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

NCT07051642 | Not Yet Recruiting

• 2 other identifiers: TSB_RP2172406.XS.24.03.088
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

Incredible Years Dinosaur Program; Conduct problems; Emotional sensitivity; Parent-child interaction; Daily diary; Experience Sampling Method; Randomized controlled trial; Behavioral intervention

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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.

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

• 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.

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

• 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).

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

• Change in child-assessed emotional understanding and problem-solving skills

  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.

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

Secondary Outcomes (2)

• Daily dynamic emotional processes (ESM-based)

  Daily over 20 weeks

• Daily behavioral processes within families (Dyadic ESM-based)

  Daily over 20 weeks

Study Arms (2)

Incredible Years Dinosaur Program

EXPERIMENTAL

Children in this arm will participate in the Incredible Years Small Group Dinosaur Child Program, a structured, evidence-based behavioral intervention designed for children aged 4-8 with conduct problems. The program consists of 18 weekly sessions of approximately two hours each, delivered in small groups by certified trainers. The sessions use play-based activities (e.g., puppets, storytelling, role-play) to promote emotional regulation, prosocial behavior, and problem-solving skills.

Behavioral: Incredible Years Dinosaur Child Program

Waitlist Control Group

NO INTERVENTION

Children in this arm will not receive any structured intervention during the 18-week study period but will continue to access usual care or services as needed. After completing the post-intervention assessment, they will be offered the Incredible Years Dinosaur Program outside of the research context, on a voluntary basis.

Interventions

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.

Incredible Years Dinosaur Program

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tilburg University: lead
• Netherlands Organisation for Scientific Research: collaborator

Related Publications (3)

• Webster-Stratton C, Reid J, Hammond M. Social skills and problem-solving training for children with early-onset conduct problems: who benefits? J Child Psychol Psychiatry. 2001 Oct;42(7):943-52. doi: 10.1111/1469-7610.00790.

  PMID: 11693589 BACKGROUND

• Webster-Stratton C, Jamila Reid M, Stoolmiller M. Preventing conduct problems and improving school readiness: evaluation of the Incredible Years Teacher and Child Training Programs in high-risk schools. J Child Psychol Psychiatry. 2008 May;49(5):471-88. doi: 10.1111/j.1469-7610.2007.01861.x. Epub 2008 Jan 21.

  PMID: 18221346 BACKGROUND

• Chhangur RR, Smalle EHM, Dejonckheere E, van der Zwaag G. The Dino Study: Rationale and protocol for a randomized controlled trial of the Incredible Years Dinosaur Program with daily assessments. PLoS One. 2025 Sep 8;20(9):e0330597. doi: 10.1371/journal.pone.0330597. eCollection 2025.

  PMID: 40920805 DERIVED

MeSH Terms

Conditions

Social Skills; Hypersensitivity

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Immune System Diseases

Central Study Contacts

Rabia Chhangur, PhD

CONTACT

+31 13 466 3118; R.R.Chhangur@tilburguniversity.edu

Rianne Hurkmans

CONTACT

+31 13 466 3118; A.J.C.Hurkmans@tilburguniversity.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blinded trial in which the outcomes assessors (e.g., coders) are unaware of participant group allocation. Participants, parents, and group leaders are not blinded due to the nature of the behavioral intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Participants (children aged 4-8 years and one parent per family) are randomly assigned (1:1) to either the intervention group, which receives the Incredible Years Dinosaur Program, or a waitlist control group. Both groups are assessed at baseline and after the 18-week study period. The waitlist group receives the intervention after the final assessment but is not included in the intervention analysis.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 4, 2025
• Study Start: September 15, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share