Early Support From Birth Onwards: ZEPPELIN

NCT02882763 | Unknown DMC

• 1 other identifier: ZEP_0-3_FU
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (8)

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

  up to 8 years

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

  up to 3 years

• Social network assessed with the Social Network Scales

  up to 10 years

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

  up to 4 years

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

  up to 3 years

Other Outcomes (5)

• Chronic biological stress assessed with nail cortisol concentrations (NCC)

  up to 6 years

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

  up to 6 years

• Self-control assessed with the Watch-and-Wait Task

  up to 7 years

Study Arms (2)

Parents As Teachers (PAT)

EXPERIMENTAL

c.f. intervention

Other: Parents As Teachers (PAT)

control group condition

NO INTERVENTION

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

Parents As Teachers (PAT) OTHER

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.

Parents As Teachers (PAT)

Eligibility Criteria

• Age: Up to 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Applied Sciences of Special Needs Education

Zurich, 8050, Switzerland

Location

Related Publications (11)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Lanfranchi A, Neuhauser A. ZEPPELIN 0-3 - Förderung ab Geburt mit "PAT - Mit Eltern lernen". Sonderpädagogische Förderung heute, 56 (4): 437 - 442, 2011.

  BACKGROUND

• Lanfranchi A, Sindbert R. Das Förderprogramm PAT-Mit Eltern Lernen - Eltern-Kind-Konzepte auf den Punkt gebracht. Frühförderung interdisziplinär, 32(2), 108-112, 2013.

  BACKGROUND

• Templer F, Lanfranchi A, Neuhauser A. ZEPPELIN 0-3: Frühe Förderung ab Geburt mit dem Programm

  BACKGROUND

• Lanfranchi A. Frühkindliche selektive Prävention bei Kindern aus Familien in Risikosituationen - Stigmatisierungsgefahren und Entwicklungschancen. Familiendynamik, 39(3), 188-199, 2014.

  BACKGROUND

• Lanfranchi A, Sempert W. Wirkung frühkindlicher Betreuung auf den Schulerfolg Follow-up der Nationalfonds-Studie "Schulerfolg von Migrationskindern". Bern: Edition SZH, 2012.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  RESULT

• Neuhauser A. Predictors of maternal sensitivity in at-risk families. Early Child Development and Care (in press), 2016.

  RESULT

Study Officials

• Alex Neuhauser, lic. phil.

  University of Applied Sciences of Special Needs Education

  PRINCIPAL INVESTIGATOR

• Andrea Lanfranchi, Prof. Dr.

  University of Applied Sciences of Special Needs Education

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 30, 2016
• Study Start: September 1, 2011
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 5, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)