THRIVE BY 3 Daycare to Promote Development/ Mental Health in 1&2 Year-olds (Tb3)

R

Regionsenter for barn og unges psykiske helse

Status

Completed

Conditions

Child Development
Childcare Quality

Treatments

Behavioral: Treatment as usual (TAU)
Behavioral: Thrive by Three

Study type

Interventional

Funder types

Other

Identifiers

NCT03879733
260624

Details and patient eligibility

About

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).

Full 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.

Enrollment

1,531 patients

Sex

All

Ages

12 to 35 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,531 participants in 2 patient groups

Intervention group
Experimental group
Description:
The group of childcare centers that will receive the intervention during 10 months from sept 2018 - June 2019
Treatment:
Behavioral: Thrive by Three
Wait-list control
Other group
Description:
Will receive no intervention and continue with business as usual during the primary intervention period Sept. 2018 - June 2019. Will receive the intervention from Sept. 2019 - June 2020.
Treatment:
Behavioral: Treatment as usual (TAU)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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