Inclusion/Exclusion criteria.

Preschoolers ≥ 3.5 to 5.11 years old are eligible to enroll and participate in this study. Children are ineligible if any of the following apply: exhibit characteristics or diagnosed with syndromes or diseases that would affect participation in the motor skills intervention and/or exhibit characteristics or had a previous diagnosis of any major illness, developmental, and/or physical disability since birth. If a child is deemed ineligible due to an above condition, but have parental consent, they will be able to participate in the treatment but no data will be collected on these individuals.

Recruitment.

After receiving human subjects IRB approval, the following procedures will occur regarding participant recruitment and the informed consent process. Parent(s)/guardian(s) will receive an information letter from the Principal Investigator notifying them of the PATH-SR Study at the beginning of the school year. The letter will provide a brief description of the study along with a statement from the school administrators indicating that parent(s) are not obligated to participate. Members of the research team will be present during morning drop-offs and afternoon pick-ups to answer any questions from parents/guardians. All parents/guardians who return a consent form, regardless of whether they agreed to participate in the PATH-SR Study, will receive a one-time cash incentive of $5.00. In addition to parental consent, verbal assent will be obtained from each preschooler. Parents will receive reminder letters for each upcoming PATH-SR assessment and a developmental report of their child’s findings from each assessment (i.e., motor skills, physical activity, health outcomes, SR outcomes). Each center will be provided with aggregated data of the findings.

Theoretical principles.

CHAMP is grounded in Achievement Goal Theory. This theory originates from educational psychology and focuses on the learners’ motivation to learn [41, 43, 44], since goals for learning influence intrinsic motivation. Achievement Goal Theory refers to the beliefs, attributions, and affect that contribute to one’s behaviors and represents how an individual approaches, engages, and responds to various activities [42, 43]. Individuals can take either a mastery- (task-) or performance- (ego-) orientation [42, 71]. Performance- (ego-) individuals focus on ensuring that their performance is successful and superior to others while mastery- (task-) individuals engage in learning for the sake of learning and are less threatened by failure. Mastery- (task-) oriented individuals often have higher intrinsic motivation [42, 43] exhibit an intrinsic interest in learning [44, 72] and have positive attitudes towards learning [72, 73].

Learning environments can be intentionally and purposefully structured to encourage learners to adopt a mastery- (task-) orientation to learning. These environment are called mastery-motivational climates and are created using Epstein’s TARGET structures [46] (see Table 1). Applying the TARGET structures to the learning environment redistributes the ownership to the learner and allows them to autonomy to navigate the intervention climate, make their own choices on how, where, and in what level of difficulty they engage in and practice new skills. In the case of CHAMP, allowing the child the autonomy to navigate the mastery-motivational climate fosters self-navigated engagement, self-selections of learning groups, and self-paced learning. These activities and expectations require a child to demonstrate and continually practice the cognitive, emotional and behavioral regulation skills that are hallmarks of effective SR (see Table 1). Therefore, even while the primary learning outcomes of CHAMP are motor skills and health behaviors, the theoretical principles (i.e., achievement-goal theory) and implementation (i.e., TARGET structures) applied during the program are likely to promote SR in children.

Intervention session design.

The CHAMP motor skills intervention will be delivered across a dose of 2,155 minutes. The intervention will be completed 3 days per week across 19 weeks (i.e., 16 weeks of the CHAMP intervention plus 3 weeks in between for winter and spring breaks) in an academic school year. Each 45-minute CHAMP session will consist of three parts: (a) 3–5 min of introductory activity, (b) 35–38 min of motor skill instruction and practice delivered as a mastery-motivational climate, and (c) 3–5 min motor skill closure activity and review. Each CHAMP session will include 3–4 motor skill stations that will rotate across 15 different motor skills. The stations will all be designed using a “slanted rope effect” to allow a range of difficulty in practice and engagement in the stations that ranges from easy to difficult. All stations and the ability to manipulate difficulty of engagement within each stations will be taught to the children during the introductory activity, and then during 35–38 minutes of motor skill instructions and practice children will self-navigate through the activities. During this time, instructors move about the intervention and encourage children to continually engage in the intervention as well as will provide individualized feedback and instruction in accordance with the TARGET structures. Instructors provide feedback on motor skill performance using best pedagogical practices including cue words, modeling, and physical manipulation. For example, instructors may notice a child is not stepping contralaterally during throwing. They will recognize this individual performance and encourage the child to engage in better throwing performances by verbal prompts (e.g., “step with the other foot”), modeling (e.g., “watch me! Step like this”), external cues (e.g., sticker on the foot they should step forward with), or physical manipulation (e.g., picking up and moving the correct foot). Once the child changes their movement pattern and steps forward with the contralater foot, the instructor will evaluate this change in performance based on self-referenced norms and praise the child for their individual change in performance.

While children and instructors share responsibility for the authority of the CHAMP sessions, children should engage in the session. During the introductory activity and wrap-up and review, children are asked to sit in a circle in the middle of the classroom and listen to the instructor explain the activities/stations of the day (introductory activity) or recap the daily activitys (wrap up and review). During the 35–38 min of motor skill instruction and practice delivered as a mastery-motivational climate children are granted autonomy to move around the space as they desire. Ultimately, where they engage, how long they engage, what level of difficulty they engage with, and their peer structures during practice are decided by the children with continued encouragement and re-direction from instructors. For example, a child could elect to spend the entire 35–38 minutes practicing their throws at a moderate level of difficulty by themselves. Alternatively, a child could elect to only spend 3 minutes at throwing at an easy level of difficulty then move to running with a group of three to four peers. Both examples constitute “successfully” engaging in CHAMP and require children to manage their emotions, focus attention, persist, plan, and evaluate their actions in order to improve their motor competence and perceived motor competence and enhance their engagement in PA [41, 42, 46]. All these behaviors are linked with SR which support the potential of CHAMP to improve SR in this population.

Intervention instructors.

CHAMP will be implemented by two motor development researchers who are Ph.D. students. The lead instructor has 6 years of experience implementing the CHAMP intervention and was involved in the development of the program. The second instructor has a degree in physical education and a background in motor intervention implementation. Additional research personnel (n = 1–2) will be present to assist with other managerial tasks for the intervention (e.g., ensure that the cameras are recording, record attendance, equipment set-up and breakdown, collecting and returning of children to classroom, fidelity checks, etc.).

All research personnel will undergo training before the start of the intervention. The training takes approximately 40 hours to complete. The training will include readings and discussion on (a) Achievement Goal Theory and mastery climates in general and in regards to movement interventions, (b) cue words best practices in motor skill instruction and feedback, and (c) best pedagogical practices for preschool-aged children. All lead instructors must undergo additional training whereby they will watch three previously recorded instructional sessions of the CHAMP intervention and discuss how achievement goal theory and the TARGET structures were implemented in the intervention. Lastly, each instructor will complete a mock CHAMP session and practice station set up, skill and CHAMP instruction, individual feedback and recognition on motor performance, and CHAMP closing. Both the reviewed videos and the mock CHAMP session will be completed under the direction of the lead author and creator of CHAMP (LER), and instructors have to demonstrate 100% fidelity with CHAMP and TARGET structures prior to the start of the intervention.

Intervention fidelity.

Fidelity checks on the TARGET structures and instruction will also be completed at every session to ensure the intervention adheres to the TARGET protocol. For the past 14 years, the following fidelity checks have been used to ensure the extent to which the CHAMP intervention is implemented as intended [40, 47–49, 62–68]. Daily checks will be completed to ensure the dose, adherence, quality of delivery, intervention alignment with core constructs and intervention protocol, and etc. All intervention sessions will be digitally recorded to enable future reviews of each session if needed. For each session, a research staff member (i.e., not the CHAMP instructors) will complete the following fidelity checks that address dose, instruction, and TARGET stuctures. For dose, the checks will record the start and finish of each session (i.e., to calculate the total minutes of the intervention session), the amount of time devoted to skill instruction and demonstration, and the amount of time children engaged in the practice of motor skills. Research staff members will evaluate the instruction provided during each CHAMP session to ensure that it aligns with the pre-determined CHAMP lesson plan. Specifically, the checks will ensure that clear instruction for each motor activity station are provided, the use of the provided critical cue words and that an accurate demonstration, ensure that instructors check for student understanding, compliance with the CHAMP lesson plan, and if modified a description of the deviation will be recorded. These instructional checks will also record the type of feedback (specific, corrective, and/or evaluative) provided to the child, along with the use of manual manipulation to aid motor skill learning. Finally, the TARGET structures will be used to ensure that there are three motor skills activity with 3–4 levels of task difficulty present (Task), children have the opportunity to independently choose their engagement in the session (Authority), feedback focuses on progress, effort, and improvement (Recognition and Evaluation), children have the option/choice to work in small group, with peers, or individually (Grouping), and lastly the 35–38 minutes of motor skill instruction and practice was self-paced based on the individual child’s level of engagement (Time). As noted in the intervention training section, two, PhD instructors will serve as the interventionist for this study and will be trained by the PI of the project. In addition to each session being digitally recorded, instructors will wear wireless microphones to aid in assessing the intervention fidelity. Instructors will receive feedback regarding their instruction weekly. Fidelity checks on the TARGET structures and instruction will also be completed at every session to ensure the intervention adheres to the TARGET protocol.

Control condition.

The outdoor recess/free play program is the early learning centers’ current motor program for accreditation and will serve as the control condition for this study. Outdoor recess/free play will be implemented according to the existing procedures within the centers. Each class will receive two, 30–45 min outdoor recess (free play) periods each day. For this study, the control group will receive two, 30–45 min per day outdoor sessions, whereas the treatment (CHAMP) group will receive one, 30–45 min outdoor session each day after their nap, as the morning recess session was replaced with the CHAMP intervention on days the intervention will be implemented. The centers’ outdoor programs consist of outdoor free-play activities on a large playground area with a variety of play structures (e.g., swings, slides, ladders) that promote physical activity, gross motor skills, balance/stability, and movement skills. No planned instruction or activities will be provided to the preschoolers during outdoor recess. Classroom teachers and the research personnel will be asked to confirm that the daily outdoor recess sessions were completed with a check-off sheet.

Overall analysis plans.

We will apply transformations to assure normality, run descriptive statistics, and assess potential covariates to include. While maximum effort will be made to retain all participants and minimize the amount of missing data, we anticipate there will be some data lost-to-follow-up and incomplete measures. Therefore, we will address missing data in the analysis plan by applying advanced statistical techniques, such as “multiple imputations” using PROC MI in SAS and IVEWARE SAS macro. Our overall approach will be to employ multivariate analysis to assess associations among key variables using the appropriate models based on the distribution of the data (i.e., normal, categorical data, count data, reaction time data). Since this is a cluster-randomized trial, adjusting the covariates (e.g., child sex, age, race/ethnicity) will aid in controlling additional unbalancesess due to the limited sample size. All analysis will be done using SAS 9.3 or R 4.1.0 [96–98]. Additionally, we will perform “intent to treat” analysis and assume all subjects comply to the assigned group. Findings/results from the study will also following the CONSORT guidelines.

Power considerations.

When we calculate the sample size and power, we assumed the intra-cluster correlation is 0.3. The achievable power is calculated for a detectable effect size, which is the detectable mean difference standardized by the square root of sample variance. Given the randomization design with 70 children in the intervention group and 50 children in the control group, we have 80% power to detect a difference in cognitive SR, behavioral SR, or emotional SR with an effect size of 0.52 and a Type I error level of 0.05.

Specific analysis plan for Aim 1.

Examine the immediate (pre- to post-test) intervention effects of CHAMP (compared to control participants) on cognitive SR (cognitive flexibility, working memory, attention shifting), behavioral SR (behavioral inhibition), and emotional SR (emotion regulation). The immediate post-intervention effect of CHAMP (compared to control participants) on each SR outcome variable will be evaluated at post-intervention. We will examine descriptive statistics for both pre-and post-intervention SR outcome variables for each group. The change in cognitive SR, behavioral SR, and emotional SR scores will be compared between the intervention (CHAMP) and control groups using regression models, adjusting for other confounding factors. We assume randomization will be successful and we will monitor throughout the trial. It is always good practice to monitor along the way and we will do so, but randomization may be imperfect as this is a randomized cluster trial taking place in the real word (i.e., Head Start setting). If randomization does not work this will lead to biased results and methodology, our planned analyses to adjust other variables will be considered. Random effects will be included in the model to accommodate for the potential within-cluster correlations due to nested classroom data. We anticipate that some children will have only partial adherence to the intervention (i.e., attend a subset of sessions), thus we will also conduct a dose-response analysis where dose corresponds to number of sessions. We will investigate the amount of attrition from pre-to post-intervention, and attempt to identify baseline (or pre-intervention) predictors of dropping out. The information will indicate possible bias in the change estimates.

Specific analysis plan for Aim 2.

Examine the associations between SR (cognitive SR, behavioral SR, and emotional SR) and changes in health behaviors (motor competence, perceived competence, physical activity) and health outcomes (body mass index, waist circumference). We will further evaluate the associations between changes in SR and changes in children’s health behaviors and outcomes, using regression models. More specifically, we will examine the strength of association between each SR variable and our outcomes of interest using bivariate analyses to compare change in SR to change in motor competence, perceived competence, and PA (using an alpha value of p < .05). To test whether the strength of association varies by intervention status, we will use multivariate regression models (controlling for covariates as needed) to examine the association of SR and outcomes in each group (CHAMP and control). Similarly, random effects will be included in the model to accommodate for the potential within-cluster correlations from nested classroom data. We will further apply Structural Equation Models (SEM) to evaluate whether the CHAMP intervention has a causal effect on children’s health outcomes mediated through SR.

Data management.

Extreme care to ensure high-quality and secure data will be exercised. All data will be stored securely at the University of Michigan. All data will have only a numerical identifier so that individual respondents, except for video data, cannot be identified. All data will be reported as aggregate statistics and no individuals will be recognizable from the data reported. All data will be scanned for consistency, errors of omission, and appropriateness of the response, and 30% of data will be checked by a blinded member of the research team. Once a coded and cleaned data file has been prepared, frequency distributions and descriptive statistics (means, standard deviations, and ranges) for each of the measured variables will be used for consistency checks and to verify the comparability of the groups. Logic check programs will be run to ensure that each data point falls within the expected range or corresponds to possible values in the codebook. These tracking system files will be maintained on a secure server at the University of Michigan. Data will be analyzed using SAS 9.3 or R 4.1.0 [96–99]. All members of the study team will be required to complete the web-based National Institutes of Health University of Michigan Responsible Conduct of Research Training Program. The investigative team will engage in ongoing data management training, data monitoring, and measurement training over the course of the investigation. Rewards and incentives will be incorporated after each assessment time point to aid in participant engagement.