DO IT Trial: vitamin D Outcomes and Interventions in Toddlers - a TARGet Kids! randomized controlled trial.

BackgroundVitamin D levels are alarmingly low (<75 nmol/L) in 65-70% of North American children older than 1 year. An increased risk of viral upper respiratory tract infections (URTI), asthma-related hospitalizations and use of anti-inflammatory medication have all been linked with low vitamin D. No study has determined whether wintertime vitamin D supplementation can reduce the risk of URTI and asthma exacerbations, two of the most common and costly illnesses of early childhood. The objectives of this study are: 1) to compare the effect of 'high dose' (2000 IU/day) vs. 'standard dose' (400 IU/day) vitamin D supplementation in achieving reductions in laboratory confirmed URTI and asthma exacerbations during the winter in preschool-aged Canadian children; and 2) to assess the effect of 'high dose' vitamin D supplementation on vitamin D serum levels and specific viruses that cause URTI.Methods/designThis study is a pragmatic randomized controlled trial. Over 4 successive winters we will recruit 750 healthy children 1-5 years of age. Participating physicians are part of a primary healthcare research network called TARGet Kids!. Children will be randomized to the 'standard dose' or 'high dose' oral supplemental vitamin D for a minimum of 4 months (200 children per group). Parents will obtain a nasal swab from their child with each URTI, report the number of asthma exacerbations and complete symptom checklists. Unscheduled physician visits for URTIs and asthma exacerbations will be recorded. By May, a blood sample will be drawn to determine vitamin D serum levels. The primary analysis will be a comparison of URTI rate between study groups using a Poisson regression model. Secondary analyses will compare vitamin D serum levels, asthma exacerbations and the frequency of specific viral agents between groups.DiscussionIdentifying whether vitamin D supplementation of preschoolers can reduce wintertime viral URTIs and asthma exacerbations and what dose is optimal may reduce population wide morbidity and associated health care and societal costs. This information will assist in determining practice and health policy recommendations related to vitamin D supplementation in healthy Canadian preschoolers

Dynamic interpersonal therapy for moderate to severe depression: A pilot randomized controlled and feasibility trial

Background: Improving Access to Psychological Therapies (IAPT) services treat most patients in England who present to primary care with major depression. Psychodynamic psychotherapy is one of the psychotherapies offered. Dynamic Interpersonal Therapy (DIT) is a psychodynamic and mentalization-based treatment for depression. 16 sessions are delivered over approximately 5 months. Neither DIT's effectiveness relative to low-intensity treatment (LIT), nor the feasibility of randomizing patients to psychodynamic or cognitive-behavioural treatments (CBT) in an IAPT setting has been demonstrated. Methods: 147 patients were randomized in a 3:2:1 ratio to DIT (n = 73), LIT (control intervention; n = 54) or CBT (n = 20) in four IAPT treatment services in a combined superiority and feasibility design. Patients meeting criteria for major depressive disorder were assessed at baseline, mid-treatment (3 months) and post-treatment (6 months) using the Hamilton Rating Scale for Depression (HRSD-17), Beck Depression Inventory-II (BDI-II) and other self-rated questionnaire measures. Patients receiving DIT were also followed up 6 months post-completion. Results: The DIT arm showed significantly lower HRSD-17 scores at the 6-month primary end-point compared with LIT (d = 0.70). Significantly more DIT patients (51%) showed clinically significant change on the HRSD-17 compared with LIT (9%). The DIT and CBT arms showed equivalence on most outcomes. Results were similar with the BDI-II. DIT showed benefit across a range of secondary outcomes.ConclusionsDIT delivered in a primary care setting is superior to LIT and can be appropriately compared with CBT in future RCTs

Framework analysis: a worked example of a study exploring young people’s experiences of depression

Framework analysis is an approach to qualitative research which is being increasingly used across multiple disciplines, including psychology, social policy and nursing research. The stages of framework analysis have been described in published work, but the literature is lacking in articles describing how to conduct it in practice, particularly in the field of psychology, where researchers may be working as part of a team. Having used framework analysis on a study exploring adolescents' experiences of depression, we faced various challenges along the way and learned from experience how to use this approach to qualitative analysis. In this reflective article, we describe a worked example of using framework, which we hope will assist other researchers in deciding if this approach is suitable for their own research, and will provide guidance on how one might go about conducting framework analysis when working as part of a research team. We conclude that framework is a valuable contribution to qualitative methods in psychology, offering a pragmatic, flexible and rigorous approach to data analysis

‘Just like talking to someone about like shit in your life and stuff, and they help you’: hopes and expectations for therapy among depressed adolescents

Objective: To explore hopes and expectations for therapy among a clinical population of depressed adolescents. Method: As part of a randomised clinical trial, 77 adolescents aged 11 to 17, with moderate to severe depression, were interviewed using a semi-structured interview schedule. The interviews were analysed qualitatively, using Framework Analysis. Results: The findings are reported around five themes: “The difficulty of imagining what will happen in therapy”, "the 'talking cure'"; “the therapist as doctor”, “therapy as a relationship” and “regaining the old self or developing new capacities”. Conclusions: Differing expectations are likely to have implications for the way young people engage with treatment, and failure to identify these expectations may lead to a risk of treatment breakdown

Lack of trust in maternal support is associated with negative interpretations of ambiguous maternal behavior

Attachment theory assumes that children who lack trust in maternal availability for support are more inclined to interpret maternal behavior in congruence with their expectation that mother will remain unavailable for support. To provide the first test of this assumption, early adolescents (9-13 years old) were asked to assess whether ambiguous interactions with mother should be interpreted in a positive or a negative way. In our sample (n = 322), results showed that early adolescents' lack of trust in their mother's availability for support was related to more negative interpretations of maternal behavior. The associations remained significant after controlling for depressive mood. The importance of these findings for our understanding of attachment theory, attachment stability, and clinical practice are discussed

Beyond a diagnosis: the experience of depression among clinically-referred adolescents

Policy-makers have identified an urgent need to improve our ability to detect and diagnose depression in adolescents. This study aims to explore the lived experience of depression in clinically referred adolescents. 77 adolescents, aged between 11 and 17 with moderate to severed depression, were interviewed as part of a randomised controlled trial, using the Expectations of Therapy interview. Data were analysed qualitatively using framework analysis, with a focus on how the adolescents spoke about their depression. The study identified five themes: 1) Misery, despair and tears; 2) Anger and violence towards self and others; 3) A bleak view of everything; 4)Isolation and cutting off from the world; and 5) The impact on education. Researchers and policy-makers need to develop an understanding of depression grounded in the experiences of adolescents to improve detection and diagnosis of depression

Parents’ understanding and motivation to take part in a randomized controlled trial in the field of adolescent mental health: A Qualitative Study

Background Little is known about why parents agree to take part in randomized controlled trials for adolescent mental health. This study aimed to investigate parents’ perspectives on participating in a trial for psychological treatment of depression. The study explored parents’ motivations, understanding of the trial and perspectives on the acceptability of the trial. Methods Sixty-five parents took part in this qualitative study. Their adolescent children had been randomly allocated to one of three active psychological treatments for depression as part of the IMPACT trial and were interviewed about their experiences of participating in the study. Semi-structured interviews were analysed using framework analysis. Results For seven of the sixty-five parents, their experience of taking part in the trial was not covered in their interview so they were excluded from the analysis. The analysis was therefore based on the data from the parents of 58 adolescents taking part in the trial. The most commonly cited motivation for taking part in the study reported by parents was a desire to help others going through similar difficulties. Parents generally reported finding trial participation acceptable, although there were aspects that some reported finding less acceptable, including randomization and the burden of research assessments. Others spoke positively about the experience of trial participation and found it enjoyable or even therapeutic. Importantly, some did not appear to have a good understanding of the trial design, including randomization and treatment allocation. Conclusions This study indicates that trial participation can be a positive experience for parents, yet it raises concerns about how trialists can ensure that consent is fully informed, given that some parents appeared to have a poor understanding of the trial. Future studies should seek to explore how communication with trial participants can be improved, to ensure that trial participation is fully informed. Patient and public involvement will be crucial in ensuring this communication is accessible to stakeholders