rewards or bargains during a positive mealtime interaction can help to overcome barriers to novel fruit consumption. Early introduction of solids is also associated with greater willingness to consume a novel fruit.