NCT03879733

THRIVE BY 3 Daycare to Promote Development/ Mental Health in 1&2 Year-olds

THRIVE BY 3 Preventive Knowledge Enhancement & Tailored Quality-building in Daycare to Promote Development/ Mental Health in 1&2 Year-olds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,531 (actual)
• Sponsor: Regionsenter for barn og unges psykiske helse · Academic / Other
• Sex: All
• Age: 12 Months – 35 Months
• Healthy volunteers: Accepted

Summary

This study evaluates a preventive, knowledge enhancement and tailored quality building intervention to promote development and mental health in 1 and 2 year-olds. Half of the participating childcare centers will get the intervention (intervention group) and half will get the intervention after 1 year (waitlist-control).

Detailed description

Mental health problems manifest already in preschool age and continue into middle and late childhood. However, research strongly indicates that mental health problems appear even among 1-2 year olds. Because 80% of Norwegian under 3 years attend childcare, and stay there for long hours, interventions targeting caregiver-child interactions may prove an important avenue towards universal prevention of mental health problems. Since requirements for high quality is not sufficiently met in many Norwegian childcare centers today, a cost-efficient, sustainable model of intervention is called for to enhance and track the quality of childcare for 1-3 year olds. The investigators in the study will break new grounds by, conducting a cluster randomized control trial of a newly developed comprehensive intervention for promoting mental health among toddlers in childcare, the Thrive by Three. Because, high quality childcare is in a unique position to prevent developmental trajectories leading to mental health problems and to early identify children in need of help, effective quality enhancing interventions will be of great value for the Norwegian society, both on individual, family, community and national level. The primary objective of the project is thus to investigate whether the intervention Thrive by Three will improve childcare quality, and strengthen children's mental health and development. It is hypothesized that the intervention will prove superior to the wait-list control after the 10 month intervention period and at 12 months follow-up with respect to childcare quality and children's mental health, development and well-being. Our secondary objective is to investigate the cost-effectiveness of the intervention and whether effects are moderated by characteristics of the children, caregivers and/or implementation outcomes. In a subsample of approximately 300 children the investigators will sample cortisol at two time points (pre and post intervention) to investigate whether quality enhancement alters the cortisol level in children in childcare, compared to cortisol secretion at home. User perspectives and experience with Thrive by Three will be captured through qualitative interviews.

Conditions

• Childcare Quality
• Child Development

Interventions

Type	Name	Description
BEHAVIORAL	Thrive by Three	The intervention consists of the following components: 1. Measurement of daycare quality with CLASS (Classroom Assessment Scoring System) 3 times during the intervention period 2. Feedback to group staff on 8 CLASS-quality dimensions 3. Monthly supervision of staff on two levels: supervision of daycare staff, and supervision of supervisors 4. Competence building with all staff: 3 full training days, plus 2 extra training days for pedagogical leaders/supervisors 5. Written material to parents, supervisors, and staff 6. Web page for staff and parents: tf3.no
BEHAVIORAL	Treatment as usual (TAU)	The wait-list control group will continue with their daily activities and work in the childcare as usual. The wait list control group will have received general information about the study prior to consenting, however no materials or are provided by project. The child-care centers in the control conditions will receive a gift certificate of 3000 Norwegian Crones (NOK) by the end of the intervention period.

Timeline

• Start date: 2017-10-16
• Primary completion: 2020-11-15
• Completion: 2021-12-31
• First posted: 2019-03-19
• Last updated: 2022-04-27

Locations

3 sites across 1 country: Norway