Zurich Equity Prevention Project Parental Participation and Integration
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Child Behavior assessed with the Child Behaviour Checklist (CBCL)
研究概览
简要总结
ZEPPELIN (Zurich Equity Prevention Project with Parents Participation and Integration) is a longitudinal, randomized controlled intervention study. The main objective is to examine the effectiveness of the early intervention program "Parents As Teachers" (PAT) in psychosocially disadvantaged families. This includes four aims:
- Identification of children at risk at an early age, using an interdisciplinary network;
- Investigation of the acceptability of the program by the parents;
- Evaluation of the intervention process and efficacy during and immediately after program implementation;
- Evaluation of the efficacy in terms of child academic performance.
详细描述
The preschool years represent a critical time period, with major developmental milestones in cognitive, linguistic, motoric, and emotional areas. Families tend to manage this sensitive phase in different ways, which results in an uneven distribution of educational opportunities at school entry. However, prior evidence shows that these disparities can be reduced by means of evidence-based programs in early childhood care and education (ECCE). The main focus is on the prevention of learning and behavioral disorders; for small children, this occurs by means of strengthening parenting skills.
ZEPPELIN (Zurich Equity Prevention Project with Parents Participation and Integration) is a longitudinal, randomized controlled intervention study. The main objective is to examine the of the early intervention program "Parents As Teachers" (PAT) in psychosocially disadvantaged families. This includes four aims:
- Identification of children at risk at an early age, using an interdisciplinary network;
- Investigation of the acceptability of the program in parents;
- Evaluation of the intervention process and efficacy during and immediately after program implementation;
- Evaluation of the efficacy in terms of child academic performance.
Families were recruited in the suburbs of Zurich, Switzerland, shortly before or after giving birth. Baseline measurements were conducted at 3 months postnatal (t0), before participants were assigned to either the intervention group (IG, receiving the early intervention program PAT) or control group (CG) condition, using a stratified block randomization. Follow-up data was collected at three measurement time points around the first, second and third birthday of the children (t1, t2, t3).
Further follow-up measurements will be conducted in 2017 (t4; in the 1st year of kindergarten), 2018 (t5; in the 2nd year of kindergarten), 2019 (t6; after school transition), and in 2021 (t7; in the 3rd year of primary school). This will allow us to investigate medium-term and long-term effects of early developmental conditions.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Families shortly before or after child birth
- •At risk situations (presence of at least two items from the core fields described below, while protective factors attenuating these risks appear absent)
- •Risk factors: core fields
- •Personal risks, such as neglected appearance (subjective rating based on visual impression), low level of education (no further education after compulsory school years), early parenthood (mother younger than 20 years), alcohol and drug abuse, illness, disability, violence, unwanted pregnancy
- •Familial risks, such as lack of self-management and planning skills), single parents, siblings with an age difference of 18 months or less, serious partnership conflicts (close to break up)
- •Social risks, such as lack of social integration and support (no or only very few relationships outside the family), antisocial environment (violence, crime, prostitution)
- •Material risks, such as confined living space (less than one room per person), unemployment (one or both parents), financial problems (dependency on welfare, debts)
排除标准
- •Factors that may mitigate the risks, such as familial support, stable and reliable parents, clear and transparent family structures
- •Immigrants without a permanent residence permit
- •Severe illness or disability of the child or of the parents which require hospitalization or long-term treatment
- •Other ongoing intensive treatments or child protection procedures
研究组 & 干预措施
Parents As Teachers (PAT)
c.f. intervention
干预措施: Parents As Teachers (PAT) (Other)
control group condition
Families in the control group condition did not receive the home visiting program PAT, but were informed about support services in their community. The use of these services was permitted for ethical reasons; however, parents were regularly asked about the nature and intensity of the retrieved services. Additionally, all parents received incentives, such as greeting cards, small birthday presents, and monetary reimbursements.
结局指标
主要结局
Child Behavior assessed with the Child Behaviour Checklist (CBCL)
时间窗: up to 6 years
Child Behaviour Checklist (CBCL)
Child development assessed with the Developmental Observation Scales (EBD 48-72)
时间窗: up to 1 year
German Developmental Observation Scales for child care centers (EBD 48-72)
Language skills assessed with the German test "Linguistically Competent"
时间窗: up to 5 years
"Linguistically Competent"
Child Health assessed with the Health questionnaire
时间窗: up to 9 years
Health questionnaire
Child development assessed with the Snijders-Oomen nonverbal intelligence test (SON-R)
时间窗: up to 7 years
Snijders-Oomen nonverbal intelligence test (SON-R)
Parent-child interaction assessed with the Child-Adult-Relationship-Experimental Index (CARE-Index)
时间窗: up to 4 years
Child-Adult-Relationship-Experimental Index (CARE-Index)
Home environment assessed with the Home Observation Measurement of the Environment (HOME)
时间窗: up to 7 years
Home Observation Measurement of the Environment (HOME)
Child development assessed with the Bayley Scale of Infant and Toddler Development (BSID III)
时间窗: up to 3 years
Bayley Scale of Infant and Toddler Development (BSID III)
Language skills assessed with the Language Evaluation Short form SBE-2-KT; SBE-3-KT)
时间窗: up to 3 years
Language evaluation short form (SBE-2-KT; SBE-3-KT)
Mathematical skills assessed with the TEDI-MATH test
时间窗: up to 5 years
Mathematical skills (TEDI-MATH)
Child Behavior assessed with the Strengths and Difficulties Questionnaire (SDQ)
时间窗: up to 5 years
Strengths and Difficulties Questionnaire (SDQ)
Parent-child interaction assessed with the Emotional Availability (EA) Scales
时间窗: up to 3 years
Emotional Availability (EA) Scales
次要结局
- Parenting assessed with the Alabama Parenting Questionnaire (APQ)(up to 3 years)
- Risk and protective factors assessed with the German version of the Parenting-Stress-Index (EBI)(up to 3 years)
- Parental self-efficacy assessed with the Self-Efficacy in Infant Care Scale (SICS)(up to 4 years)
- Parental self-efficacy assessed with the Parenting Sense of Competence Scale (PSOC)(up to 3 years)
- Parental depressivity assessed with the subscale of the Brief Symptom Inventory (BSI)(up to 6 years)
- Social network assessed with the Social Network Scales(up to 10 years)
- Risk and protective factors assessed with the Heidelberg Stress Scale (HBS)(up to 8 years)
- Educational attitudes assessed with the German test Educational Attitudes Scale (EMKK)(up to 4 years)