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Early Support From Birth Onwards: ZEPPELIN

Zurich Equity Prevention Project Parental Participation and Integration

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02882763
Acronym
ZEPPELIN
Enrollment
213
Registered
2016-08-30
Start date
2011-09-30
Completion date
2021-07-31
Last updated
2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Intervention (Education)

Keywords

Early intervention, ECCE, Intervention study, Child development, At-risk families, Psychosocial stress, Prevention, Educational opportunities, Randomized controlled trial, Evaluation, Parenting, Parent-child interaction

Brief summary

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: 1. Identification of children at risk at an early age, using an interdisciplinary network; 2. Investigation of the acceptability of the program by the parents; 3. Evaluation of the intervention process and efficacy during and immediately after program implementation; 4. Evaluation of the efficacy in terms of child academic performance.

Detailed description

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: 1. Identification of children at risk at an early age, using an interdisciplinary network; 2. Investigation of the acceptability of the program in parents; 3. Evaluation of the intervention process and efficacy during and immediately after program implementation; 4. 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.

Interventions

OTHERParents As Teachers (PAT)

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.

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
Jacobs Foundation
CollaboratorUNKNOWN
Stiftung Mercator Schweiz
CollaboratorUNKNOWN
Ernst Göhner Stiftung
CollaboratorUNKNOWN
Paul Schiller Stiftung
CollaboratorUNKNOWN
Vontobel-Stiftung
CollaboratorUNKNOWN
Lotteriefonds des Kantons Zürich
CollaboratorUNKNOWN
Bundesamt für Migration (BFM)
CollaboratorUNKNOWN
Schweizerische UNESCO-Kommission
CollaboratorUNKNOWN
University of Zurich
CollaboratorOTHER
University of Applied Sciences of Special Needs Education
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Child Behavior assessed with the Child Behaviour Checklist (CBCL)up to 6 yearsChild Behaviour Checklist (CBCL)
Child development assessed with the Bayley Scale of Infant and Toddler Development (BSID III)up to 3 yearsBayley Scale of Infant and Toddler Development (BSID III)
Child development assessed with the Snijders-Oomen nonverbal intelligence test (SON-R)up to 7 yearsSnijders-Oomen nonverbal intelligence test (SON-R)
Child development assessed with the Developmental Observation Scales (EBD 48-72)up to 1 yearGerman Developmental Observation Scales for child care centers (EBD 48-72)
Language skills assessed with the Language Evaluation Short form SBE-2-KT; SBE-3-KT)up to 3 yearsLanguage evaluation short form (SBE-2-KT; SBE-3-KT)
Mathematical skills assessed with the TEDI-MATH testup to 5 yearsMathematical skills (TEDI-MATH)
Language skills assessed with the German test Linguistically Competentup to 5 yearsLinguistically Competent
Child Health assessed with the Health questionnaireup to 9 yearsHealth questionnaire
Child Behavior assessed with the Strengths and Difficulties Questionnaire (SDQ)up to 5 yearsStrengths and Difficulties Questionnaire (SDQ)
Home environment assessed with the Home Observation Measurement of the Environment (HOME)up to 7 yearsHome Observation Measurement of the Environment (HOME)
Parent-child interaction assessed with the Emotional Availability (EA) Scalesup to 3 yearsEmotional Availability (EA) Scales
Parent-child interaction assessed with the Child-Adult-Relationship-Experimental Index (CARE-Index)up to 4 yearsChild-Adult-Relationship-Experimental Index (CARE-Index)

Secondary

MeasureTime frameDescription
Parenting assessed with the Alabama Parenting Questionnaire (APQ)up to 3 yearsAlabama Parenting Questionnaire (APQ)
Risk and protective factors assessed with the Heidelberg Stress Scale (HBS)up to 8 yearsHeidelberg Stress Scale (HBS)
Risk and protective factors assessed with the German version of the Parenting-Stress-Index (EBI)up to 3 yearsGerman version of the Parenting-Stress-Index (EBI)
Social network assessed with the Social Network Scalesup to 10 yearsSocial Network Scales
Parental self-efficacy assessed with the Self-Efficacy in Infant Care Scale (SICS)up to 4 yearsSelf-Efficacy in Infant Care Scale (SICS)
Parental self-efficacy assessed with the Parenting Sense of Competence Scale (PSOC)up to 3 yearsParenting Sense of Competence Scale (PSOC)
Parental depressivity assessed with the subscale of the Brief Symptom Inventory (BSI)up to 6 yearsDepressive symptoms (subscale BSI)
Educational attitudes assessed with the German test Educational Attitudes Scale (EMKK)up to 4 yearsGerman Educational Attitudes Scale (EMKK)

Other

MeasureTime frameDescription
Chronic biological stress assessed with nail cortisol concentrations (NCC)up to 6 yearsNail cortisol concentrations (NCC)
Chronic biological stress assessed with methylation in the nuclear receptor subfamily 3 group C member 1 (NR3C1) geneup to 6 yearsmethylation in the nuclear receptor subfamily 3 group C member 1 (NR3C1) gene
Dental health assessed with a Dental examinationup to 6 yearsDental examination
Self-control assessed with the Watch-and-Wait Taskup to 7 yearsWatch-and-Wait Task
Chronic biological stress assessed with methylation in the FK506 binding protein 5 (FKBP5) geneup to 6 yearsMethylation in the FK506 binding protein 5 (FKBP5) gene

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026