Early Support From Birth Onwards: ZEPPELIN (ZEPPELIN)

Zurich Equity Prevention Project Parental Participation and Integration

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.

Study Overview

• Status: Unknown
• Conditions: Early Intervention (Education)
• Intervention / Treatment: Other: Parents As Teachers (PAT)

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.

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parents As Teachers (PAT); c.f. intervention	Other: Parents 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.
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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic biological stress assessed with nail cortisol concentrations (NCC)	Nail cortisol concentrations (NCC)	up to 6 years
Chronic biological stress assessed with methylation in the FK506 binding protein 5 (FKBP5) gene	Methylation in the FK506 binding protein 5 (FKBP5) gene	up to 6 years
Self-control assessed with the Watch-and-Wait Task	Watch-and-Wait Task	up to 7 years
Dental health assessed with a Dental examination	Dental examination	up to 6 years
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	up to 6 years

Collaborators and Investigators

• Sponsor: University of Applied Sciences of Special Needs Education
• Collaborators: University of Zurich; 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
• Investigators: Principal Investigator: Alex Neuhauser, lic. phil., University of Applied Sciences of Special Needs Education; Study Chair: Andrea Lanfranchi, Prof. Dr., University of Applied Sciences of Special Needs Education

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Estimate): September 5, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Evaluation; Prevention; Early intervention; Parenting; Child development; Intervention study; ECCE; At-risk families; Psychosocial stress; Educational opportunities; Parent-child interaction
• Other Study ID Numbers: ZEP_0-3_FU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: After summer 2017 at the Swiss Centre of Expertise in the Social Sciences (FORS)