MindMate2U: Development and feasibility study of a co-designed school-based mHealth intervention for symptomatic adolescents (Preprint)

BACKGROUND Early intervention can reduce the risk of mental health disorder in young people. Given the burden on services, schools often provide frontline support, but with few resources. School-hosted mHealth is a novel option which could meet young people’s needs for privacy in mental health intervention and schools’ need for evidence-based resources. OBJECTIVE We aimed to co-design and feasibility test a self-help, school hosted, digital intervention for symptomatic adolescents in UK high schools. METHODS Extensive co-design processes integrated user and stakeholder design and implementation preferences with evidence, theory and treatment guidelines with. We conducted co-design workshops (n=14) and iterative content development reviews (n=40) with youth, parents/carers, teachers, mental health professionals and software engineers. Co-design determined the intervention aim, content, user features, implementation and evaluation protocol, and led to the production of a web-app 'MindMate2U' as well as to a low-intensity parent component ‘Partner2U’ (email psychoeducation and support). Feasibility was tested in school-selected year groups in four UK high schools where young people opted in to use MindMate2U. We specified rules for progression to an effectiveness randomised controlled trial, tested two candidate primary outcome measures (SDQ and WEMWBS) and conducted an exploratory cost-effectiveness analysis RESULTS MindMate2U is an evidence-based, six-week, self-help program targeting risk and protective factors for mental health with content released weekly to a young person’s smartphone. It met high standards of clinical safety, privacy needs and user testing before trial. Four large UK urban secondary schools opted into the study and committed to low intensity teacher training on MindMate2U, creating individual web-app accounts for participating young people, a teacher being ‘on standby’ for users and assessing any post-intervention needs. Thirty-one adolescents (15-17y) opted to use MindMate2U. Most scored in sub-clinical or clinical ranges. User ratings (n=19) and post-intervention interviews (n=6) showed acceptability of the resource. We met our recruitment, retention and pre-post measure completion targets and identified the SDQ as the most sensitive outcome measure. Young people designed release of the parent component to be under their control. Only one young person opted for this. Improvements and design parameters for an effectiveness trial were identified. CONCLUSIONS This study established the feasibility of a co-designed mental health app as a low-burden, school-hosted resource for symptomatic young people and opens up new possibilities for the integration of mHealth in schools. There is scope to consider how MindMate2U could operate within schools as an adjunct to school counselling. Support via schools to parents of symptomatic young people may need to be universal rather than targeted to protect young people’s needs for autonomy and privacy. Following some development of MM2U, a subsequent phase 2 randomized controlled trial is warranted to test its effectiveness in reducing clinical risk among symptomatic young people.

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WHO Parents Skills Training (PST) programme for children with developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for effectiveness implementation hybrid cluster randomized controlled trial

Global Mental Health ◽

10.1017/gmh.2017.7 ◽

2017 ◽

Vol 4 ◽

Cited By ~ 11

Author(s):

S. U. Hamdani ◽

P. Akhtar ◽

Zill-e-Huma ◽

H. Nazir ◽

F. A. Minhas ◽

...

Keyword(s):

Mental Health ◽

Developmental Disorders ◽

Controlled Trial ◽

Public Mental Health ◽

Skills Training ◽

Well Being ◽

Evidence Based ◽

Post Intervention ◽

Hybrid Cluster ◽

Rural Pakistan

Background.Development disorders and delays are recognised as a public health priority and included in the WHO mental health gap action programme (mhGAP). Parents Skills Training (PST) is recommended as a key intervention for such conditions under the WHO mhGAP intervention guide. However, sustainable and scalable delivery of such evidence based interventions remains a challenge. This study aims to evaluate the effectiveness and scaled-up implementation of locally adapted WHO PST programme delivered by family volunteers in rural Pakistan.Methods.The study is a two arm single-blind effectiveness implementation-hybrid cluster randomised controlled trial. WHO PST programme will be delivered by ‘family volunteers’ to the caregivers of children with developmental disorders and delays in community-based settings. The intervention consists of the WHO PST along with the WHO mhGAP intervention for developmental disorders adapted for delivery using the android application on a tablet device. A total of 540 parent-child dyads will be recruited from 30 clusters. The primary outcome is child's functioning, measured by WHO Disability Assessment Schedule – child version (WHODAS-Child) at 6 months post intervention. Secondary outcomes include children's social communication and joint engagement with their caregiver, social emotional well-being, parental health related quality of life, family empowerment and stigmatizing experiences. Mixed method will be used to collect data on implementation outcomes. Trial has been retrospectively registered at ClinicalTrials.gov (NCT02792894).Discussion.This study addresses implementation challenges in the real world by incorporating evidence-based intervention strategies with social, technological and business innovations. If proven effective, the study will contribute to scaled-up implementation of evidence-based packages for public mental health in low resource settings.Trial registration.Registered with ClinicalTrials.gov as Family Networks (FaNs) for Children with Developmental Disorders and Delays. Identifier: NCT02792894 Registered on 6 July 2016.

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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

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00936-7 ◽

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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Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04781-6 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Krister W. Fjermestad ◽

Wendy K. Silverman ◽

Torun M. Vatne

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Family Communication ◽

Neurodevelopmental Disorders ◽

Group Intervention ◽

Controlled Trial ◽

Evidence Based ◽

Post Intervention ◽

Randomized Controlled ◽

The Impact

Abstract Background Siblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly described parent components and none are considered evidence-based. Methods We are conducting a randomized controlled trial comparing a five-session manual-based group intervention for siblings (aged 8 to 16 years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT. The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone. The intervention aims at improving parent-child communication and covers themes such as siblings’ understanding of the neurodevelopmental disorder, siblings’ emotions, and perceived family challenges. Participants are recruited through municipal and specialist health centers across Norway. The primary outcome is sibling mental health. Quality of life and family communication are secondary outcomes. Participants are block-randomized to the intervention or 12-week waitlist in groups of six. Measures are collected electronically at pre- and post-intervention/waitlist, as well as 3, 6, and 12 months post-intervention. The main effect to be examined is the difference between the intervention and waitlist at 12 weeks post. All outcomes will also be examined using growth curve analyses. We plan to include 288 siblings and their parents by the end of 2022. Discussion SIBS-RCT represents a major contribution to the research and practice field towards establishing an evidence-based intervention for siblings. In the event that intervention and waitlist are no different, the impact of SIBS-RCT is still substantial in that we will aim to identify participant subgroups that show positive response and effective components of the SIBS manual by examining group leader adherence as an outcome predictor. This will allow us to continue to re-engineer the SIBS manual iteratively to improve outcomes, and avoid the promotion of a less-than-optimal intervention. Trial registration ClinicalTrials.gov NCT04056884. Registered in August 2019

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A pilot practice-based outcomes evaluation of low-intensity cognitive behavioural interventions delivered by postgraduate trainees to children and young people with mild to moderate anxiety or low mood: an efficient way forward in mental health care?

The Cognitive Behaviour Therapist ◽

10.1017/s1754470x21000301 ◽

2021 ◽

Vol 14 ◽

Author(s):

Gavin Lockhart ◽

Christina Jones ◽

Victoria Sopp

Keyword(s):

Mental Health ◽

Young People ◽

Evidence Base ◽

Anxiety And Depression ◽

Graduate Level ◽

Post Intervention ◽

Children And Young People ◽

Behavioural Interventions ◽

Low Intensity ◽

Cognitive Behavioural

Abstract Anxiety and depression affect a significant number of children and young people (CYP) and can have a far reaching and long-lasting impact. Cognitive behavioural (CB) interventions can be effective for treating anxiety and depression in CYP but are difficult to access. Recent government policy in England seeks to train a non-traditional graduate workforce to deliver a range of CB interventions for mild to moderate anxiety and depression to CYP, in community settings. This practice-based evaluation aimed to estimate the effectiveness of CB interventions delivered by postgraduate trainees undertaking training in a range of CB interventions for mild to moderate anxiety and depression whilst on placement in schools or community Child and Adolescent Mental Health Services (CAMHS). Self- and parent-reported routine outcome measures (ROMS) were completed pre- and post-intervention, including measures of symptom severity, symptom impact and goal achievement. Significant improvements were demonstrated across all self and parent-reported measures post-intervention, with mean scores falling firmly in the non-clinical range, a significant reduction in the proportion of CYP in the clinical range on measures, and predominantly medium to large effect sizes. Results are promising in terms of the capacity to train a graduate workforce to deliver a range of low-intensity CB interventions to CYP experiencing mild to moderate depression or anxiety-based difficulties in either CAMHS or school settings, increasing capacity across the system. The current practice-based evaluation also supports the potential effectiveness of current training models/programmes. Further research is needed in terms of long-term outcomes and to compare outcomes between settings, interventions, and demographic groups. Key learning aims (1) To understand the potential prevalence rates of mental health difficulties in children and young people in England, and their wider impact. (2) Critical awareness of the evidence base for cognitive and behavioural interventions for depression and anxiety in children and young people. (3) Awareness of gaps in access to evidence-based psychological interventions for children and young people in England. (4) Knowledge of emerging graduate-level low-intensity psychological practitioner roles in England. (5) Awareness of the emerging evidence base for the estimated effectiveness of low-intensity cognitive and behavioural interventions delivered to children and young people by graduate-level practitioners in schools and community mental health settings.

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Supported online cognitive behavioural therapy for bulimia nervosa: a study protocol of a randomised controlled trial

Journal of Eating Disorders ◽

10.1186/s40337-021-00482-w ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Sarah Barakat ◽

Stephen Touyz ◽

Danielle Maloney ◽

Janice Russell ◽

Phillipa Hay ◽

...

Keyword(s):

Mental Health ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Bulimia Nervosa ◽

Controlled Trial ◽

Evidence Based ◽

Face To Face ◽

Self Help ◽

Randomised Controlled ◽

Clinician Support

Abstract Background Despite the availability of effective treatments for bulimia nervosa (BN), a number of barriers to accessibility exist. Examples include access to trained clinicians, the expense of treatment, geographical limitations, and personal limitations such as stigma regarding help seeking. Self-help interventions, delivered via a digital platform, have the potential to overcome treatment gaps by providing patients with standardised, evidence-based treatments that are easily accessible, cost-effective, and require minimal clinician support. Equally, it is important to examine the shortcomings of digital interventions when compared to traditional to face-to-face delivery (e.g., high dropout rates) in order to maximise the therapeutic effectiveness of online, self-help interventions. Methods A three-arm, multisite randomised controlled trial will be conducted in Australia examining the effectiveness and cost-effectiveness of a newly developed online self-help intervention, Binge Eating eTherapy (BEeT), in a sample of patients with full or sub-threshold BN. The BEeT program consists of 10, multimedia sessions delivering the core components of cognitive behaviour therapy. Eligible participants will be randomised to one of three groups: independent completion of BEeT as a purely self-help program, completion of BEeT alongside clinician support (in the form of weekly telemedicine sessions), or waitlist control. Assessments will take place at baseline, weekly, post-intervention, and three-month follow up. The primary outcome is frequency of objective binge episodes. Secondary outcomes include frequency of other core eating disorder behavioural symptoms and beliefs, psychological distress, and quality of life. Statistical analyses will examine treatment effectiveness, feasibility, acceptability and cost effectiveness. Discussion There is limited capacity within the mental health workforce in Australia to meet the demand of people seeking treatment for eating disorders. This imbalance has only worsened following outbreak of the COVID-19 pandemic. Further research is required into innovative digital modes of treatment delivery with the capacity to service mental health needs in an accessible and affordable manner. Self-help programs may also appeal to individuals who are more reluctant to engage in traditional face-to-face treatment formats. This study will provide rigorous evidence on how to diversify treatment options for individuals with BN, ensuring more people with the illness can access evidence-based treatment. The study has been registered with the Australia New Zealand Clinical Trials Registry (ANZCTR Registration Number: ACTRN12619000123145p). Registered 22 January 2019, https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619000123145.

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Brief Behavioural Activation (Brief BA) for Adolescent Depression: A Pilot Study

Behavioural and Cognitive Psychotherapy ◽

10.1017/s1352465817000443 ◽

2017 ◽

Vol 46 (2) ◽

pp. 182-194 ◽

Cited By ~ 8

Author(s):

Laura Pass ◽

Carl W. Lejuez ◽

Shirley Reynolds

Keyword(s):

Mental Health ◽

Pilot Study ◽

Young People ◽

Adolescent Depression ◽

Psychological Intervention ◽

Clinical Effectiveness ◽

Evidence Based ◽

Behavioural Activation ◽

Evidence Based Treatments ◽

The Uk

Background: Depression in adolescence is a common and serious mental health problem. In the UK, access to evidence-based psychological treatments is limited, and training and employing therapists to deliver these is expensive. Brief behavioural activation for the treatment of depression (BATD) has great potential for use with adolescents and to be delivered by a range of healthcare professionals, but there is limited empirical investigation with this group. Aims: To adapt BATD for depressed adolescents (Brief BA) and conduct a pilot study to assess feasibility, acceptability and clinical effectiveness. Method: Twenty depressed adolescents referred to the local NHS Child and Adolescent Mental Health service (CAMHs) were offered eight sessions of Brief BA followed by a review around one month later. Self- and parent-reported routine outcome measures (ROMs) were collected at every session. Results: Nineteen of the 20 young people fully engaged with the treatment and all reported finding some aspect of Brief BA helpful. Thirteen (65%) required no further psychological intervention following Brief BA, and both young people and parents reported high levels of acceptability and satisfaction with the approach. The pre–post effect size of Brief BA treatment was large. Conclusions: Brief BA is a promising innovation in the treatment of adolescent depression. This approach requires further evaluation to establish effectiveness and cost effectiveness compared with existing evidence-based treatments for adolescent depression. Other questions concern the effectiveness of delivery in other settings and when delivered by a range of professionals.

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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 ◽

10.1136/bmjopen-2020-045235 ◽

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.

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Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-050661 ◽

2021 ◽

Vol 11 (6) ◽

pp. e050661

Author(s):

Håvard Kallestad ◽

Simen Saksvik ◽

Øystein Vedaa ◽

Knut Langsrud ◽

Gunnar Morken ◽

...

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Patient Education ◽

Cognitive Behavioural Therapy ◽

Controlled Trial ◽

Behavioural Therapy ◽

Group Differences ◽

Post Intervention ◽

Cognitive Behavioural ◽

Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

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Mixed methods pilot evaluation of interpersonal psychotherapy for body image for adolescents

Clinical Child Psychology and Psychiatry ◽

10.1177/1359104520963371 ◽

2020 ◽

pp. 135910452096337

Author(s):

Fiona Duffy ◽

Helen Sharpe ◽

Emily Beveridge ◽

Kate Osborne ◽

Cathy Richards

Keyword(s):

Body Image ◽

Young People ◽

Body Dissatisfaction ◽

Clinical Outcomes ◽

Group Intervention ◽

Treatment Satisfaction ◽

Controlled Trial ◽

Interpersonal Psychotherapy ◽

Post Intervention ◽

Randomised Controlled

Body dissatisfaction is common in adolescence and associated with poor outcomes. The aim of this mixed method pilot evaluation was to determine acceptability, feasibility and preliminary efficacy of Interpersonal Psychotherapy for Body Image (IPT-BI), a school-based group intervention for young people with high levels of body dissatisfaction. Eighteen participants (11–13 years, 78% female) took part in two IPT-BI groups ( n = 10; n = 8). Feasibility was measured by recruitment and attrition rates; acceptability using a treatment satisfaction questionnaire and focus groups; and clinical outcomes at baseline, each session and post intervention. The majority of young people (72%, n = 18/25) who were referred or expressed interest went on to take part. Average session attendance was 100% and 89%. Participants expressed high levels of treatment satisfaction with 94% ( n = 16/17) rating IPT-BI as ‘quite helpful’ or ‘very helpful’ and 94% ( n = 16/17) stating they would recommend it to others. Preliminary exploration of efficacy showed significant improvements in body image and significant reductions in interpersonal difficulties and appearance-based conversations. Young people valued specific IPT-BI skills (role play, communication strategies), alongside generic therapeutic factors (therapeutic alliance, group cohesion). IPT-BI is feasible and acceptable with promising provisional clinical outcomes indicating the need for a fully powered randomised controlled trial.

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Telephone-guided self-help for mental health difficulties in neurological conditions: a randomised pilot trial

Archives of Disease in Childhood ◽

10.1136/archdischild-2019-318577 ◽

2021 ◽

pp. archdischild-2019-318577

Author(s):

Sophie D Bennett ◽

Isobel Heyman ◽

Anna E Coughtrey ◽

Sophia Varadkar ◽

Terence Stephenson ◽

...

Keyword(s):

Mental Health ◽

Young People ◽

Primary Outcome ◽

Outcome Measure ◽

Mental Health Problems ◽

Pilot Trial ◽

Primary Outcome Measure ◽

Self Help ◽

Mental Health Difficulties ◽

Neurological Conditions

ObjectiveThis study aimed to conduct a randomised pilot trial to assess the feasibility of a randomised controlled trial (RCT) to investigate the effect of telephone-guided self-help for the treatment of mental health difficulties in children with neurological conditions.DesignPreliminary RCT. The primary outcome measure was the Strengths and Difficulties Questionnaire.SettingNeurology clinics in a national tertiary paediatric hospital.PatientsYoung people attending neurology clinics who met criteria for mental health difficulties according to the Development and Wellbeing Assessment.Interventions12 weeks of telephone-guided self-help based on a modular approach to psychological therapy for children delivered to children and/or their parents (n=17; eight males; mean age 12.04 years, SD=3.34) or a waiting list for telephone-guided self-help with no additional intervention over 12 weeks (n=17; nine males; mean age 10.53 years, SD=3.14).Results124 participants completed the DAWBA, and 34 children and young people were entered into the trial. 65% of those randomised to the intervention arm completed the full intervention, and the intervention was acceptable to those completing it. However, there were significant problems related to lack of data completion (38% data loss for primary outcome measure), choice of control comparator and outcome measures. Due to significant loss of data at follow-up, the effect size findings are considered unreliable.ConclusionsFurther feasibility work should be conducted to improve data completeness before progression to a definitive trial of guided self-help for mental health problems in children with neurological conditions can be recommended.Trial registration numberISRCTN21184717.

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