Effectiveness of the Social-Emotional Prevention Program Enhanced Version

NCT05057728 | Completed

• 1 other identifier: PN-III-P1-1.1-TE-2019-0226
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Behavior Problem

Keywords

social-emotional competence; externalizing problems; internalizing problems; parenting practices; parent stress

Outcome Measures

Primary Outcomes (4)

• Social Skills Improvement System (SSIS; Gresham & Elliott, 2002)

  The Social Skills Scale from the SSIS is a measure of children's social skills for parents and teachers. Both raters are required to assess the frequency of children's behaviors on a 4-point Likert scale ranging from 0 (never) to 3 (almost always). The scale is comprised of subscales measuring Cooperation, Communication, Assertion, Responsibility,. Empathy, Self-Control, and Engagement. Scores on each scale can be obtained by summing ratings for each item. Also, a total Social Skills score can be obtained by adding scores from each subscale.

  Change from baseline social skills at 4 months.

• Emotion Regulation Skills Questionnaire (ERSQ; Mirabile, 2014)

  The ERSQ will be used as a measure of children's use of 13 regulatory strategies in response to negative emotions (sadness, anger, and fear) grouped into scales assessing adaptive (Self-soothing, Comfort-seeking, Support-seeking, Self-Directed Speech, Instrumental Coping, Information Gathering, Verbal Distraction, Self/Object Oriented Distraction) vs. maladaptive (Focus on Distressing Object, Venting, Aggression, Avoidance, Suppression) ER strategies. Parents and teachers rate children on their use of each ER strategy on a 4-point Likert scale ranging from 0 (never) to 3 (very much). Scores are obtained as the average scores for each regulatory strategy across the 3 emotions.

  Change from baseline emotion regulation at 4 months.

• Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2000)

  The CBCL is filled out by parents who are requested to respond on a 3-point Likert scale, ranging from 0 (absent) to 2 (occurs often). Responses on the Anxiety/Depression, Emotionally Reactive, Withdrawn, and Somatic Complaints will be employed for obtaining a measure of children's Internalizing Problems, whereas Aggressive Behavior and Attention Problems scores will provide a measure of Externalizing Problems. Scores for the broad-band syndrome scales are computed by adding ratings on each corresponding subscale.

  Change from baseline externalizing/internalizing problems at 4 months.

• Caregiver-Teacher Report Form (C-TRF; Achenbach & Rescorla, 2000)

  The C-TRF evaluates teachers' perception regarding the frequency of children's Anxiety/Depression, Emotionally Reactive, Withdrawn, Somatic Complaints, Aggressive Behaviors and Attention Problems. Responses are coded on a 3-point Likert scale, ranging from 0 (absent) to 2 (occurs often). Scores are computed by adding ratings for each type of problems and obtaining a broad-band score for either Internalizing Problems or Externalizing Problems.

  Change from baseline externalizing/internalizing problems at 4 months.

Secondary Outcomes (6)

• Parenting Young Children (PARYC; McEachern et al., 2012)

  Change from baseline parental positive discipline at 4 months.

• Parenting Scale (PS; Arnold et al., 1993)

  Change from baseline over-reactivity and laxness at 4 months.

• Parental Stress Scale (PSS; Berry & Jones, 1995)

  Change from baseline parental stress at 4 months.

• Coping with Children's Negative Emotions (CCNES; Fabes et al., 1990; Mirabile, 2015)

  Change from baseline coping strategies with children's negative emotions at 4 months.

• Revised Parental Emotion Regulation Inventory (PERI-2; Lorber et al., 2017)

  Change from baseline parental emotion regulation strategies at 4 months.

Other Outcomes (1)

• Adverse Events (Peterson et al., 2013)

  This outcome is measured only post-intervention (approximately 4 months after the pre-intervention measure),.

Study Arms (1)

Intervention group (SEP+)

EXPERIMENTAL

SEP+ is designed as a multi-focused (child, teacher, parent) school-based intervention, which can be employed as either a universal (i.e. targeting all children) or an indicated prevention program (i.e. targeting specifically children at risk for behavior problems). The SEP+ intervention comprises three types of intervention: 1) the classroom-based intervention in the form of a curriculum of 43 activities (2-3 activities/week) delivered over 4-months aimed at developing social-emotional skills; 2) a 6-sessions (2-2.5h/session) teacher training focused on increasing the use of positive discipline strategies and developing coaching skills for supporting children's social-emotional learning; and 3) a 6 sessions parent training (1.5.-2h/session) aiming to teach ways to manage parenting stress, to increase parent-child quality time, support children's emotion regulation and problem-solving, as well as increase positive discipline strategies.

Behavioral: Social-Emotional Prevention Program enhanced version

Interventions

Social-Emotional Prevention Program enhanced version BEHAVIORAL

The intervention is provided for all children for whom parental consent is obtained. The intervention includes a classroom curriculum, teacher training and parent training.

Also known as: SEP+

Intervention group (SEP+)

Eligibility Criteria

• Age: 52 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• all children for whom parental informed consent is provided
• child age between 4.5-6 years at the time of participant recruitment
• children classified at risk for externalizing problems, based on their score (cutoff T \> 67) on the Externalizing Problems scale from the CBCL, and C-TRF respectively (for statistical analyses in relation to the indicated intervention)

You may not qualify if:

• previous child participation in a program designed to enhance social-emotional skills and/or parent participation to another parent training program
• child's age below 4.5 years or over 6 years at the time of participant recruitment
• children classified not at risk based on their score (cutoff T \< 67) on the Externalizing Problems scale from the CBCL, and C-TRF respectively (for statistical analyses in relation to the indicated intervention)

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes-Bolyai University, Department of Psychology

Cluj-Napoca, Cluj, 400015, Romania

Location

Study Officials

• Catrinel A Stefan, PhD

  Babes-Bolyai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PhD

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 27, 2021
• Study Start: January 10, 2022
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Information will be available within 1 month from the time when the study's outcomes are published.
• Access Criteria: Data sets pertaining to each publication will be available for all researchers. Requests concerning any other information which are not directly shared in the IPDs can be requested by email from the Principal Investigator (catrinelstefan@psychology.ro).

Locations

RO (1)