Child Behavior Problem Clinical Trial
— SEP+Official title:
Effectiveness and Mechanisms of a Multi-Focused Prevention Program Combining Face to Face With Technology-Assisted Intervention for Preschoolers' Behavior Problems
Verified date | February 2023 |
Source | Babes-Bolyai University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 398 |
Est. completion date | June 10, 2022 |
Est. primary completion date | June 10, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 52 Months to 72 Months |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Romania | Babes-Bolyai University, Department of Psychology | Cluj-Napoca | Cluj |
Lead Sponsor | Collaborator |
---|---|
Babes-Bolyai University |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events (Peterson et al., 2013) | Adverse events procedures are informed by the STRONG STAR Consortium Procedure for the Monitoring of Adverse Events (a large multi-center study on Posttraumatic Stress Disorder in adults) (Peterson, Roache, Raj, & Young-McCaughan, 2013). Adverse events happening during the intervention and that are in temporal association with the participation in the study will be monitored and documented. | This outcome is measured only post-intervention (approximately 4 months after the pre-intervention measure),. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Parenting Young Children (PARYC; McEachern et al., 2012) | PARYC assesses parents' use of positive discipline strategies. It comprised 21 items loading on three subscales: Supporting Positive Behavior, Limit Setting, and Proactive Parenting. Items are rated on a 7-point Likert scale, ranging from 1 (not at all) to 7 (most of the time). Scores for each scale are obtained as the average ratings for each subscale. | Change from baseline parental positive discipline at 4 months. | |
Secondary | Parenting Scale (PS; Arnold et al., 1993) | The PS aims to assess parenting behaviors in response to children's behaviors by describing on a 7-point scale their reaction, with ratings closer to 1 suggesting more effective ways of responding, whereas ratings closer to 7 suggesting more ineffective ways of responding. Scores for the Over-reactivity and Laxness scales are computed as means. | Change from baseline over-reactivity and laxness at 4 months. | |
Secondary | Parental Stress Scale (PSS; Berry & Jones, 1995) | PSS is an 18-item measure assessing parental stress. Responses are coded on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The Parent Stress score is obtained by summing responses to all items. | Change from baseline parental stress at 4 months. | |
Secondary | Coping with Children's Negative Emotions (CCNES; Fabes et al., 1990; Mirabile, 2015) | CCNES contains 12 scenarios depicting emotion-eliciting situations for which parents are required to rate 7 possible reactions to their child's negative emotions, on a 7-point Likert scale ranging from 1 (very unlikely) to 7 (very likely). Means are obtained for each of the following scales: Distress Reactions, Punitive Reactions, Expressive Encouragement, Emotion-Focused Reactions, Problem-Focused Reactions, Minimization, and Ignoring. | Change from baseline coping strategies with children's negative emotions at 4 months. | |
Secondary | Revised Parental Emotion Regulation Inventory (PERI-2; Lorber et al., 2017) | PERI-2 contains 23 items which describe ways in which parents respond emotionally when their children misbehave. Each item is rated on a 7-point Likert scale, ranging from 1 (I never do this) to 7 (I very often do this). Means are computed for the following scales: Discipline Reappraisal, Discipline Suppression, Discipline Capitulation, and Discipline Escape. | Change from baseline parental emotion regulation strategies at 4 months. | |
Secondary | The Coparenting Relationship Scale (CRS; Feinberg et al., 2012) | The CRS measures parental perceptions about the extent to which they receive support from the partners on matters related to childrearing. Parents are requested to rate each item on a 7-point Likert scale ranging from 0 (not true of us) to 6 (very true of us). In the current study, the Coparenting Support and Coparenting Undermining will be employed. | Change from baseline coparenting support and undermining at 4 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03077321 -
Improving Access to a Primary Care Based Positive Parenting Program
|
N/A | |
Terminated |
NCT04075071 -
A Pilot Study of Teacher-Child Interaction Training - Universal in Head Start
|
N/A | |
Completed |
NCT04257331 -
Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China
|
N/A | |
Recruiting |
NCT04946253 -
SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care
|
N/A | |
Completed |
NCT06311084 -
IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
|
N/A | |
Completed |
NCT03283579 -
Fatty Acids and Attention Deficit and Hyperactivity Disorder Symptoms
|
||
Completed |
NCT04440228 -
TeamSTEPPS in School Mental Health
|
N/A | |
Completed |
NCT04786080 -
Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).
|
N/A | |
Recruiting |
NCT04821856 -
Evaluation of the Effectiveness of Cannabidiol in Treating Severe Behavioural Problems in Children and Adolescents With Intellectual Disability
|
Phase 2 | |
Completed |
NCT05452954 -
Psychosocial ADHD Interventions - Brief Parent Training
|
N/A | |
Active, not recruiting |
NCT05096611 -
Attachment and Biobehavioral Catch-up and Depression Treatment
|
N/A | |
Completed |
NCT06195579 -
Nurtured Heart Parenting Intervention for Child Behavioural Problems
|
N/A | |
Recruiting |
NCT05444205 -
The Pittsburgh Study Early Childhood
|
N/A | |
Completed |
NCT05519943 -
Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders
|
N/A | |
Completed |
NCT06274424 -
Hair Cortisol and Symptoms in Children With Psychopathology During CBT
|
N/A | |
Active, not recruiting |
NCT06040996 -
Evaluation of Improving Parenting Skills Adult ADHD (IPSA): A New Parent Training Program for Parents With ADHD
|
N/A | |
Completed |
NCT05776576 -
Physical Activity and Recreation School Program for Special Needs Individuals and Their Parents
|
||
Recruiting |
NCT04942145 -
Effect of Virtual Reality on Dental Patients
|
N/A | |
Enrolling by invitation |
NCT04763720 -
Implementing Dyadic Developmental Psychotherapy (DDP) - Evaluation Research
|
||
Recruiting |
NCT04635969 -
Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
|
N/A |