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

NCT ID: NCT07051642

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Incredible Years Dinosaur Program

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.

Group Type: EXPERIMENTAL

Incredible Years Dinosaur Child Program

Intervention Type: 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.

Waitlist Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Incredible Years Dinosaur Child Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Netherlands Organisation for Scientific Research

OTHER_GOV

Sponsor Role: collaborator

Tilburg University

OTHER

Sponsor Role: lead

Responsible Party

Rabia Chhangur

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rabia Chhangur, PhD

Role: CONTACT

R.R.Chhangur@tilburguniversity.edu

+31 13 466 3118

Rianne Hurkmans

Role: CONTACT

A.J.C.Hurkmans@tilburguniversity.edu

+31 13 466 3118

References

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.

Reference Type: BACKGROUND

PMID: 11693589 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18221346 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40920805 (View on PubMed)

Other Identifiers

406.XS.24.03.088

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TSB_RP2172

Identifier Type: -

Identifier Source: org_study_id