Early Support From Birth Onwards: ZEPPELIN

Study Overview
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Brief Summary
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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.

Detailed Description
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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. ZEPPELIN 0-3 is the first ECCE program in Switzerland that specifically targets and recruits at risk families from birth on. Families then participate in an experimental field study including a longitudinal control group comparison. As such, ZEPPELIN fills an important gap in the current literature.

Official Title
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Zurich Equity Prevention Project Parental Participation and Integration

Conditions
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Early Intervention (Education)

Intervention / Treatment
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* Other: Parents As Teachers (PAT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parents As Teachers (PAT)<br>c.f. intervention | Other: Parents As Teachers (PAT)<br>* A trained PAT parent educator (pediatric nurses in this study) visits families at their homes, approximately two times a month (individual frequencies may vary depending on specific risk factors) until the children are three years old. PAT is an educational home visitation program that aims to a) help parents to understand child developmental aspects and improve their parenting skills, b) detect developmental shortcomings, c) prevent child abuse and neglect, and d) enhance school preparedness. Additionally, the project offers monthly group meetings.<br>|
| No Intervention: control group condition<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child development assessed with the Bayley Scale of Infant and Toddler Development (BSID III) | Bayley Scale of Infant and Toddler Development (BSID III) | up to 3 years | 
| Child development assessed with the Snijders-Oomen nonverbal intelligence test (SON-R) | Snijders-Oomen nonverbal intelligence test (SON-R) | up to 7 years | 
| Child development assessed with the Developmental Observation Scales (EBD 48-72) | German Developmental Observation Scales for child care centers (EBD 48-72) | up to 1 year | 
| Language skills assessed with the Language Evaluation Short form SBE-2-KT; SBE-3-KT) | Language evaluation short form (SBE-2-KT; SBE-3-KT) | up to 3 years | 
| Mathematical skills assessed with the TEDI-MATH test | Mathematical skills (TEDI-MATH) | up to 5 years | 
| Language skills assessed with the German test Linguistically Competent | Linguistically Competent | up to 5 years | 
| Child Health assessed with the Health questionnaire | Health questionnaire | up to 9 years | 
| Child Behavior assessed with the Child Behaviour Checklist (CBCL) | Child Behaviour Checklist (CBCL) | up to 6 years | 
| Child Behavior assessed with the Strengths and Difficulties Questionnaire (SDQ) | Strengths and Difficulties Questionnaire (SDQ) | up to 5 years | 
| Parent-child interaction assessed with the Child-Adult-Relationship-Experimental Index (CARE-Index) | Child-Adult-Relationship-Experimental Index (CARE-Index) | up to 4 years | 
| Parent-child interaction assessed with the Emotional Availability (EA) Scales | Emotional Availability (EA) Scales | up to 3 years | 
| Home environment assessed with the Home Observation Measurement of the Environment (HOME) | Home Observation Measurement of the Environment (HOME) | up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk and protective factors assessed with the Heidelberg Stress Scale (HBS) | Heidelberg Stress Scale (HBS) | up to 8 years | 
| Risk and protective factors assessed with the German version of the Parenting-Stress-Index (EBI) | German version of the Parenting-Stress-Index (EBI) | up to 3 years | 
| Social network assessed with the Social Network Scales | Social Network Scales | up to 10 years | 
| Parental self-efficacy assessed with the Self-Efficacy in Infant Care Scale (SICS) | Self-Efficacy in Infant Care Scale (SICS) | up to 4 years | 
| Parental self-efficacy assessed with the Parenting Sense of Competence Scale (PSOC) | Parenting Sense of Competence Scale (PSOC) | up to 3 years | 
| Parental depressivity assessed with the subscale of the Brief Symptom Inventory (BSI) | Depressive symptoms (subscale BSI) | up to 6 years | 
| Educational attitudes assessed with the German test Educational Attitudes Scale (EMKK) | German Educational Attitudes Scale (EMKK) | up to 4 years | 
| Parenting assessed with the Alabama Parenting Questionnaire (APQ) | Alabama Parenting Questionnaire (APQ) | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early intervention, ECCE, Intervention study, Child development, At-risk families, Psychosocial stress, Prevention, Educational opportunities, Randomized controlled trial, Evaluation, Parenting, Parent-child interaction