Dataset Information

Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Mindfulness is one of the potential alternative interventions for children with attention-deficit hyperactivity disorder (ADHD). Some evidence suggests that mindfulness is related to changes in brain regions associated with ADHD. The potential benefits of mindfulness on children with ADHD, as well as the feasibility of this intervention approach, are warranted through prior local and foreign studies. This study aims to evaluate the effect of mindfulness-based group intervention for children with ADHD and their respective parents through a robust research design.

Methods and analysis

This study will adopt a randomised controlled trial design including 140 children aged 8-12 years with ADHD together with one of their parents (n=140). These families will be randomised into intervention group (n=70) who will be offered the MYmind programme delivered by trained healthcare professionals, and an active control group (n=70) who will be offered the CBT programme. The intervention includes 8 weekly 90?min group sessions for children with ADHD (aged 8-12 years) and their respective parents. The primary and secondary outcomes will include children's attention, ADHD-related symptoms, behaviours, executive function and mindfulness levels measured by validated objective measures and parent's reported instruments. Parents' parental stress, parenting styles, ADHD related symptoms, well-being, rumination level and mindfulness levels will also be measured. Analysis is by intention to treat. The effects of intervention will be evaluated by comparing outcomes between the two arms, as well as comparing outcomes within subject through comparing measurements at baseline (T0), immediately after the 8?week intervention (T1) and at 3 (T2) and 6 (T3) months postintervention.

Ethics and dissemination

Ethics approval has been granted by the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC). Participants will be required to sign informed consent form from both parents and children. Findings will be reported in conferences and peer-reviewed publications in accordance with recommendations of Consolidated Standards of Reporting Trials.

Trial registration number

ChiCTR1800014741; Pre-results.

SUBMITTER: Chan SKC

PROVIDER: S-EPMC6252633 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Publications

Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial.

Chan Stanley Kam Chung SKC Zhang Dexing D Bögels Susan M SM Chan Christian Shaunlyn CS Lai Kelly Yee Ching KYC Lo Herman Hay Ming HHM Yip Benjamin Hon Kei BHK Lau Elsa Ngar Sze ENS Gao Tiffany Ting TT Wong Samuel Yeung Shan SYS

BMJ open 20181112 11

<h4>Introduction</h4>Mindfulness is one of the potential alternative interventions for children with attention-deficit hyperactivity disorder (ADHD). Some evidence suggests that mindfulness is related to changes in brain regions associated with ADHD. The potential benefits of mindfulness on children with ADHD, as well as the feasibility of this intervention approach, are warranted through prior local and foreign studies. This study aims to evaluate the effect of mindfulness-based group intervent ...[more]

PMID: 30420347

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Project description:BackgroundFamily mindfulness-based intervention (MBI) for child attention-deficit/hyperactivity disorder (ADHD) targets child self-control, parenting and parental mental health, but its effectiveness is still unclear.MethodsMindChamp is a pre-registered randomised controlled trial comparing an 8-week family MBI (called 'MYmind') in addition to care-as-usual (CAU) (n = 55) with CAU-only (n = 48). Children aged 8-16 years with remaining ADHD symptoms after CAU were enrolled together with a parent. Primary outcome was post-treatment parent-rated child self-control deficits (BRIEF); post hoc, Reliable Change Indexes were explored. Secondary child outcomes included ADHD symptoms (parent/teacher-rated Conners' and SWAN; teacher-rated BRIEF), other psychological symptoms (parent/teacher-rated), well-being (parent-rated) and mindfulness (self-rated). Secondary parent outcomes included self-ratings of ADHD symptoms, other psychological symptoms, well-being, self-compassion and mindful parenting. Assessments were conducted at post-treatment, 2- and 6-month follow-up.ResultsRelative to CAU-only, MBI+CAU resulted in a small, statistically non-significant post-treatment improvement on the BRIEF (intention-to-treat: d = 0.27, p = .18; per protocol: d = 0.33, p = .11). Significantly more children showed reliable post-treatment improvement following MBI+CAU versus CAU-only (32% versus 11%, p < .05, Number-Needed-to-Treat = 4.7). ADHD symptoms significantly reduced post-treatment according to parent (Conners' and SWAN) and teacher ratings (BRIEF) per protocol. Only parent-rated hyperactivity impulsivity (SWAN) remained significantly reduced at 6-month follow-up. Post-treatment group differences on other secondary child outcomes were consistently favour of MBI+CAU, but mostly non-significant; no significant differences were found at follow-ups. Regarding parent outcomes, significant post-treatment improvements were found for their own ADHD symptoms, well-being and mindful parenting. At follow-ups, some significant effects remained (ADHD symptoms, mindful parenting), some additional significant effects appeared (other psychological symptoms, self-compassion) and others disappeared/remained non-significant.ConclusionsFamily MBI+CAU did not outperform CAU-only in reducing child self-control deficits on a group level but more children reliably improved. Effects on parents were larger and more durable. When CAU for ADHD is insufficient, family MBI could be a valuable addition.

Project description:IntroductionSignificant numbers of children with attention deficit hyperactivity disorder (ADHD) display problems that cause multiple disabilities, deficits and handicaps that interfere with social relationships, development and school achievement. They may have multiple problems, which strain family dynamics and influence the child's treatment. Parent activation, described as parents' knowledge, skills and confidence in dealing with their child's health and healthcare, has been shown to be an important factor in improving health outcomes. Research suggests that parents need edification to learn skills crucial to the treatment and management of their children's healthcare. Promoting positive parenting techniques may reduce negative parenting factors in families. This study aims to assess the acceptability, feasibility and estimated sample size of a randomised controlled trial (RCT) comparing an ADHD peer co-led educational programme added to treatment as usual (TAU).Methods and analysisUsing a randomised waitlist controlled trial, parents of children aged 6-12 years newly diagnosed with ADHD, and referred to a child mental health outpatient clinic in Mid-Norway, will receive TAU concomitant with a peer co-facilitated parental engagement educational programme (n=25). Parents in the control group will receive TAU, and the educational programme treatment within a waitlist period of 3-6 months (n=25). Parent activation, satisfaction, well-being, quality of life and treatment adherence, will be assessed at baseline (T0), 2 weeks (T1) pre-post intervention (T2, T3) and at 3 months follow-up (T4). Shared decision making, parents preferred role in health-related decisions and involvement, parent-reported symptoms of ADHD and child's overall level of functioning will be assessed at T0 and T4. Such data will be used to calculate the required sample size for a full-scale RCT.Ethics and disseminationApproval was obtained from the Regional Committee for Medicine and Health Research Ethics in Mid-Norway (ref: 2018/1196). The findings of this study are expected to provide valuable knowledge about how to optimise family education and management of ADHD and will be disseminated through presentations at conferences and publication in peer-reviewed journals.Trial registration numberNCT04010851.

Project description:BackgroundSelf-control in childhood has been linked to long-term and cascading effects on health, academic, criminality, wealth and parenting outcomes. Hence it is important to target self-control deficits early in life. Self-control deficits are a hallmark of Attention Deficit/Hyperactivity Disorder (ADHD). Even after receiving care-as-usual (CAU) for ADHD, impaired self-control often remains. Pharmacotherapy can be hampered by side-effects, low adherence and short-term effectiveness. Other limitations of CAU are decreased effectiveness when parents have ADHD and little effect on parental well-being. Mindfulness-Based Interventions (MBIs) are an emerging non-pharmacological approach with potential to improve self-control and well-being in both children and parents. However, there is a lack of sufficiently powered randomised controlled trials (RCTs) to establish their effects in families with ADHD. This study protocol describes an RCT to investigate the effectiveness of a family MBI as an add-on to CAU in treatment of youth with ADHD, and is described in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT).Methods/designAn RCT will be conducted in N = 100 children (aged 8-16 years) with ADHD and their parents. The experimental condition will consist of a family MBI (MYmind): 8-week group-based MBI for youth combined with parallel group-based Mindful Parenting for their parents, as an add-on to CAU. The control condition will consist of CAU-only. Assessments will take place at baseline, end of treatment (3 months later), 2 and 6 months' follow-up. Primary outcome measure will be an ecologically valid assessment of child self-control with the parent-rated Behaviour Rating Inventory of Executive Function (BRIEF). Secondary child outcome measures will be teacher-rated BRIEF, computerised self-control tasks and questionnaires on psychological symptoms (e.g. ADHD, symptoms of autism), well-being and mindfulness. For parental outcomes, secondary measures will be self-rated BRIEF, computerised self-control tasks and questionnaires on psychological symptoms, well-being and mindful parenting.DiscussionThe proposed RCT will take account of methodological limitations of previous studies on MBIs in child ADHD populations. The current study will provide valuable information on family MBI as a potential effective intervention in targeting self-control deficits for youth with ADHD and their parents.Trial registrationClinicalTrials.gov NCT03220308 . Retrospectively registered 18 July 2017.

Project description:IntroductionCurrent interventions for children with attention-deficit/hyperactivity disorder (ADHD) are primarily medication, behavioural therapy and parent training. However, research suggests dietary manipulations may provide therapeutic benefit for some. There is accumulating evidence that the gut microbiome may be atypical in ADHD, and therefore, manipulating gut bacteria in such individuals may help alleviate some of the symptoms of this condition. The aim of this study is to explore the effects of supplementation with kefir (a fermented dairy drink) on ADHD symptomatology, sleep, attention and the gut microbiome in children diagnosed with ADHD.Methods and analysisA 6-week randomised, double-blind, placebo-controlled trial in 70 children aged 8-13 years diagnosed with ADHD. Participants will be recruited throughout the UK, through support groups, community groups, schools, social media and word of mouth. Children will be randomised to consume daily either dairy kefir or a placebo dairy drink for 6 weeks. The primary outcome, ADHD symptomatology, will be measured by The Strengths and Weakness of ADHD-symptoms and Normal-behaviour scale. Secondary outcomes will include gut microbiota composition (using shotgun metagenomic microbiome sequencing), gut symptomatology (The Gastrointestinal Severity Index questionnaire), sleep (using 7-day actigraphy recordings, The Child's Sleep Habits Questionnaire and Sleep Self Report questionnaire), inattention and impulsivity (with a computerised Go/NoGo test). Assessments will be conducted prior to the intervention and at the end of the intervention. Interaction between time (preintervention/postintervention) and group (probiotic/placebo) is to be analysed using a Mixed Model Analysis of Variances.Ethics and disseminationEthical approval for the study was granted by St Mary's University Ethics Committee. Results will be disseminated through peer-reviewed publications, presentations to the scientific community and support groups.Trial registration numberNCT05155696.

Project description:BackgroundChildren referred for attention-deficit/hyperactivity disorder (ADHD) often present with a broader pattern of conduct problems including oppositionality and defiance. This combination can be extremely stressful to parents, lower parents' self-esteem and negatively impact family life. The National Institute for Health and Care Excellence (NICE) recommends that families receive support as soon as possible after their referral. However, as clinical services are overstretched, and traditional in-person parenting intervention programmes are expensive, families often must wait times a long time prior to receiving this vital input. To address this, we have created a digital parenting programme called STEPS. It is delivered as a mobile phone app providing a set of tools and resources that can be easily accessed at parents' convenience. This study aims to evaluate the clinical and cost-effectiveness of STEPS in supporting parents of children with high levels of hyperactivity/impulsivity, inattention and conduct problems, who are waiting to be assessed by specialist children's clinical services.MethodsOnline Parent Training for The Initial Management of ADHD referrals (OPTIMA) is a two-arm superiority parallel randomised controlled trial with an internal pilot study. We aim to recruit 352 parents and their children, who have been accepted onto a waitlist in Child and Adolescent Mental Health Services or similar child health services. Parents who consent will be randomised 1:1 to either the STEPS or wait-as-usual (WAU) group. The trial will be conducted remotely (online and telephone) with measures taken at baseline and 3, 6, 9 and 12 months post-randomisation. The primary objective is to evaluate whether STEPS reduces the severity of children's oppositional and defiant behaviour, as rated by parents, measured at 3 months post-randomisation compared to WAU.DiscussionDigital solutions, such as mobile phone apps, have potential for delivering psychological support for parents of children with clinical-level needs in a timely and inexpensive manner. This trial will provide data on the clinical and cost-effectiveness of the STEPS app, which could support the implementation of this scalable parenting intervention programme into standard clinical care and, ultimately, improve the outcomes for families of children referred to specialist child and adolescent health services.Trial registrationISRCTN 16523503. Prospectively registered on 18 November 2021. https://www.isrctn.com/ISRCTN16523503.

Project description:INTRODUCTION:Incidence of autistic traits, mental health problems, stress and poor coping is high among family members of children with autism. These problems are coupled with challenging behaviour among children with autism. Current treatment for these families is disjointed and costly. The need for whole family support is supported by the National Institute for Health and Care Excellence recommendations, developments regarding children's service provision, research and requests by families of children with autism. Despite evidence that family therapies can provide benefits to these families, efficacy has not been subject to a randomised controlled trial. Systemic Autism-related Family Enabling (SAFE) is a new family therapy intervention designed specifically for families of children with autism. We aim to establish the feasibility of running a fully powered randomised controlled trial to evaluate SAFE. METHODS AND ANALYSIS:Families of children with autism aged 3-16 years will be invited to participate. Consenting participants will be randomised 2:1 to either SAFE+support as usual or support as usual alone. The proposed primary outcome measure for the main trial will be the Systemic CORE 15. Participants will also complete proposed secondary outcome measures, indexing changes in child behaviour, child-parent attachment, anxiety and depression. Generic health economic outcome measures (EuroQol 5 dimensions and Child Health Utility 9 Dimensions) will also provide data on the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline and 32 weeks post-allocation. Data on ability to identify, recruit, randomise, retain and collect data from families, acceptability of outcome measures, adherence of therapists and families to the intervention, appropriateness of resource use questionnaires and effectiveness of training will be collected for feasibility analysis. Qualitative data will also explore acceptability of SAFE and reasons for declining and withdrawing from the study. ETHICS AND DISSEMINATION:The current trial protocol received ethical approval from the South West-Exeter Research Ethics Committee (Ref: 17/SW/0192). The findings of the trial will be disseminated in collaboration with our Family Consultation Group and other partners. Findings will be shared locally, nationally and internationally through events, conferences and published papers. TRIAL REGISTRATION NUMBER:ISCTRN83964946 (Pre-results) IRAS 213527.

Project description:IntroductionAdolescents with attention deficit hyperactivity disorder (ADHD) experience a more disrupted sleep and more sleep problems compared with typically developing adolescents. This is particularly concerning, because disrupted sleep is related to worsened clinical, neurocognitive and functional outcomes and leads to increased ADHD symptom impairment. Due to the specific difficulties adolescents with ADHD experience, a tailored sleep treatment is needed. Therefore, our lab developed a cognitive behavioural treatment-Sleep IntervEntion as Sympom Treatment for ADHD (SIESTA)-that integrates sleep training with motivational interviewing, and planning/organisational skills training with the aim of improving sleep problems in adolescents with ADHD.Methods and analysisA randomised, controlled, investigator-blinded monocentre trial is used to test whether SIESTA in combination with treatment as usual (TAU) for ADHD results in greater improvement in sleep problems than TAU only. Adolescents (aged 13-17 years) with ADHD and sleep problems are included. They complete measurements before treatment (pre-test), approximately 7 weeks after the pre-test (post-test), and approximately 3 months after the post-test (follow-up). The assessment includes questionnaires filled out by adolescents, parents and teachers. Additionally, sleep is assessed by actigraphy and sleep diaries at all time-points. Primary outcomes include objectively and subjectively measured sleep architecture (specified as total sleep time, sleep onset latency, sleep efficiency and number of awakenings), subjectively measured sleep problems and sleep hygiene. Secondary outcomes include ADHD symptoms, comorbidities and functional outcomes. To analyse the data, a linear mixed effects model will be used with an intent-to-treat approach.Ethics and disseminationThe study activities, informed consent and assent forms have been approved by the Ethical Committee Research UZ/KU Leuven (study ID S64197). If proven effective, the intervention will be implemented throughout Flanders. Therefore, an advisory board consisting of societal partners in healthcare is appointed at the start of the project, giving advice throughout the project and assistance with implementation afterwards.Trial registration numberNCT04723719.

Project description:IntroductionResidency is a stressful phase associated with high prevalence of mental distress. Besides impaired personal health, mental distress in residents has an impact on the quality of patient care and produces economic costs. Therefore, there is demand for interventions that improve resident physicians' mental health. The aim of the present study is to examine the effects of a mindfulness-based intervention that has been tailored to residents' needs. Specifically, mindfulness has been supplemented by a focus on the concept of Muße.Methods and analysisThis study applies a randomised controlled multimethod design. Residents assigned to the intervention group will participate in an 8-week mindfulness course followed by a 4-month maintenance phase, whereas residents assigned to the control group will read text-based information about mindfulness on a weekly basis for the duration of 8 weeks. The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents' self-care as well as on building empathic relationships. Participants will be assessed before, directly after the intervention, after the maintenance phase as well as at follow-up 6 months after the intervention group completes the intervention. Assessments will consist of self-report measures, physiological data, qualitative interviews, third-party reports as well as implicit and projective measures and will focus on both psychopathology and salutogenesis. The primary outcome will be burnout. Data will be analysed using linear mixed modelling.Ethics and disseminationThe study was approved by the ethics committee of the Medical Center - University of Freiburg and is funded by the German Research Foundation as part of the interdisciplinary Collaborative Research Center 'SFB Muße 1015'. The results of this study will be published in scientific journals and disseminated through the study's website, and conferences.Trial registration numberDRKS00014015.

Dataset Information

Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial.

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