The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial.

The aim of the Youth Depression Alleviation-Combined Treatment (YoDA-C) study is to determine whether antidepressant medication should be started as a first-line treatment for youth depression delivered concurrently with psychotherapy. Doubts about the use of medication have been raised by meta-analyses in which the efficacy and safety of antidepressants in young people have been questioned, and subsequent treatment guidelines for youth depression have provided only qualified support.

Youth Depression Alleviation-Augmentation with an anti-inflammatory agent (YoDA-A): protocol and rationale for a placebo-controlled randomized trial of rosuvastatin and aspirin

AIM: There is growing support for the role of inflammation and oxidative stress in the pathophysiology of major depressive disorder (MDD). This has led to the development of novel strategies targeting inflammation in the treatment of depression. Rosuvastatin and aspirin have well-documented, anti-inflammatory and antioxidant properties. The aim of the Youth Depression Alleviation: Augmentation with an anti-inflammatory agent (YoDA-A) study is to determine whether individuals receiving adjunctive anti-inflammatory agents, aspirin and rosuvastatin experience a reduction in the severity of MDD compared with individuals receiving placebo. METHODS: YoDA-A is a 12-week triple-blind, randomized controlled trial funded by the National Health and Medical Research Council, Australia. Participants aged 15-25, with moderate-to-severe MDD, are allocated to receive either 10 mg/day rosuvastatin, 100 mg/day aspirin, or placebo, in addition to treatment as usual. Participants are assessed at baseline and at weeks 4, 8, 12 and 26. The primary outcome is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 12. RESULTS: The study is planned to be completed in 2017. At date of publication, 85 participants have been recruited. CONCLUSION: Timely and targeted intervention for youth MDD is crucial. Given the paucity of new agents to treat youth MDD, adjunctive trials are not only pragmatic and 'real-world', but additionally aim to target shortfalls in conventional medications. This study has the potential to first provide two new adjunctive treatment options for youth MDD; aspirin and rosuvastatin. Second, this study will serve as proof of principle of the role of inflammation in MDD.

A longitudinal study of risk and protective factors associated with successful transition to secondary school in youth with ADHD: prospective cohort study protocol

BACKGROUND: Attention-Deficit/Hyperactivity Disorder (ADHD) has a significant impact on child and adolescent development, especially in relation to school functioning and academic outcomes. Despite the transition to high school being a potentially critical period for children with ADHD, most research in this period has focused on academic outcomes. This study aims to extend previous research by describing academic, school engagement, behaviour and social-emotional outcomes for young people with ADHD in the first and third years of high school and to identify risk and protective factors predictive of differing outcomes across these four domains. METHODS AND DESIGN: The Moving Up study is a longitudinal, prospective cohort study of children with ADHD as they transition and adjust to high school (age 12-15 years). Data are collected through direct assessment and child, parent and teacher surveys. The primary outcome is academic achievement, obtained by linking to standardised test results. Secondary outcomes include measures of behaviour, ADHD symptoms, school engagement (attitudes and attendance), and social and emotional functioning, including depressive symptoms. The mean performance of the study cohort on each outcome measure will be compared to the population mean for same aged children, using t-tests. Risk and protective factors to be examined using multiple regression include a child, family and school factors know to impact academic and school functioning. DISCUSSION: The Moving up study is the first Australian study prospectively designed to measure a broad range of student outcomes for children with ADHD during the high school transition period. Examining both current (cross sectional) and earlier childhood (longitudinal) factors gives us the potential to learn more about risk and protective factors associated with school functioning in young people with ADHD. The richness and depth of this information could lead to more targeted and effective interventions that may alter academic and wellbeing trajectories for young people at risk of poor outcomes. The study is approved by The Royal Children's Hospital Melbourne Human Research Ethics Committee (33206). Findings will be disseminated through peer-reviewed journals and conference presentations.

Scaling-up an efficacious school-based physical activity intervention: study protocol for the 'Internet-based professional learning to help teachers support activity in youth' (iPLAY) cluster randomized controlled trial and scale-up implementation evaluat

BACKGROUND: Despite the health benefits of regular physical activity, most children are insufficiently active. Schools are ideally placed to promote physical activity; however, many do not provide children with sufficient in-school activity or ensure they have the skills and motivation to be active beyond the school setting. The aim of this project is to modify, scale up and evaluate the effectiveness of an intervention previously shown to be efficacious in improving children's physical activity, fundamental movement skills and cardiorespiratory fitness. The 'Internet-based Professional Learning to help teachers support Activity in Youth' (iPLAY) study will focus largely on online delivery to enhance translational capacity.

METHODS/DESIGN: The intervention will be implemented at school and teacher levels, and will include six components: (i) quality physical education and school sport, (ii) classroom movement breaks, (iii) physically active homework, (iv) active playgrounds, (v) community physical activity links and (vi) parent/caregiver engagement. Experienced physical education teachers will deliver professional learning workshops and follow-up, individualized mentoring to primary teachers (i.e., Kindergarten - Year 6). These activities will be supported by online learning and resources. Teachers will then deliver the iPLAY intervention components in their schools. We will evaluate iPLAY in two complementary studies in primary schools across New South Wales (NSW), Australia. A cluster randomized controlled trial (RCT), involving a representative sample of 20 schools within NSW (1:1 allocation at the school level to intervention and attention control conditions), will assess effectiveness and cost-effectiveness at 12 and 24 months. Students' cardiorespiratory fitness will be the primary outcome in this trial. Key secondary outcomes will include students' moderate-to-vigorous physical activity (via accelerometers), fundamental movement skill proficiency, enjoyment of physical education and sport, cognitive control, performance on standardized tests of numeracy and literacy, and cost-effectiveness. A scale-up implementation study guided by the RE-AIM framework will evaluate the reach, effectiveness, adoption, implementation, and maintenance of the intervention when delivered in 160 primary schools in urban and regional areas of NSW.

DISCUSSION: This project will provide the evidence and a framework for government to guide physical activity promotion throughout NSW primary schools and a potential model for adoption in other states and countries.

Adolescent depressive disorders and family based interventions in the family options multicenter evaluation: study protocol for a randomized controlled trial

Background
There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services.

Methods/Design
The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention.

Cognitive-reminiscence therapy and usual care for depression in young adults: study protocol for a randomized controlled trial

Background
Depression is a common affliction for young adults, and is associated with a range of adverse outcomes. Cognitive-reminiscence therapy is a brief, structured intervention that has been shown to be highly effective for reducing depressive symptoms, yet to date has not been evaluated in young adult populations. Given its basis in theory-guided reminiscence-based therapy, and incorporation of effective therapeutic techniques drawn from cognitive therapy and problem-solving frameworks, it is hypothesized to be effective in treating depression in this age group.

Methods and design
This article presents the design of a randomized controlled trial implemented in a community-based youth mental health service to compare cognitive-reminiscence therapy with usual care for the treatment of depressive symptoms in young adults. Participants in the cognitive-reminiscence group will receive six sessions of weekly, individual psychotherapy, whilst participants in the usual-care group will receive support from the youth mental health service according to usual procedures. A between-within repeated-measures design will be used to evaluate changes in self-reported outcome measures of depressive symptoms, psychological wellbeing and anxiety across baseline, three weeks into the intervention, post-intervention, one month post-intervention and three months post-intervention. Interviews will also be conducted with participants from the cognitive-reminiscence group to collect information about their experience receiving the intervention, and the process underlying any changes that occur.

Discussion
This study will determine whether a therapeutic approach to depression that has been shown to be effective in older adult populations is also effective for young adults. The expected outcome of this study is the validation of a brief, evidence-based, manualized treatment for young adults with depressive symptoms.

Out & online; effectiveness of a tailored online multi-symptom mental health and wellbeing program for same-sex attracted young adults: study protocol for a randomised controlled trial

Same-sex attracted young adults have been found to experience higher rates of mental health problems and greater difficulties in accessing specialist mental health care services compared to their heterosexual peers. Internet-based mental health interventions have the potential to be more engaging and accessible to young adults compared to those delivered face-to-face. However, they are rarely inclusive of lesbian women and gay men. Thus, the current study aims to evaluate the effectiveness of an online mental health and wellbeing program, Out & Online (http://www.outandonline.org.au), in comparison to a wait-list control group, for reducing anxiety and depressive symptoms in same-sex attracted young adults aged between 18 and 25 years.