Effectiveness of the Social-Emotional Prevention Program Enhanced Version
Condition: Child Behavior Problem
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The current study is intended to investigate the effectiveness of the Social-Emotional
      Prevention Program enhanced version (SEP+) for increasing preschoolers' social-emotional
      competencies and reducing their risk for behavior problems.

      Hypotheses for the current study are put forward for child- and parent-related outcomes.
      First, for the SEP+ effects for child-related outcomes, the investigators expect that: 1)
      intervention group children will be rated significantly higher on measures of
      social-emotional competencies (social skills and positive emotion regulation strategies (ER))
      compared to children from the wait-list control group (primary outcomes); and 2) children
      assigned to the intervention will be rated significantly lower on externalizing, as well as
      internalizing problems (primary outcomes). In addition, for parent-related outcomes the
      hypotheses are: 1) intervention group parents will report significantly more positive
      parenting practices, and coparenting support, as well as significantly fewer negative
      parenting practices, coparenting undermining, and parenting stress compared to control group
      parents (secondary outcomes); and 2) intervention group parents will report significantly
      more positive coping strategies with children's negative emotions and adaptive ER strategies,
      as well as fewer negative coping strategies with children's negative emotions and less
      maladaptive ER strategies in comparison with control group parents (secondary outcomes).

      Additionally, the investigators aim to test potential intervention mechanisms. First, in the
      case of child-related outcomes, it is expected that children's use of adaptive ER strategies
      will mediate the intervention's effect on externalizing/internalizing problems; in a similar
      vein, it is hypothesized that improved social skills will mediate the intervention's effect
      on children's externalizing/internalizing problems. Furthermore, moderator effects of gender
      on adaptive emotion regulation strategies and externalizing problems will be tested.

      For the parenting intervention, it is expected that program's effect on positive parenting
      practices and stress will be mediated by the use of positive coping strategies, parental ER
      and coparenting support. Also, coparenting undermining and parental reported adverse events
      are hypothesized to moderate the intervention's effectiveness on parenting practices,
      parental stress, and parent ER/coping.
    

Detailed description: 
      The first step in recruiting participants will require approaching preschool headmasters with
      a detailed description of the study's aims and the benefits of participating in the SEP+
      intervention for both teachers and parents. All recruited schools will further inform parents
      of enrolled children regarding the study. Parents will be asked to provide informed consent
      for their children's participation in the study. Also, they will be asked to make a choice
      regarding their own participation to the parent training component. Afterwards, all
      classrooms from a particular school will be randomly assigned to either the SEP+ intervention
      or the wait-list control group. Data on the SEP+ effectiveness will be gathered at
      pre-intervention (January 2022) and at 4-months post-intervention (June 2022) for both
      conditions, intervention and control, respectively. Primary outcomes related to children's
      social-emotional skills and risk of externalizing/internalizing problems will be assessed at
      both baseline (T1) and immediately after the end of the intervention (T2) based on teacher
      and parent ratings. A similar approach will be employed for secondary outcomes. More
      specifically, data on self-reported parental discipline strategies, emotion regulation/coping
      and stress will be gathered at T1 and T2. Also, parents will be asked to fill out measures of
      children's social-emotional skills and externalizing/internalizing problems (primary
      outcomes), as well as measures related to parenting practices, parenting stress and parental
      ER (secondary outcomes). Both types of outcomes will be assessed at T1 and at T2, whereas
      parents will report about the number of adverse events only at T2. Any adverse events
      associated with the exposure to the classroom curriculum and/or parent training such as
      deterioration of child and/or parent mental health will be monitored by the research team. If
      such events occur, these will be reported to The Scientific Council of the Babes-Bolyai
      University.

      As the SEP+ is comprised of multiple interventions, monitoring procedures will be employed
      for all components. First, regarding the implementation of the classroom curriculum, teachers
      will be required to fill out a self-monitoring implementation form, which will include
      children's attendance rates, number of implemented classroom activities, and teachers' use of
      intervention methods. In addition, teachers will be required to provide access to the
      research team to 25% filmed classroom activities. The quality of implementation for each
      activity by two independent raters. The teacher training will be conducted with approximately
      12-15 participants in each group. Teachers will be required to participate in all 6 training
      sessions. Fidelity of implementation in accordance with the facilitator's manual will be
      conducted for half of the sessions (from sessions 2 to 5) by two independent raters based on
      video recordings of these sessions. Checklists will contain items describing facilitators'
      ability to implement specific methods of training, as well as their skills regarding group
      management and ways to support teachers' use of learned strategies in delivering the
      classroom curriculum. The parent training will also consist of 6 sessions, which will be
      delivered to groups of 8-10 parents. For each parent training, group fidelity checks will be
      conducted for 50% of the parent training sessions (sessions 2 to 5) by two independent raters
      based on videotaped recordings. Similar to the teacher training, facilitators will be
      assessed on their ability to deliver each training method according to the manual, as well as
      their interaction and communication skills with parents.

      Approximately 30 classrooms will be recruited for the purposes of the current study. Given an
      expected rate of 15-30% dropout form pre- to post-intervention and that some parents might
      not provide consent for children to participate, the investigators estimate that the final
      sample will include a total of approximately 250-300 participants. A GPower a priori sample
      size estimation for a medium effect size, a significance level of .05 and power of .80
      suggests that 41 participants are required in each group.

      Data for the current study will be collected online employing Google Forms and all items will
      be marked mandatory to reduce the likelihood of missing data from each set of parent- and
      teacher-rated questionnaires. In order to handle missing data an iterative Markov chain Monte
      Carlo (MCMR) method will be employed.

      For the purposes of the current study two types of analyses will be conducted: 1) for the
      effectiveness of the universal intervention (for all children in the sample), and 2) for the
      indicated intervention levels (children who score above the cutoff (T score > 67) on the
      Externalizing Problems score on the Child Behavior Checklist and the Caregiver-Teacher Report
      Form. For the universal intervention multi-level mixed models controlling for clustering
      effects will be conducted to test the intervention's effectiveness and moderator effects.
      Additionally, mediator effects will be tested employing multi-level meditation models in
      MPlus. For the indicated intervention, mixed ANOVAs will be conducted for assessing SEP+
      effectiveness. Moderator and mediator effects will be assessed employing Model 1 and Model 4
      from the Process add-on for Statistical Package for Social Sciences.
    

Intervention name(s): Social-Emotional Prevention Program enhanced version
Intervention type(s): Behavioral
Intervention description(s): The intervention is provided for all children for whom parental consent is obtained. The intervention includes a classroom curriculum, teacher training and parent training.
Other intervention name(s): SEP+
Intervention model: Single Group Assignment
Intervention model description: Participants in the current study will be assigned to either: 1) the intervention condition, which will receive the SEP+; or 2) the wait-list control group. A partially-randomized controlled trial (RCT) will be employed, in which schools will be randomly assigned to either the intervention or control group, so that all classrooms within a school will either receive the SEP+ or not. This was done in order to prevent contamination effects, which are more likely to occur when classrooms from the same school participate in the intervention and others do not.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: social-emotional competence; externalizing problems; internalizing problems; parenting practices; parent stress