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Status unknownNCT02882763ZEPPELINUpdated Sep 5, 2016

Early Support From Birth Onwards: ZEPPELIN

An interventional study of Parents As Teachers (PAT) in Early Intervention (Education), sponsored by University of Applied Sciences of Special Needs Education. Status unknown at 1 site in Switzerland. Open to participants aged Up to 9 Years. Per ClinicalTrials.gov, last updated 2016-09-05.

Sponsored by University of Applied Sciences of Special Needs Education · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
213
Allocation
Randomized
Ages
Up to 9 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • 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
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In context

Lead sponsor

This is the only study on the registry with University of Applied Sciences of Special Needs Education as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 9 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
213 participants (actual)

Study arms

  • Experimental
    Parents As Teachers (PAT)

    c.f. intervention

    Other: Parents As Teachers (PAT)

  • No intervention
    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.

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.

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What researchers measure

Primary outcomes

  1. Child development assessed with the Bayley Scale of Infant and Toddler Development (BSID III)

    Bayley Scale of Infant and Toddler Development (BSID III)

    Time frame: up to 3 years

  2. Child development assessed with the Snijders-Oomen nonverbal intelligence test (SON-R)

    Snijders-Oomen nonverbal intelligence test (SON-R)

    Time frame: up to 7 years

  3. Child development assessed with the Developmental Observation Scales (EBD 48-72)

    German Developmental Observation Scales for child care centers (EBD 48-72)

    Time frame: up to 1 year

  4. 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)

    Time frame: up to 3 years

  5. Mathematical skills assessed with the TEDI-MATH test

    Mathematical skills (TEDI-MATH)

    Time frame: up to 5 years

  6. Language skills assessed with the German test "Linguistically Competent"

    "Linguistically Competent"

    Time frame: up to 5 years

  7. Child Health assessed with the Health questionnaire

    Health questionnaire

    Time frame: up to 9 years

  8. Child Behavior assessed with the Child Behaviour Checklist (CBCL)

    Child Behaviour Checklist (CBCL)

    Time frame: up to 6 years

  9. Child Behavior assessed with the Strengths and Difficulties Questionnaire (SDQ)

    Strengths and Difficulties Questionnaire (SDQ)

    Time frame: up to 5 years

  10. Parent-child interaction assessed with the Child-Adult-Relationship-Experimental Index (CARE-Index)

    Child-Adult-Relationship-Experimental Index (CARE-Index)

    Time frame: up to 4 years

  11. Parent-child interaction assessed with the Emotional Availability (EA) Scales

    Emotional Availability (EA) Scales

    Time frame: up to 3 years

  12. Home environment assessed with the Home Observation Measurement of the Environment (HOME)

    Home Observation Measurement of the Environment (HOME)

    Time frame: up to 7 years

Secondary outcomes

  1. Risk and protective factors assessed with the Heidelberg Stress Scale (HBS)

    Heidelberg Stress Scale (HBS)

    Time frame: up to 8 years

  2. Risk and protective factors assessed with the German version of the Parenting-Stress-Index (EBI)

    German version of the Parenting-Stress-Index (EBI)

    Time frame: up to 3 years

  3. Social network assessed with the Social Network Scales

    Social Network Scales

    Time frame: up to 10 years

  4. Parental self-efficacy assessed with the Self-Efficacy in Infant Care Scale (SICS)

    Self-Efficacy in Infant Care Scale (SICS)

    Time frame: up to 4 years

  5. Parental self-efficacy assessed with the Parenting Sense of Competence Scale (PSOC)

    Parenting Sense of Competence Scale (PSOC)

    Time frame: up to 3 years

  6. Parental depressivity assessed with the subscale of the Brief Symptom Inventory (BSI)

    Depressive symptoms (subscale BSI)

    Time frame: up to 6 years

  7. Educational attitudes assessed with the German test Educational Attitudes Scale (EMKK)

    German "Educational Attitudes Scale" (EMKK)

    Time frame: up to 4 years

  8. Parenting assessed with the Alabama Parenting Questionnaire (APQ)

    Alabama Parenting Questionnaire (APQ)

    Time frame: up to 3 years

Other outcomes

  1. Chronic biological stress assessed with nail cortisol concentrations (NCC)

    Nail cortisol concentrations (NCC)

    Time frame: up to 6 years

  2. Chronic biological stress assessed with methylation in the FK506 binding protein 5 (FKBP5) gene

    Methylation in the FK506 binding protein 5 (FKBP5) gene

    Time frame: up to 6 years

  3. Self-control assessed with the Watch-and-Wait Task

    Watch-and-Wait Task

    Time frame: up to 7 years

  4. Dental health assessed with a Dental examination

    Dental examination

    Time frame: up to 6 years

  5. Chronic biological stress assessed with methylation in the nuclear receptor subfamily 3 group C member 1 (NR3C1) gene

    methylation in the nuclear receptor subfamily 3 group C member 1 (NR3C1) gene

    Time frame: up to 6 years

07

Study locations

1 site
  • University of Applied Sciences of Special Needs Education
    Zurich, 8050, Switzerland
08

References and documents

Publications

  • Lanfranchi A, Neuhauser A. ZEPPELIN 0-3: Theoretische Grundlagen, Konzept und Implementation des frühkindlichen Förderprogramms "PAT -Mit Eltern Lernen". Frühe Bildung 2(1): 3-11, 2013.
  • Neuhauser, A. A closer look at the effectiveness of early childhood education in at-risk families. Mental Health and Prevention 2(3-4): 43-57, 2014.
  • Lanfranchi A, Neuhauser A. ZEPPELIN 0-3 - Förderung ab Geburt mit "PAT - Mit Eltern lernen". Sonderpädagogische Förderung heute, 56 (4): 437 - 442, 2011.
  • Lanfranchi A, Sindbert R. Das Förderprogramm PAT-Mit Eltern Lernen - Eltern-Kind-Konzepte auf den Punkt gebracht. Frühförderung interdisziplinär, 32(2), 108-112, 2013.
  • Templer F, Lanfranchi A, Neuhauser A. ZEPPELIN 0-3: Frühe Förderung ab Geburt mit dem Programm
  • Lanfranchi A. Frühkindliche selektive Prävention bei Kindern aus Familien in Risikosituationen - Stigmatisierungsgefahren und Entwicklungschancen. Familiendynamik, 39(3), 188-199, 2014.
  • Lanfranchi A, Sempert W. Wirkung frühkindlicher Betreuung auf den Schulerfolg Follow-up der Nationalfonds-Studie "Schulerfolg von Migrationskindern". Bern: Edition SZH, 2012.
  • Lanfranchi A. Familienergänzende Betreuung. In M. Stamm & D. Edelmann (Eds.), Frühkindliche Bildung, Betreuung und Erziehung: Was kann die Schweiz lernen? (S. 97-121). Bern: Haupt, 2010.
  • Lanfranchi A, Burgener Woeffray A. Familien in Risikosituationen durch frühkindliche Bildung erreichen. In M. Stamm & D. Edelmann (Eds.), Handbuch Frühkindliche Bildungsforschung (S. 603-616). Wiesbaden: VS/ Springer, 2013.
  • Neuhauser A, Ramseier E, Schaub S, Burkhardt SCA, Templer F, Lanfranchi A. Hard to reach families - a methodological approach for early detection, recruitment, and randomization in an intervention study. Mental Health and Prevention, 3, 79-88, 2015.
  • Neuhauser A. Predictors of maternal sensitivity in at-risk families. Early Child Development and Care (in press), 2016.

Individual participant data

Plan to share: Yes — After summer 2017 at the Swiss Centre of Expertise in the Social Sciences (FORS)

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02882763
Lead sponsor
University of Applied Sciences of Special Needs Education
Collaborators
Swiss National Science Foundation, Jacobs Foundation, Stiftung Mercator Schweiz, Ernst Göhner Stiftung, Paul Schiller Stiftung, Vontobel-Stiftung, Lotteriefonds des Kantons Zürich, Bundesamt für Migration (BFM), Schweizerische UNESCO-Kommission, University of Zurich
Responsible party
Sponsor
First posted
Aug 30, 2016
Start date
Sep 2011
Primary completion
Jul 2021 (estimated)
Completion
Jul 2021 (estimated)
Last update
Sep 5, 2016

Study contacts

Alex Neuhauser, lic. phil.
principal investigator · University of Applied Sciences of Special Needs Education
Andrea Lanfranchi, Prof. Dr.
study chair · University of Applied Sciences of Special Needs Education

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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