Ignite Creation Date:
2024-05-06 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05057728
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2021-09-13
Brief Title:
Effectiveness of the Social-Emotional Prevention Program Enhanced Version
Sponsor:
Babes-Bolyai University
Organization:
Babes-Bolyai University
Study Overview
Official Title:
Effectiveness and Mechanisms of a Multi-Focused Prevention Program Combining Face to Face With Technology-Assisted Intervention for Preschoolers Behavior Problems
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEP
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 childrens negative emotions and adaptive ER strategies as well as fewer negative coping strategies with childrens 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 childrens use of adaptive ER strategies will mediate the interventions effect on externalizinginternalizing problems in a similar vein it is hypothesized that improved social skills will mediate the interventions effect on childrens externalizinginternalizing 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 programs 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 interventions effectiveness on parenting practices parental stress and parent ERcoping
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 childrens negative emotions and adaptive ER strategies as well as fewer negative coping strategies with childrens 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 childrens use of adaptive ER strategies will mediate the interventions effect on externalizinginternalizing problems in a similar vein it is hypothesized that improved social skills will mediate the interventions effect on childrens externalizinginternalizing 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 programs 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 interventions effectiveness on parenting practices parental stress and parent ERcoping
Detailed Description:
The first step in recruiting participants will require approaching preschool headmasters with a detailed description of the studys 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 childrens 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 childrens social-emotional skills and risk of externalizinginternalizing 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 regulationcoping and stress will be gathered at T1 and T2 Also parents will be asked to fill out measures of childrens social-emotional skills and externalizinginternalizing 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 andor parent training such as deterioration of child andor 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 childrens 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 facilitators 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 interventions 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
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 childrens 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 facilitators 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 interventions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None