Dataset Information

Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol.

ABSTRACT: Introduction: Significant 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 analysis: Using 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 dissemination: Approval 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 number: NCT04010851.

SUBMITTER: Mundal I

PROVIDER: S-EPMC7713204 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol.

Mundal Ingunn I Gråwe Rolf W RW Hafstad Hege H De Las Cuevas Carlos C Lara-Cabrera Mariela Loreto ML

BMJ open 20201202 12

<h4>Introduction</h4>Significant 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 t ...[more]

PMID: 33268416

Similar Datasets

Project description:BackgroundPatients play a central role in nursing preceptorship relationships, a professional educational relationship between a staff nurse and student nurse that is grounded in providing patient care. Yet the patient experiences and perspectives are largely uncaptured in the literature or represented in current preceptorship education programmes. Furthermore, the lack of student, staff nurse & patient involvement in the design of preceptorship education programmes has been noted.ObjectiveTo use a co-design process to develop an innovative educational programme for developing interpersonal and communication skills among nurses who act as preceptors. We sought to (a) clarify experiences and events from all three members involved in a preceptorship relationship (student nurse, preceptor, and patient (SPP) in order to develop a shared understanding of nursing preceptorship relationships and (b) identify the key informational and educational needs recommended by SPP for the educational programme.MethodsUsing the principles and the iterative process of Experienced Based Co Design (EBCD), data was collected from qualitative interviews and used to inform a series of co-design workshops and the co-production of the new educational programme.ResultsTwenty-six individuals, including undergraduate student nurses, staff nurses, patients, and a team of nursing, educational and educational technologist experts, contributed to developing a blended learning preceptorship educational programme that consists of three core elements (1) six online reusable learning objects, (2) two role play simulations and (3) a virtual reality storytelling simulated experience.ConclusionsThe EBCD process ensured that the educational programme was developed to meet SPP viewpoints associated with fostering positive interpersonal relationships in a nursing preceptorship. EBCD is a valuable framework for developing human-centred educational resources that combine experiential knowledge (experiences) and scientific knowledge (literature-based knowledge). It facilitated the identification and the development of Interpersonal and Communications skills (IP & C skills) training required within a nursing preceptorship relationship, creating an authentic and memorable learning programme. The structure of EBCD harnesses SPP involvement throughout the research and development process, ensuring transparency and continuity of message, scope, and outcomes.

Project description:Early intervention for childhood behavioural problems may help improve health and educational outcomes in affected children and reduce the likelihood of developing additional difficulties. The National Institute for Health and Clinical Excellence guidelines for attention deficit/hyperactivity disorder (ADHD), a common childhood behavioural disorder, recommend a stepped care approach for the identification and management of these problems. Parents of children with high levels of hyperactivity and inattention may benefit from intervention programmes involving behavioural management and educational approaches. Such interventions may be further enhanced by providing training and feedback to teachers about the strategies discussed with parents. In relation to children with high levels of hyperactivity, impulsiveness and inattention, we aim to test the feasibility and effectiveness of a parenting programme (with and without an accompanying teacher session) in primary schools. This clustered (at the level of school) randomised controlled trial (RCT) focuses on children in their first four school years (ages 4-8 years) in the East Midlands area of England. Parents will complete a screening measure, the Strengths and Difficulties Questionnaire, to identify children with high levels of hyperactivity/inattention. Three approaches to reducing hyperactivity and attention problems will be compared: a group programme for parents (parent-only intervention); group programme for parents combined with feedback to teachers (combined intervention); and waiting list control (no intervention). Differences between arms on the short version of Conners' Parent and Teacher Rating Scales Revised will be compared and also used to inform the sample size required for a future definitive cluster RCT. A preliminary cost-effectiveness analysis will also be conducted. The outcomes of this study will inform policy makers about the feasibility, acceptability and effectiveness of delivering targeted behavioural interventions within a school setting. The study has received ethical approval from the University of Nottingham Medical School Ethics Committee. ISRCTN87634685.

Project description:ObjectivesDetermine the safety, feasibility and initial efficacy of a multicomponent telerehabilitation programme for COVID-19 survivors.DesignPilot randomised feasibility study.SettingIn-home telerehabilitation.Participants44 participants (21 female, mean age 52 years) discharged home following hospitalisation with COVID-19 (with and without intensive care unit (ICU) stay).InterventionsParticipants were block randomised 2:1 to receive 12 individual biobehaviourally informed, app-facilitated, multicomponent telerehabilitation sessions with a licenced physical therapist (n=29) or to a control group (n=15) consisting of education on exercise and COVID-19 recovery trajectory, physical activity and vitals monitoring, and weekly check-ins with study staff. Interventions were 100% remote and occurred over 12 weeks.Primary and secondary outcome measuresThe primary outcome was feasibility, including safety and session adherence. Secondary outcomes included preliminary efficacy outcomes including tests of function and balance; patient-reported outcome measures; a cognitive assessment; and average daily step count. The 30 s chair stand test was the main secondary (efficacy) outcome.ResultsNo adverse events (AEs) occurred during testing or in telerehabilitation sessions; 38% (11/29) of the intervention group compared with 60% (9/15) of the control group experienced an AE (p=0.21), most of which were minor, over the course of the 12-week study. 27 of 29 participants (93%; 95% CI 77% to 99%) receiving the intervention attended ≥75% of sessions. Both groups demonstrated clinically meaningful improvement in secondary outcomes with no statistically significant differences between groups.ConclusionFully remote telerehabilitation was safe, feasible, had high adherence for COVID-19 recovery, and may apply to other medically complex patients including those with barriers to access care. This pilot study was designed to evaluate feasibility; further efficacy evaluation is needed.Trial registration numberNCT04663945.

Project description:BackgroundAs suggested by the World Health Organization, breastfeeding peer support is being introduced worldwide to support women's breastfeeding needs. Evidence has shown that when such support is offered to women, the duration and exclusivity of breastfeeding is increased. We developed an innovative home-based intervention to sustain exclusive breastfeeding in Hong Kong. However, potential barriers must be addressed before a full randomised controlled trial (RCT) is conducted. The aim of this study was to determine the feasibility of a breastfeeding support programme with home-based visits from peer supporters over a six month period among postpartum Chinese women in Hong Kong.MethodsWe conducted a feasibility and pilot randomised controlled trial. Twenty primiparous women intending to breastfeed their healthy term singleton infant were recruited from a hospital in Kowloon, Hong Kong between February and March 2019. Participants were randomly allocated to the intervention or control group. Participants in the intervention group received five home-based visits with a peer supporter over a six month period, as well as standard care, whereas participants in the control group received standard care only. We assessed feasibility, compliance, and acceptability of the breastfeeding peer support programme. Other outcomes assessed were breastfeeding self-efficacy, duration, and exclusivity.ResultsIt was feasible to recruit and train existing peer supporters, and peer supporters were able to deliver the intervention, which was acceptable to women, but rates of stopping the intervention and loss to follow-up were high. There was higher retention seen within the first month. Women interviewed at the end of the study reported that the intervention was positive. The cessation risk of any, and exclusive breastfeeding were not statistically different between the intervention and control groups.ConclusionsThis study provided valuable information on feasibility of the trial design and intervention. Modifications to the intervention, such as targeting women with lower breastfeeding self-efficacy, or combining home visits with technology and telephone follow-up may be more appropriate in a larger trial. Implementing the programme early during the antenatal phase and tailoring peer support to most appropriately sustain exclusive breastfeeding and other feeding modes should be incorporated in a future home-based peer support arm.Trial registrationNCT03705494 on 15 Oct 2018.

Project description:BACKGROUND:Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties. OBJECTIVE:Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention. DESIGN:Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates. SETTINGS:Two National Health Service health trusts and local authority children's social care. PARTICIPANTS:Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties. INTERVENTION:HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session. OUTCOMES:Primary feasibility outcome: participant retention rate. SECONDARY OUTCOMES:(i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). SECONDARY OUTCOMES:child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation. RESULTS:Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95%?CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3). CONCLUSION:HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported. TRIAL REGISTRATION NUMBER:ISRCTN14573230.

Project description:IntroductionMindfulness 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 analysisThis 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 disseminationEthics 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 numberChiCTR1800014741; Pre-results.

Project description:IntroductionA digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods.Methods and analysisInitially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13-19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation.Ethics and disseminationThe pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public.Trial registration numberISRCTN12437531.

Dataset Information

Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol.

Publications

Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets