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Parents and children active together: a randomized trial protocol examining motivational, regulatory, and habitual intervention approaches.

ABSTRACT: 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 .

SUBMITTER: Grant SJ

PROVIDER: S-EPMC7507646 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Parents and children active together: a randomized trial protocol examining motivational, regulatory, and habitual intervention approaches.

Grant Stina J SJ Beauchamp Mark R MR Blanchard Chris M CM Carson Valerie V Gardner Benjamin B Warburton Darren E R DER Rhodes Ryan E RE

BMC public health 20200921 1

<h4>Background</h4>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 intervent ...[more]

PMID: 32957959

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Project description:AimsThe efficacy of batterer intervention programs to reduce intimate partner violence (IPV) is questionable, with individuals with alcohol problems particularly unlikely to benefit. We examined whether adding adjunctive alcohol intervention to batterer intervention reduced the likelihood of substance use and violence relative to batterer intervention alone.DesignRandomized clinical trial.SettingBatterer intervention programs in Rhode Island, USA.ParticipantsA total of 252 hazardous drinking men in batterer intervention programs. Participants were randomized to receive 40 hours of standard batterer program (SBP) or the SBP plus a 90-minute alcohol intervention (SBP + BAI). None withdrew due to adverse effects. Data were collected at baseline, 3-, 6- and 12-month follow-up, with follow-up rates of 95, 89 and 82%, respectively.MeasurementsSubstance use was measured with a well-validated calendar-assisted interview. Violence was measured with a validated questionnaire. Arrest records were obtained for all participants. The primary substance use outcome was drinks per drinking day (DPDD) and the primary violence outcome was frequency of any physical IPV.FindingsRelative to SBP alone, men receiving SBP + BAI reported consuming fewer DPDD at 3-month follow-up [B = -1.36, 95% confidence interval (CI): -2.65, -0.04, P = 0.04] but not 6- or 12-month follow-up. In secondary analyses, men receiving SBP + BAI reported significantly greater abstinence at 3- (B = 0.09, 95% CI: 0.03, 0.14, P = 0.002) and 6-month (B = 0.06, 95% CI: 0.01, 0.11, P = 0.01) follow-up but not 12-month follow-up. There were no significant differences in physical IPV between men receiving SBP and men receiving SBP + BAI. In secondary analyses, men receiving SBP + BAI reported less severe physical aggression at 3-month (IRR = 0.18, 95% CI: 0.05, 0.65, P = 0.009) but not 6- or 12-month follow-up. Men receiving SBP + BAI reported less severe psychological aggression (B = -1.24, 95% CI: -2.47, -0.02, P = 0.04) and fewer injuries to partners at 3- and 6-month follow-up (IRR = 0.33, 95% CI: 0.12, 0.92, P = 0.03), with differences fading by 12 months.ConclusionsMen with a history of intimate partner violence and hazardous drinking who received a batterer intervention plus an alcohol intervention showed improved alcohol and violence outcomes initially, but improvements faded by 12 months.

Project description:IntroductionEarly 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 analysisThis 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 disseminationThe 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 registrationISRCTN87634685.

Project description:The perinatal mortality review meeting that takes place within the hospital following a stillbirth or neonatal death enables clinicians to learn vital lessons to improve care for women and their families for the future. Recent evidence suggests that parents are unaware that a formal review following the death of their baby takes place. Many would welcome the opportunity to feedback into the meeting itself. Parental involvement in the perinatal mortality review meeting has the potential to improve patient satisfaction, drive improvements in patient safety and promote an open culture within healthcare. Yet evidence on the feasibility of involving bereaved parents in the review process is lacking. This paper describes the protocol for the Parents' Active Role and Engangement iN the review of their Stillbirth/perinatal death study (PARENTS 2) , whereby healthcare professionals' and stakeholders' perceptions of parental involvement will be investigated, and parental involvement in the perinatal mortality review will be piloted and evaluated at two hospitals.We will investigate perceptions of parental involvement in the perinatal mortality review process by conducting four focus groups. A three-round modified Delphi technique will be employed to gain a consensus on principles of parental involvement in the perinatal mortality review process. We will use three sequential rounds, including a national consensus meeting workshop with experts in stillbirth, neonatal death and bereavement care, and a two-stage anonymous online questionnaire. We will pilot a new perinatal mortality review process with parental involvement over a 6-month study period. The impact of the new process will be evaluated by assessing parents' experiences of their care and parents' and staff perceptions of their involvement in the process by conducting further focus groups and using a Parent Generated Index questionnaire.This study has ethical approval from the UK Health Research Authority. We will disseminate the findings through national and international conferences and international peer-reviewed journals.

Project description:BackgroundThe COVID-19 pandemic has introduced or amplified stress and challenge within couples' relationships. Among those who are particularly vulnerable to heightened conflict and lower relationship satisfaction during this time are interparental couples with young children, whose relationships may have already been tenuous prior to the pandemic. Stress within the interparental relationship may have ripple effects on all family subsystems and child adjustment. The Love Together Parent Together (L2P2) program is a brief, low-intensity writing intervention adapted for parents of young children that was designed to reduce conflict-related distress and prevent declines in relationship satisfaction. Based on an original writing intervention by Finkel and colleagues, L2P2 has adapted the intervention duration and study population to be appropriate to the current global context. This study will examine the key feasibility metrics related to this adapted program with the goal of identifying problems and informing parameters of future pilot and/or main RCTs.MethodsThe current study is a non-randomized feasibility study, using a single-arm, pre-test/post-test design to primarily assess the feasibility of an evaluative RCT, and to secondarily assess the potential effects on outcomes to be used in a future RCT. Couples will be recruited through three community-based agencies with the goal of obtaining a socio-demographically diverse sample. The first 20 couples to enroll will be included. Baseline and post-intervention surveys will be conducted, and a writing intervention will take place (three 7-min sessions over the course of 5 weeks). The primary outcomes will be feasibility metrics of recruitment rates, appropriateness of eligibility criteria, sample diversity, retention, uptake, adherence, and acceptability. In addition, we will develop an objective measure of couple "we-ness" based on an analysis of writing samples. The secondary outcomes will include couples' measures (i.e., relationship quality, perceived partner responsiveness, self-reported responsiveness, conflict-related distress), and additional family outcomes (i.e., parent-child relations, parental/child mental health). Criteria for success are outlined, and failure to meet the criteria will result in adaptations to the measurement schedule, intervention design, recruitment approach, and/or other elements of the program.DiscussionThis feasibility study will inform several components of the procedures used for a subsequent pilot RCT, in which we will examine the feasibility of the methodology used to evaluate the program (e.g., randomization, attrition to follow-up assessment/across groups, and sample size estimation, preliminary effectiveness), as well as the main RCT, which will investigate the effectiveness of the intervention on primary outcome measures and mediating pathways.Trial registrationClinicalTrials.gov , NCT05143437.

Project description:BackgroundMusic therapy is a standard palliative care service in many pediatric and adult hospitals; however, most research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. This study builds on prior work examining psychosocial mechanisms of action underlying an Active Music Engagement (AME) intervention, designed to help manage emotional distress and improve positive health outcomes in young children with cancer and parents (caregivers), by examining its effects on biomarkers of stress and immune function.MethodsThis two-group randomized controlled trial (R01NR019190) is designed to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute B- or T-cell Lymphoblastic Leukemia (ALL) and T-cell Lymphoblastic Lymphoma (TLyLy) treatment. Child/parent dyads (n = 228) are stratified (by age, site, risk level) and randomized in blocks of four to the AME or attention control condition. Each group receives one session (30-minutes AME; 20-minutes control) during weekly clinic visits (4 weeks standard risk B-cell ALL; 8 weeks high risk B-cell ALL/T-cell ALL/TLyLy). Parents complete questionnaires at baseline and post-intervention. Child/parent salivary cortisol samples are taken pre- and post-session (sessions 1-4). Child blood samples are reserved from routine draws before sessions 1 and 4 (all participants) and session 8 (high risk participants). We will use linear mixed models to estimate AME's effect on child/parent cortisol. Examining child/parent cortisol as mediators of AME effects on child and parent outcomes will be performed in an ANCOVA setting, fitting the appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach. Graphical plots and non-linear repeated measures models will be used to examine dose-response relationship of AME on child/parent cortisol.DiscussionDuring pediatric cancer treatment there are special challenges that must be considered when measuring cortisol and immune function. In this manuscript we discuss how we addressed three specific challenges through our trial design. Findings from this trial will increase mechanistic understanding of the effects of active music interventions on multiple biomarkers and understanding of dose-response effects, with direct implications for clinical practice.Trial registrationClinicalTrials.gov: NCT04400071.

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:Background and objectiveVaccine uptake during pregnancy remains low. Our objectives were to describe 1) development and adaptation of a clinician communication training intervention for maternal immunizations and 2) obstetrics and gynecology (ob-gyn) clinician and staff perspectives on the intervention and fit for the prenatal care context.MethodsDesign of the Motivational Interviewing for Maternal Immunizations (MI4MI) intervention was based on similar communication training interventions for pediatric settings and included presumptive initiation of vaccine recommendations ("You're due for two vaccines today") combined with motivational interviewing (MI) for hesitant patients. Interviews and focus group discussions were conducted with ob-gyn clinicians and staff in five Colorado clinics including settings with obstetric physicians, certified nurse midwives (CNMs), and clinician-trainees. Participants were asked about adapting training to the ob-gyn setting and their implementation experiences. Feedback was incorporated through iterative changes to training components.ResultsInterview and focus group discussion results from participants before (n = 3), during (n = 11) and after (n = 25) implementation guided intervention development and adaptation. Three virtual, asynchronous training components were created: a video and two interactive modules. This virtual format was favored due to challenges attending group meetings; however, participants noted opportunities to practice skills through role-play were lacking. Training modules were adapted to include common challenging vaccine conversations and live-action videos. Participants liked interactive training components and use of adult learning strategies. Some participants initially resisted the presumptive approach but later found it useful after applying it in their practices. Overall, participants reported that MI4MI training fit well with the prenatal context and recommended more inclusion of non-clinician staff.ConclusionsMI4MI training was viewed as relevant and useful for ob-gyn clinicians and staff. Suggestions included making training more interactive, and including more complex scenarios and non-clinician staff.

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Parents and children active together: a randomized trial protocol examining motivational, regulatory, and habitual intervention approaches.

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Parents and children active together: a randomized trial protocol examining motivational, regulatory, and habitual intervention approaches.

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