Dataset Information

Protocol Evaluating the effectiveness of a school-based group programme for parents of children at risk of ADHD: the 'PArents, Teachers and CHildren WORKing Together (PATCHWORK)' cluster RCT protocol.

ABSTRACT:

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration

ISRCTN87634685.

SUBMITTER: Sayal K

PROVIDER: S-EPMC3437425 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Publications

Protocol Evaluating the effectiveness of a school-based group programme for parents of children at risk of ADHD: the 'PArents, Teachers and CHildren WORKing Together (PATCHWORK)' cluster RCT protocol.

Sayal Kapil K Daley David D James Marilyn M Yang Min M Batty Martin J MJ Taylor John A JA Pass Sarah S Sampson Christopher James CJ Sellman Edward E Valentine Althea A Hollis Chris C

BMJ open 20120903 5

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

PMID: 22945963

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Project description: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.

Project description:BACKGROUND:Regular physical activity (PA) is associated with many health benefits during childhood, and tracks into desirable PA patterns and health profiles in adulthood. Interventions designed to support these behaviours among young children are critical. Family-based interventions focusing on parent-child activities together (i.e., co-activity) among preschool-aged children are warranted. Targeting parental support practices can increase the frequency of co-activity, however interventions must move beyond merely building intention and planning skills for successful maintenance. Interventions designed to increase co-activity habit strength may facilitate the sustainability and thus impact child PA. The purpose of this study is to compare the effects of three intervention conditions designed to increase child PA through co-activity: a standard education condition (information about benefits), a planning (action planning, coping planning)?+?education condition and a habit (context-dependent repetition from prompts and cues)?+?planning +education condition. METHODS/DESIGN:A longitudinal three-arm parallel design randomized trial will compare three conditions over six months. Families are eligible if they have at least one child between 3y and 5y that is not meeting 60mins/day of moderate to vigorous physical activity (MVPA). The primary outcome (child MVPA) is assessed via accelerometry at baseline, six weeks, three months and six months (primary endpoint). Intervention materials targeting co-activity are delivered post baseline assessment, with booster sessions at six weeks and three months. Parental co-activity habit, parent-child co-activity and other behavioural constructs are also assessed via questionnaire at all measurement occasions. As tertiary outcomes, parental PA is measured via accelerometry and co-activity is measured via a Bluetooth-enabled proximity feature. A total of 106 families have been recruited thus far from the Greater Victoria region. The study is ongoing with a minimum target of 150 families and an anticipated recruitment completion date of August 2022. DISCUSSION:This protocol describes the implementation of a randomized trial evaluating the effectiveness of a habit formation group compared with a planning group and an education only group to increase child PA through targeting parent-child co-activity. This information could prove useful in informing public health initiatives to promote PA among families with preschool-aged children. TRIAL REGISTRATION:This trial was prospectively registered on clinicaltrials.gov in February 2016, identifier NCT03055871 .

Project description:BackgroundLevels of physical activity (PA) in UK children are much lower than recommended and novel approaches to its promotion are needed. The Children, Parents and Pets Exercising Together (CPET) study is the first exploratory randomised controlled trial (RCT) to develop and evaluate an intervention aimed at dog-based PA promotion in families. CPET aimed to assess the feasibility, acceptability and potential efficacy of a theory-driven, family-based, dog walking intervention for 9-11 year olds.MethodsTwenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group. Families in the intervention group were motivated and supported to increase the frequency, intensity and duration of dog walking using a number of behaviour change techniques. Parents in the intervention group were asked to complete a short study exit questionnaire. In addition, focus groups with parents and children in the intervention group, and with key stakeholders were undertaken. The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute (cpm). Intervention and control groups were compared using analysis of covariance. Analysis was performed on an intention to treat basis.ResultsTwenty five families were retained at follow up (89%) and 97% of all outcome data were collected at baseline and follow up. Thirteen of 14 (93%) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable. There was a mean difference in child total volume of PA of 27 cpm (95% CI -70, 123) and -3 cpm (95% CI -60, 54) for intervention and control group children, respectively. This was not statistically significant. Approximately 21% of dog walking time for parents and 39% of dog walking time for children was moderate-vigorous PA.ConclusionsThe acceptability of the CPET intervention and outcome measures was high. Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable, but did not result in a significant increase in child PA in this exploratory trial.Trial registrationISRCTN85939423.

Project description:BackgroundSiblings 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.MethodsWe 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.DiscussionSIBS-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 registrationClinicalTrials.gov NCT04056884 . Registered in August 2019.

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:Working memory, used to temporarily store and mentally manipulate information, is important for children's learning. It is therefore valuable to understand which (contextual) factors promote or hinder working memory performance. Recent research shows positive associations between positive parent-child and teacher-student interactions and working memory performance and development. However, no study has yet experimentally investigated how parents and teachers affect working memory performance. Based on attachment theory, the current study investigated the role of parent and teacher emotional support in promoting working memory performance by buffering the negative effect of social stress. Questionnaires and an experimental session were completed by 170 children from grade 1 to 2 (Mage = 7 years 6 months, SD = 7 months). Questionnaires were used to assess children's perceptions of the teacher-student and parent-child relationship. During an experimental session, working memory was measured with the Corsi task backward (Milner, 1971) in a pre- and post-test design. In-between the tests stress was induced in the children using the Cyberball paradigm (Williams et al., 2000). Emotional support was manipulated (between-subjects) through an audio message (either a weather report, a supportive message of a stranger, a supportive message of a parent, or a supportive message of a teacher). Results of repeated measures ANOVA showed no clear effect of the stress induction. Nevertheless, an effect of parent and teacher support was found and depended on the quality of the parent-child relationship. When children had a positive relationship with their parent, support of parents and teachers had little effect on working memory performance. When children had a negative relationship with their parent, a supportive message of that parent decreased working memory performance, while a supportive message from the teacher increased performance. In sum, the current study suggests that parents and teachers can support working memory performance by being supportive for the child. Teacher support is most effective when the child has a negative relationship with the parent. These insights can give direction to specific measures aimed at preventing and resolving working memory problems and related issues.

Dataset Information

Protocol Evaluating the effectiveness of a school-based group programme for parents of children at risk of ADHD: the 'PArents, Teachers and CHildren WORKing Together (PATCHWORK)' cluster RCT protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration

Publications

Protocol Evaluating the effectiveness of a school-based group programme for parents of children at risk of ADHD: the 'PArents, Teachers and CHildren WORKing Together (PATCHWORK)' cluster RCT protocol.

Similar Datasets

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