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

Not Applicable

Not yet recruiting

• Conditions: Behavior Problems in Children; Oppositional Behavior; Parent-Child Relations; Social Skills

• Registration Number: NCT07051642
• Lead Sponsor: Tilburg University

Brief Summary

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

Detailed Description

The Dino Study is a two-arm randomized controlled trial (RCT) designed to evaluate the effectiveness of the Incredible Years (IY) Small Group Dinosaur Child Program in young children (ages 4 to 8) with elevated or (sub)clinical levels of conduct problems. Conduct problems at this age are associated with long-term risks for poor academic, social, and mental health outcomes, yet current interventions rarely account for individual differences in children's emotional responsiveness and daily functioning. This study introduces the Dinosaur Program in the Netherlands and combines conventional pre- and post-intervention assessments with an intensive longitudinal diary design to examine both group-level effects and intra-individual mechanisms of change.

A total of 120 children and one parent per family will be recruited through partnerships with primary schools and mental health organizations. Families are eligible if the child is aged 4 to 8 years, has sufficient Dutch language skills, and shares daily contact with the participating caregiver. Children with an intellectual disability (IQ \< 70) or insufficient Dutch fluency will be excluded. After informed consent, families will be randomly allocated (1:1) to either the intervention or waitlist control condition. The intervention group will participate in 18 weekly 2-hour group sessions delivered by certified IY group leaders. The waitlist group receives care-as-usual and is offered the intervention after the posttest.

The Incredible Years Dinosaur Child Program is a structured, manualized group intervention based on cognitive-behavioral principles. It aims to enhance emotional regulation, prosocial behavior, and problem-solving abilities through playful, developmentally appropriate activities such as puppet play, role-play, group discussion, and storytelling. While parents do not receive formal training, they are indirectly exposed to program content through letters and reading assignments. The program has been widely implemented and evaluated internationally, but this study is the first to integrate it with daily diary methods to capture day-to-day variability in children's behavior and parent-child dynamics.

Primary outcomes focus on externalizing behavior, cognitive and social-emotional functioning, assessed via standardized parent, teacher, and child instruments. Secondary outcomes are derived from daily diaries and capture fluctuations in emotions, behavior, and dyadic emotional exchanges. Daily assessments will be collected using the m-Path app, completed jointly by parent and child every evening over a 20-week period (1 week baseline, 18 weeks intervention, 1 week follow-up). This approach enables fine-grained modeling of emotional variability and relational processes in the child's natural environment.

The study is informed by the Environmental Sensitivity Framework, which posits that children vary in their responsiveness to environmental input. Emotional sensitivity will be operationalized as moment-to-moment fluctuations in daily negative affect prior to the intervention. Multilevel and time-series analyses will be used to evaluate overall treatment effects as well as dynamic, intra-individual change patterns. Key hypotheses include: (1) children in the intervention group will show greater improvements in externalizing behavior and social functioning than those in the control group; (2) daily negative affect and behavior problems will decline more in the intervention group; and (3) intervention effects will be moderated by children's baseline emotional sensitivity.

Findings will contribute to the emerging field of precision prevention by identifying which children benefit most from structured group interventions and under what conditions. The integration of Intensive Longitudinal Data (ILD )with a randomized trial design allows for a mechanistic, personalized understanding of behavioral change in young children and their families.

Study Timeline

• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Status Verified: 2025-07
• Study First Posted: 2025-07-04
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-10
• Study Start: 2025-09-15
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in social competence (parent-reported and teacher-reported)	Baseline (T1) to Post-Intervention (T2); ~19 weeks	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.
Change in externalizing behavior (parent-reported and teacher-reported)	Baseline (T1) to Post-Intervention (T2); ~19 weeks	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.
Change in executive functioning (parent-reported and teacher-reported)	Baseline (T1) to Post-Intervention (T2); ~19 weeks	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.
Change in child-assessed emotional understanding and problem-solving skills	Baseline (T1) to Post-Intervention (T2); ~19 weeks	Children's emotional understanding and problem-solving skills will be assessed using two structured, age-appropriate tasks: The Wally Feeling Test, which measures the child's ability to recognize and explain emotional expressions in cartoon-based vignettes.; The Wally Problem Solving Test, which presents illustrated social dilemmas and asks children to generate possible solutions.; Responses are coded for emotional awareness, perspective-taking, and cognitive flexibility. Change from baseline (T1) to post-intervention (T2) will be evaluated to determine the impact of the intervention on child-level socio-emotional competencies.
Change in child language and communication behavior (parent-reported)	Baseline (T1) to Post-Intervention (T2); ~19 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Daily dynamic emotional processes (ESM-based)	Daily over 20 weeks	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.
Daily behavioral processes within families (Dyadic ESM-based)	Daily over 20 weeks	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.