scholarly journals A Study Exploring the Implementation of an Equine Assisted Intervention for Young People with Mental Health and Behavioural Issues

J ◽  
2019 ◽  
Vol 2 (2) ◽  
pp. 236-246
Author(s):  
Ann Hemingway
Keyword(s):  
Mental Health ◽  
Young People ◽  
Exploratory Study ◽  
Randomised Control Trial ◽  
Control Group ◽  
Target Groups ◽  
Randomised Controlled ◽  
Study Designs ◽  
Equine Assisted ◽  
Existing Data

This paper presents the findings from a study of an equine assisted intervention (EAI), which is currently referred over 150 predominantly young people with mental health and behavioural problems each year. The young people are referred to this intervention when other services such as Child & Adolescent Mental Health Services (CAMHS) are not effective. Performing an exploratory study of implementation may be indicated when, there are few previously published studies or existing data using a specific intervention technique. This study showed some positive changes for participants across eight dimensions including; assertiveness, engagement with learning, calmness, planning, taking responsibility, empathy, communication and focus and perseverance. The equine intervention literature has shown mixed results across a variety of study designs and target groups, in terms of the gold standard of evidence, randomised controlled studies however the evidence currently is very limited. This study used a non-randomised sample, no control group and an unstandardised measurement filled out by those who refer young people to the intervention (social workers and teachers). The outcomes however from this exploratory study would suggest that a randomised control trial may be warranted and achievable.

scholarly journals Treating sleep problems in young people at ultra-high-risk of psychosis: study protocol for a single-blind parallel group randomised controlled feasibility trial (SleepWell)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e045235
Author(s):  
Felicity Waite ◽  
Thomas Kabir ◽  
Louise Johns ◽  
Jill Mollison ◽  
Apostolos Tsiachristas ◽  
...  
Keyword(s):  
Mental Health ◽  
High Risk ◽  
Young People ◽  
Sleep Problems ◽  
Qualitative Interviews ◽  
Feasibility Trial ◽  
Psychotic Experiences ◽  
Post Intervention ◽  
Ultra High Risk ◽  
Randomised Controlled

BackgroundEffective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis.Methods and analysisA randomised controlled feasibility trial will be conducted. Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants’ views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures.Ethics and disseminationThe trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.Trial registration numberISRCTN85601537.

scholarly journals M.I.C.E—Mental Health Intervention for Children with Epilepsy: a randomised controlled, multi-centre clinical trial evaluating the clinical and cost-effectiveness of MATCH-ADTC in addition to usual care compared to usual care alone for children and young people with common mental health disorders and epilepsy—study protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sophie D. Bennett ◽  
◽  
J. Helen Cross ◽  
Anna E. Coughtrey ◽  
Isobel Heyman ◽  
...  
Keyword(s):  
Mental Health ◽  
Young People ◽  
Usual Care ◽  
Psychological Intervention ◽  
Mental Health Disorders ◽  
Long Term Conditions ◽  
Children And Young People ◽  
Health Disorders ◽  
Randomised Controlled

Abstract Background Mental health disorders in the context of long-term conditions in children and young people are currently overlooked and undertreated. Evidence-based psychological treatments for common childhood mental health disorders (anxiety, depression and disruptive behaviour disorders) have not been systematically evaluated in young people with epilepsy despite their high prevalence in this population. The aim of this multi-site randomised controlled trial is to determine the clinical and cost-effectiveness of adding a modular psychological intervention to usual care for the mental health disorders in comparison to assessment-enhanced usual care alone. Methods In total, 334 participants aged 3–18 years attending epilepsy services will be screened for mental health disorders with the Strengths and Difficulties Questionnaire (SDQ) and the diagnostic Development and Wellbeing Assessment (DAWBA). Those identified as having a mental health disorder and consenting to the trial will be randomised to either receive up to 22 sessions of the modular psychological intervention (MATCH-ADTC) delivered over the telephone over 6 months by non-mental health professionals in addition to usual care or to assessment-enhanced usual care alone. Outcomes will be measured at baseline, 6 months and 12 months post-randomisation. It is hypothesised that MATCH-ADTC plus usual care will be superior to assessment-enhanced usual care in improving emotional and behavioural symptoms. The primary outcome is the SDQ reported by parents at 6 months. Secondary outcomes include parent-reported mental health measures such as the Revised Children’s Anxiety and Depression Scale, quality of life measures such as the Paediatric Quality of Life Inventory and physical health measures such as the Hague Seizure Severity Scale. Outcome assessors will be blinded to group assignment. Qualitative process evaluations and a health economic evaluation will also be completed. Discussion This trial aims to determine whether a systematic and integrated approach to the identification and treatment of mental health disorders in children and young people with epilepsy is clinically and cost-effective. The findings will contribute to policies and practice with regard to addressing mental health needs in children and young people with other long-term conditions. Trial registration ISRCTN ISRCTN57823197. Registered on 25 February 2019.

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Link Type ◽  
Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

Efficacy of ‘Foundations’, a Digital Mental Health App to Improve Mental Well-Being, during COVID-19: A Proof-of-Principle Randomised Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Silvina Catuara-Solarz ◽  
Bartlomiej Skorulski ◽  
Inaki Estella ◽  
Claudia Avella-Garcia ◽  
Sarah Shepherd ◽  
...  
Keyword(s):  
Mental Health ◽  
Perceived Stress ◽  
Intervention Group ◽  
Well Being ◽  
Self Report ◽  
World Health ◽  
Randomised Control Trial ◽  
Control Group ◽  
Mental Well Being ◽  
Proof Of Principle

BACKGROUND Against a long-term trend of increasing demand, the COVID-19 pandemic has led to a global rise in common mental disorders. Now more than ever, there is an urgent need for scalable, evidence-based interventions to support mental well-being. OBJECTIVE The aim of this proof-of-principle study was to evaluate the efficacy of a mobile-based app in adults with self-reported symptoms of anxiety and stress in a randomised control trial that took place during the first wave of the COVID-19 pandemic in the UK. METHODS Adults with mild to severe anxiety and moderate to high levels of perceived stress were randomised to either the intervention or control arm. Participants in the intervention arm were given access to the app, Foundations, for the duration of the 4-week study. All participants were required to self-report a range of validated measures of mental well-being (10-item Connor-Davidson Resilience scale [CD-RISC-10]; 7-item Generalised Anxiety Disorder scale [GAD-7]; Office of National Statistics Four Subjective Well-being Questions [ONS-4]; World Health Organisation-5 Well-Being Index [WHO-5]) and sleep (Minimal Insomnia Scale [MISS]) at baseline and weeks 2 and 4; and, in addition, on perceived stress weekly (10-item Perceived Stress Score [PSS]). RESULTS 136 participants completed the study and were included in the final analysis. The intervention group (n=62) showed significant improvements compared to the control group (n=74) on measures of anxiety (GAD-7 score, delta from baseline to week 2 in the intervention group: -1.35 [SD 4.43]; control group: -0.23 [SD 3.24]; t134= 1.71 , P=.04), resilience (CD-RISC score, delta from baseline to week 2 in the intervention group: 1.79 [± SD 4.08]; control group: -0.31 [± SD 3.16]; t134 -3.37, P<.001), sleep (MISS score, delta from baseline to week 2 in the intervention group: -1.16 [± SD 2.67]; control group: -0.26 [± SD 2.29]; t134= 2.13, P=.01), and mental well-being (WHO-5 score, delta from baseline to week 2 in the intervention group: 1.53 [5.30]; control group: -0.23 [± SD 4.20]; t134= -2.16, P=.02) within 2 weeks of using Foundations, with further improvements emerging at week 4. Perceived stress was also reduced within the intervention group, although the results did not reach statistical significance relative to the control group (PSS score, delta from baseline to week 2 in the intervention group: -2.94 [± SD 6.84]; control group: -2.05 [± SD 5.34]; t134= 0.84, P=.20). CONCLUSIONS This study provides proof-of-principle that the digital mental health app, Foundations, can improve measures of mental well-being, anxiety, resilience, and sleep within 2 weeks of use, with greater effects after 4 weeks. It therefore offers potential as a scalable, cost-effective, and accessible solution to enhance mental well-being, even during times of crisis such as the COVID-19 pandemic.

scholarly journals The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change

2019 ◽  
Author(s):  
Caroline Laker ◽  
Matteo Cella ◽  
Felicity Callard ◽  
Til Wykes
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Occupational Status ◽  
Intervention Group ◽  
Direct Care ◽  
Care Staff ◽  
Control Group ◽  
Staff Perceptions ◽  
Barriers To Change ◽  
Randomised Controlled

Abstract Background Staff and service users have expressed concerns that service improvements in U.K. mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation. Method A cluster randomised controlled trial called DOORWAYS was conducted on eight inner-city U.K. acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses’ perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered. Results Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N=120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group. Conclusion Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards.

scholarly journals Equine-assisted biographical work (EABW) with individuals in the second half of life: study protocol of a multicentre randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Julia Schmidt ◽  
Andrea Wartenberg-Demand ◽  
Simon Forstmeier
Keyword(s):  
Quality Of Life ◽  
Major Depression ◽  
Phase Iii ◽  
Control Group ◽  
Equine Assisted Therapy ◽  
Health Related ◽  
Randomised Controlled ◽  
Equine Assisted ◽  
Subclinical Depression

Abstract Background Equine-assisted therapy is more often practiced with children and adolescents than with the elderly, although individuals in the second half of life could also profit from it. This group, from the age of 50, is characterised by increasing emotional, social, health-related and cognitive changes; a critical life event, such as a neurological illness or loss of a family member, can increase the likelihood of subclinical depression. Individuals who exhibit depressive symptoms not necessarily diagnosed with a major depression may suffer from relevant losses of quality of life (e.g. sleep disorders, memory disorders, feelings of guilt, hopelessness). Despite the fact that the various healthcare systems are in general more frequently used, such individuals often do not receive adequate therapy. The processing of one’s biography (reminiscence) is an elementary component of most psychotherapy approaches and has been demonstrated to treat and prevent the development of major depression. In this study, equine-assisted biographical work (EABW), a combination of equine-assisted therapy and biographical work, will be applied with individuals with subclinical depression in the second half of their life. Methods This is a multicentre, prospective, randomised, controlled and open phase III study in enrolling participants with subclinical depression. The aim of the study is to evaluate whether a preventive, equine-assisted, age-specific treatment combining elements of equine-assisted intervention with those of biographical work offers better treatment potentials in comparison to a control group with no intervention. Study participants in the intervention group will receive weekly equine-assisted biographical work over a period of 8 weeks. The primary endpoint is the change in Beck Depression Inventory-II (BDI-II) in a pre-post comparison. Secondary endpoints include other health-related questionnaires including quality of life, reminiscence functions and anxiety. Discussion The present study is the first randomised study examining the efficacy of biographical work with a horse and has the potential to establish an empirically based treatment for individuals in the second half of life and improving the symptoms of subclinical depression. Trial registration German Clinical Trials Register DRKS00017010. Registered on 01 April 2019

scholarly journals Enhancing help-seeking behaviour among men who have sex with men at risk for sexually transmitted infections: the syn.bas.in randomised controlled trial

2020 ◽  
pp. sextrans-2020-054438 ◽  
Author(s):  
Roeland Christiaan Alfons Achterbergh ◽  
Martijn S van Rooijen ◽  
Wim van den Brink ◽  
Anders Boyd ◽  
Henry John Christiaan de Vries
Keyword(s):  
Mental Health ◽  
Substance Use ◽  
Randomised Controlled Trial ◽  
Help Seeking ◽  
Controlled Trial ◽  
Risk Behaviour ◽  
Control Group ◽  
Help Seeking Behaviour ◽  
Sex With Men ◽  
Randomised Controlled

ObjectivesMen who have sex with men (MSM) are at increased risk for STIs and mental disorders. Syndemic theory holds that psychosocial issues co-occur and interact, and thus increase sexual risk behaviour. Psychosocial issue identification, referral and management might reduce risk behaviour.MethodsIn the syndemic-based intervention study, an open-label randomised controlled trial, MSM were enrolled at the STI outpatient clinic of the Public Health Service of Amsterdam. We screened participants using validated questionnaires on the following problem domains: alcohol and substance use, sexual compulsivity, anxiety, depression, attention deficit hyperactivity disorder, alexithymia, intimate partner violence and childhood sexual abuse. Individuals were randomly assigned (1:1) to receive either tailored, face-to-face feedback and help-seeking advice on mental health screening, or no feedback and no help-seeking advice. Participants were followed trimonthly for a year. The primary outcomes were self-reported and confirmed help-seeking behaviour.ResultsWe included 155 MSM: 76 in the intervention group and 79 in the control group. At inclusion, 128 participants (83.1%) scored positive in at least one problem domain. We found no significant differences in self-reported or confirmed help-seeking behaviour between the intervention and the control group: 41% vs 29% (p=0.14) and 28% vs 22% (p=0.44), respectively. There were also no differences in STI incidence and condomless anal sex acts between the two groups.ConclusionScreening showed high prevalence of problems related to mental health and substance use, while tailored feedback, advice and referral did not significantly increase help-seeking behaviour. Other interventions are needed to tackle the high burden of mental disorders among MSM.Trial registration numberNCT02859935.

scholarly journals A Pilot Randomised Controlled Trial of the Peer Tree Digital Intervention Targeting Loneliness Iin Young People: A Study Protocol

2021 ◽  
Author(s):  
Michelle H Lim ◽  
Lily Thurston ◽  
Robert Eres ◽  
Thomas L Rodebaugh ◽  
Mario Alvarez-Jimenez ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Social Anxiety ◽  
Young People ◽  
Positive Psychology ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Pilot Randomised Controlled Trial ◽  
Positive Psychology Interventions ◽  
Randomised Controlled

Abstract Background: Young people are vulnerable to experiencing problematic levels of loneliness which can lead to poor mental health outcomes. Loneliness is a malleable treatment target and preliminary evidence has shown that it can be addressed with digital platforms. Peer Tree is a strengths-based digital smartphone application aimed at reducing loneliness. The study aim is to reduce loneliness, and assess the acceptability, usability, and feasibility of Peer Tree in young people enrolled at university. Methods: This will be a pilot randomised controlled trial (RCT) comparing a strengths-based digital smartphone application (Peer Tree) with a treatment as usual (TAU) condition. Forty-two young people enrolled at university will be recruited for this pilot RCT. Participants with suicidality risk, acute psychiatric symptoms in the past month, or a current diagnosis of a mood or social anxiety disorder will be excluded. Allocation will be made on a 1:1 ratio and will occur after the initial baseline assessment. Assessments are completed at baseline, post-intervention, and at follow-up. Participants in the TAU condition complete the same three assessment sessions. The primary outcomes of the study will be self-reported loneliness as well as the acceptability, usability, feasibility and safety of Peer Tree. Depression, social anxiety, and quality of life variables will also be measured as secondary outcomes. Discussion: This trial will report the findings of implementing Peer Tree, a smartphone application aimed at reducing loneliness in university students. Findings from this trial will highlight the initial efficacy, acceptability and feasibility of using digital positive psychology interventions to reduce subthreshold mental health concerns. Findings from this trial will also describe the safety of Peer Tree as a digital tool. Results will contribute evidence for positive psychology interventions to address mental ill-health.Trial registration: Australian New Zealand Clinical Trial Registry, ACTRN12619000350123. Registered 6th March 2020

scholarly journals Protocol for the RELATE trial: a feasibility and pilot randomised controlled trial of a low-intensity group intervention for young people in care with elevated posttraumatic stress symptoms

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Rachel M. Hiller ◽  
Rebecca S. Davis ◽  
John Devaney ◽  
Sarah L. Halligan ◽  
Richard Meiser-Stedman ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Young People ◽  
Posttraumatic Stress ◽  
Group Intervention ◽  
Social Care ◽  
Controlled Trial ◽  
Good Evidence ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Introduction Young people in out-of-home care have often experienced trauma, such as direct maltreatment or witnessing violence. There is good evidence that rates of mental health difficulties are high in this group, including posttraumatic stress disorder (PTSD), a trauma-specific mental health outcome. There remains less evidence to guide how to effectively address elevated PTSD symptoms (PTSS) in these young people, particularly in ways that are feasible and scalable for stretched social-care and mental health services. Methods and analysis This protocol describes a feasibility study comprising a pilot two-arm randomised controlled trial (RCT). Participants (N = 50) will be randomised to either (a) a group-based trauma-focused programme (Teaching Recovery Techniques), delivered by mental health practitioners both online and in-person, or (b) care-as-usual. Primarily, the trial aims to explore the key feasibility and protocol acceptability questions, including rates of recruitment and retention, as well as the acceptability of the intervention (particularly the online delivery format) to participants and services. In addition, outcomes including PTSS (primary clinical outcome), depression and functioning will be assessed at baseline (pre-randomisation), post-intervention and at a 3-month follow-up. Ethics and dissemination Ethical approval has been received from the Health Research Authority (Wales REC1 Ref 20/WA/0100) and University, with further approval from the host trust and social care site. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries. Trial registration ClinicalTrials.gov, NCT04467320. Registered on 13 July 2020.

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