THRIVE BY 3 Preventive Knowledge Enhancement & Tailored Quality-building in Daycare to Promote Development/ Mental Health in 1&2 Year-olds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,531
- 试验地点
- 6
- 主要终点
- Classroom Assessment Scoring System - Toddler (CLASS) (la Paro, M., Hamre, B., & Pianta, R., 2012)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The participating child-care centers, staff, parents and children are blind to the study conditions prior to consenting. After randomization the participants know if they get the intervention or not.
入排标准
- 年龄范围
- 12 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Children: None
- •Child-Care centers: Child care centers in the selected municipalities with only children older than 36 months.
结局指标
主要结局
Classroom Assessment Scoring System - Toddler (CLASS) (la Paro, M., Hamre, B., & Pianta, R., 2012)
时间窗: Baseline, 5 months, 10 months and 22 months. Note: not possible at 22 months due to Covid-19
CLASS is used to measure change in process quality from pre-intervention (baseline) to half way through the intervention (5 months) period, post-intervention (10 months) as well as at 12 months follow up (22 months). CLASS is a multidimensional observational measure of process quality in daycare, for toddlers. Trained observers observe each group of children and staff for 3 loops of 15 minutes. Quality is assessed along 8 dimensions and 2 quality domains. Scores are given on a scale from 1-7 with 7 indicating higher quality, except on the dimension negative climate, where 1 indicates higher quality. The dimension score of negative climate is reversed when domain scores are calculated. Scores of 1-2 indicates low quality, 3-5 mediocre, and 6-7 high. Scores for each cycles are calculated, and averaged to give the dimension scores. Domain scores are then calculated based on the averaged domain scores.
Child Behavior Checklist for preschool children (CBCL)(Achenbach, T. M., 2000)
时间窗: Baseline, 10 months and 22 months (one year follow up)
100 item parent report of child behavioral, emotional and social problems. each item is rated as 0 (Not True),1 (Somewhat or Sometimes True), or 2 (Very True, or Often True). Low scores indicate fewer problems. The measure is used to measure change in problem behavior during the intervention period (from baseline to end of intervention), and used as an outcome measure at post intervention (10 months) to see whether children in childcare center where the quality has positively changed during the intervention period will have less problem behavior.
C- Teacher report form for preschool children (C-TRF)(Achenbach, T. M., 2000)
时间窗: Baseline, 10 months and 22 months (one year follow up)
100 item teacher report of child behavioral, emotional and social problems. Each item is rated as 0 (Not True),1 (Somewhat or Sometimes True), or 2 (Very True, or Often True). Low scores indicate fewer problems. The measure is used to measure change in problem behavior during the intervention period (from baseline to end of intervention), and used as an outcome measure at post intervention (10 months) to see whether children in childcare center where the quality has positively changed during the intervention period will have less problem behavior.
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)
时间窗: Baseline, 10 months and 22 months (one year follow up)
BITSEA is a 42 item instrument to assess social-emotional/behavioral problems and delays in social-emotional competence in toddlers. The BITSEA is completed both by parents and child care staff. We use BITSEA to measure change in problem behavior during the intervention period (from baseline to end of intervention), and BITSEA is also used as an outcome measure at post intervention (10 months) and at 12 months follow up (22 months) to see whether children in childcare centers where the quality has positively changed during the intervention period will have less problem behavior.
次要结局
未报告次要终点
研究者
Elisabet Solheim Buøen
Clinical psychologist, PhD
Regionsenter for barn og unges psykiske helse