Clinical trial NCT03879733: THRIVE BY 3 Daycare to Promote Development/ Mental Health in 1&2 Year-olds
Official title: THRIVE BY 3 Preventive Knowledge Enhancement & Tailored Quality-building in Daycare to Promote Development/ Mental Health in 1&2 Year-olds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childcare Quality
Child Development
Keywords: childcare
quality
universal prevention
mental health
well-being
Lead sponsor: Regionsenter for barn og unges psykiske helse
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: BI Norwegian Business School - Oslo campus
name: University of Washington
name: The Research Council of Norway
First posted: 2019-03-19
Enrollment: 1531
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participating childcare centers are randomized to either a wait list control- group or an intervention group. The wait-list control group will receive the intervention after 1 year.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Children: All children aged 12 months to 36 months attending one of the selected childcare-centers.
* Child care centers: Childcare centers with groups for children aged 12-36 months was selected within each municipality, after the municipalities had consented to participate in the study. Child care centers volunteered to participate in the study.

Exclusion Criteria:

* Children: None
* Child-Care centers: Child care centers in the selected municipalities with only children older than 36 months.

Primary outcomes:
measure: Classroom Assessment Scoring System - Toddler (CLASS) (la Paro, M., Hamre, B., & Pianta, R., 2012)
timeFrame: Baseline, 5 months, 10 months and 22 months. Note: not possible at 22 months due to Covid-19
measure: Child Behavior Checklist for preschool children (CBCL)(Achenbach, T. M., 2000)
timeFrame: Baseline, 10 months and 22 months (one year follow up)
measure: C- Teacher report form for preschool children (C-TRF)(Achenbach, T. M., 2000)
timeFrame: Baseline, 10 months and 22 months (one year follow up)
measure: The Brief Infant-Toddler Social and emotional Assessment (BITSEA) (Briggs-Gowan, M. J., Carter A.S. , Irwin J.R., Wachtel K. & Cicchetti D.V., 2004)
timeFrame: Baseline, 10 months and 22 months (one year follow up)
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Regional center for child and adolescent mental health, Eastern and southern Norway
state: Nydalen
city: Oslo
country: Norway
facility: Norwegian Buisness School, BI
city: Trondheim
country: Norway
facility: Norwegian university of Science and Technology (NTNU)
Study officials:
affiliation: RegionsenterRBUP
name: Elisabet S. Buoen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buoen ES, Lekhal R, Lydersen S, Berg-Nielsen TS, Drugli MB. Promoting the Quality of Teacher-Toddler Interactions: A Randomized Controlled Trial of "Thrive by Three" In-Service Professional Development in 187 Norwegian Toddler Classrooms. Front Psychol. 2021 Nov 18;12:778777. doi: 10.3389/fpsyg.2021.778777. eCollection 2021.
citation: Lekhal R, Drugli MB, Berg-Nielsen TS, Buoen ES. A Model of Intervention and Implementation of Quality Building and Quality Control in Childcare Centers to Strengthen the Mental Health and Development of 1-3-Year Olds: Protocol for a Randomized Controlled Trial of Thrive by Three. JMIR Res Protoc. 2020 Oct 13;9(10):e17726. doi: 10.2196/17726.