Clinical trial NCT02882763: Early Support From Birth Onwards: ZEPPELIN
Official title: Zurich Equity Prevention Project Parental Participation and Integration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of Applied Sciences of Special Needs Education
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Jacobs Foundation
name: Stiftung Mercator Schweiz
name: Ernst Göhner Stiftung
name: Paul Schiller Stiftung
name: Vontobel-Stiftung
name: Lotteriefonds des Kantons Zürich
name: Bundesamt für Migration (BFM)
name: Schweizerische UNESCO-Kommission
name: University of Zurich
First posted: 2016-08-30
Enrollment: 213
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child development assessed with the Bayley Scale of Infant and Toddler Development (BSID III)
timeFrame: up to 3 years
measure: Child development assessed with the Snijders-Oomen nonverbal intelligence test (SON-R)
timeFrame: up to 7 years
measure: Child development assessed with the Developmental Observation Scales (EBD 48-72)
timeFrame: up to 1 year
measure: Language skills assessed with the Language Evaluation Short form SBE-2-KT; SBE-3-KT)
timeFrame: up to 3 years
measure: Mathematical skills assessed with the TEDI-MATH test
timeFrame: up to 5 years
measure: Language skills assessed with the German test "Linguistically Competent"
timeFrame: up to 5 years
measure: Child Health assessed with the Health questionnaire
timeFrame: up to 9 years
measure: Child Behavior assessed with the Child Behaviour Checklist (CBCL)
timeFrame: up to 6 years
measure: Child Behavior assessed with the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: up to 5 years
measure: Parent-child interaction assessed with the Child-Adult-Relationship-Experimental Index (CARE-Index)
timeFrame: up to 4 years
measure: Parent-child interaction assessed with the Emotional Availability (EA) Scales
timeFrame: up to 3 years
measure: Home environment assessed with the Home Observation Measurement of the Environment (HOME)
timeFrame: up to 7 years
Secondary outcomes:
measure: Risk and protective factors assessed with the Heidelberg Stress Scale (HBS)
timeFrame: up to 8 years
measure: Risk and protective factors assessed with the German version of the Parenting-Stress-Index (EBI)
timeFrame: up to 3 years
measure: Social network assessed with the Social Network Scales
timeFrame: up to 10 years
measure: Parental self-efficacy assessed with the Self-Efficacy in Infant Care Scale (SICS)
timeFrame: up to 4 years
measure: Parental self-efficacy assessed with the Parenting Sense of Competence Scale (PSOC)
timeFrame: up to 3 years
measure: Parental depressivity assessed with the subscale of the Brief Symptom Inventory (BSI)
timeFrame: up to 6 years
measure: Educational attitudes assessed with the German test Educational Attitudes Scale (EMKK)
timeFrame: up to 4 years
measure: Parenting assessed with the Alabama Parenting Questionnaire (APQ)
timeFrame: up to 3 years
Other outcomes:
measure: Chronic biological stress assessed with nail cortisol concentrations (NCC)
timeFrame: up to 6 years
measure: Chronic biological stress assessed with methylation in the FK506 binding protein 5 (FKBP5) gene
timeFrame: up to 6 years
measure: Self-control assessed with the Watch-and-Wait Task
timeFrame: up to 7 years
measure: Dental health assessed with a Dental examination
timeFrame: up to 6 years
measure: Chronic biological stress assessed with methylation in the nuclear receptor subfamily 3 group C member 1 (NR3C1) gene
timeFrame: up to 6 years
Locations:
city: Zurich
country: Switzerland
facility: University of Applied Sciences of Special Needs Education
Study officials:
affiliation: University of Applied Sciences of Special Needs Education
name: Alex Neuhauser, lic. phil.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Applied Sciences of Special Needs Education
name: Andrea Lanfranchi, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: Lanfranchi A, Neuhauser A. ZEPPELIN 0-3 - Förderung ab Geburt mit "PAT - Mit Eltern lernen". Sonderpädagogische Förderung heute, 56 (4): 437 - 442, 2011.
citation: Lanfranchi A, Sindbert R. Das Förderprogramm PAT-Mit Eltern Lernen - Eltern-Kind-Konzepte auf den Punkt gebracht. Frühförderung interdisziplinär, 32(2), 108-112, 2013.
citation: Templer F, Lanfranchi A, Neuhauser A. ZEPPELIN 0-3: Frühe Förderung ab Geburt mit dem Programm
citation: Lanfranchi A. Frühkindliche selektive Prävention bei Kindern aus Familien in Risikosituationen - Stigmatisierungsgefahren und Entwicklungschancen. Familiendynamik, 39(3), 188-199, 2014.
citation: Lanfranchi A, Sempert W. Wirkung frühkindlicher Betreuung auf den Schulerfolg Follow-up der Nationalfonds-Studie "Schulerfolg von Migrationskindern". Bern: Edition SZH, 2012.
citation: 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.
citation: 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.
citation: 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.
citation: Neuhauser A. Predictors of maternal sensitivity in at-risk families. Early Child Development and Care (in press), 2016.