Dino Study: Daily Intervention-based Research on Nurturing Opportunities in Young Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorTilburg University

About this trial

The goal of this clinical trial is to evaluate the effectiveness of the Incredible Years Dinosaur Program in children aged 4 to 8 years with conduct problems. The main questions it aims to answer are:

* Does participation in the Dinosaur Child Program lead to greater improvements in children's emotional, social, and cognitive functioning, and reductions in externalizing behavior compared to a waitlist control group? * Does the intervention reduce emotional variability and daily behavior problems as captured through daily diary assessments? * Does the intervention improve daily parent-child dynamics, including reduced emotional escalation and more shared positive affect?

Researchers will compare children in the intervention group to those in the waitlist control group to see if the program leads to better emotional regulation, fewer behavior problems, and improved parent-child interactions.

Participants will:

* Be randomly assigned to either the intervention or waitlist control group (1:1) Receive 18 weekly small-group sessions (if in the intervention condition) using the Incredible Years Dinosaur Program * Complete daily diaries with their parent using the m-Path app during a 20-week period (baseline, intervention, follow-up) * Complete standardized pre- and post-intervention assessments via parent, teacher, and child reports

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 4 to 8 years

At least one parent or primary caregiver willing and able to participate in the study and complete daily diary assessments

Sufficient Dutch language proficiency in child and parent to complete questionnaires and daily diary reports

Parental indication that the child shows elevated or (sub)clinical levels of conduct problems in daily life (e.g., frequent defiance, aggression, or rule- breaking behavior

Disqualifiers

Intellectual disability in the child (IQ < 70)

Child lives primarily in a different household during weekdays (e.g., institutional care, full-time co-parenting arrangement)

Parent/child does not have sufficient Dutch language proficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • Incredible Years Dinosaur Child Program

    Behavioral

    The Incredible Years Dinosaur Child Program is a structured, manualized group intervention designed for children aged 4 to 8 years with elevated or (sub)clinical conduct problems. The program consists of 18 weekly group sessions lasting approximately two hours each. Sessions are delivered in small groups (5-6 children per group) by certified trainers and follow a developmentally appropriate, play-based curriculum. Intervention components include storytelling with puppets, role-play, video modeling, and group discussions. The program aims to enhance emotional regulation, social competence, and problem-solving skills. The Dutch version of the program is used in this study and implemented in both clinical and preventive settings.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Incredible Years Dinosaur ProgramExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in social competence (parent-reported and teacher-reported)

The Parent version (P-COMP) completed by parents The Teacher version (T-COMP) completed by teachers Both versions include items assessing prosocial behavior, cooperation, empathy, and emotional self-regulation. Scores from baseline (T1) and post-intervention (T2) will be compared to evaluate changes in social functioning across home and school contexts.

Time frame
Baseline (T1) to Post-Intervention (T2); ~19 weeks
2

Change in externalizing behavior (parent-reported and teacher-reported)

Externalizing behavior will be assessed using standardized instruments at two time points: The Eyeberg Child Behavior Inventory (ECBI) and Child Behavior Checklist (CBCL) completed by parents, and The Teacher's Report Form (c-TRF/TRF) completed by teachers. Both instruments are part of the Achenbach System of Empirically Based Assessment (ASEBA) and include subscales measuring aggressive and rule-breaking behavior. The primary outcome is the change in externalizing scores from baseline (T1) to post-intervention (T2), approximately 19 weeks apart.

Time frame
Baseline (T1) to Post-Intervention (T2); ~19 weeks
3

Change in executive functioning (parent-reported and teacher-reported)

Executive functioning will be measured with the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). The Parent Form (60 items) and Teacher Form (61 items) use a 3-point Likert scale (1 = never, 2 = sometimes, 3 = often) to rate everyday behaviors reflecting executive skills (for example, "Has trouble remembering things, even for a few minutes"). For this study the Global Executive Composite (GEC) will serve as the primary outcome. GEC scores from baseline (T1) and post-intervention (T2) will be compared to evaluate changes in children's executive functioning across home and school contexts.

Time frame
Baseline (T1) to Post-Intervention (T2); ~19 weeks
4

Change in child language and communication behavior (parent-reported)

Child language and communication functioning will be assessed using the Children's Communication Checklist - Second Edition, Dutch version (CCC-2-NL). This 70-item parent-report questionnaire covers both structural language skills (e.g., syntax, semantics) and pragmatic communication abilities (e.g., inappropriate initiation, use of context, nonverbal communication). Each item is rated on a 4-point scale (0 = "less than once a week or never" to 3 = "several times a day or always"). The General Communication Composite (GCC) will be used as the primary outcome measure to evaluate change in communicative functioning from baseline (T1) to post-intervention (T2).

Time frame
Baseline (T1) to Post-Intervention (T2); ~19 weeks

Secondary outcomes

1

Daily dynamic emotional processes (ESM-based)

This outcome captures children's daily emotional instability and problem-solving behaviors, measured using parent-child dyadic reports via the m-Path mobile app. Emotional instability is defined as within-person fluctuations in negative affect (e.g., anger, sadness), while coping is operationalized as the use of emotion regulation strategies reported by the child. These indicators are collected daily to examine how children's emotional self-regulation develops over the course of the intervention.

Time frame
Daily over 20 weeks
2

Daily behavioral processes within families (Dyadic ESM-based)

This outcome captures parent-child affective dynamics in daily life, based on separate reports from parents and children. Negative interactions are assessed through measures of emotional escalation, conflict, and anger. Positive interactions include shared emotional moments and expressions of warmth. These data allow for analysis of affective synchrony, divergence, and co-regulation over time, reflecting how the intervention impacts relationship quality.

Time frame
Daily over 20 weeks

Other outcomes

Sponsors and contacts

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Tilburg University

Lead sponsor

Netherlands Organisation for Scientific Research

Collaborator