Early Intervention (Education) Clinical Trial
— ZEPPELINOfficial title:
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.
| Status | Active, not recruiting |
| Enrollment | 213 |
| Est. completion date | July 2021 |
| Est. primary completion date | July 2021 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 9 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University of Applied Sciences of Special Needs Education | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Applied Sciences of Special Needs Education | Bundesamt für Migration (BFM), Ernst Göhner Stiftung, Jacobs Foundation, Lotteriefonds des Kantons Zürich, Paul Schiller Stiftung, Schweizerische UNESCO-Kommission, Stiftung Mercator Schweiz, Swiss National Science Foundation, University of Zurich, Vontobel-Stiftung |
Switzerland,
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.
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, Neuhauser A. ZEPPELIN 0-3: Theoretische Grundlagen, Konzept und Implementation des frühkindlichen Förderprogramms "PAT -Mit Eltern Lernen". Frühe Bildung 2(1): 3-11, 2013.
Lanfranchi A, Sempert W. Wirkung frühkindlicher Betreuung auf den Schulerfolg Follow-up der Nationalfonds-Studie "Schulerfolg von Migrationskindern". Bern: Edition SZH, 2012.
Lanfranchi A, Sindbert R. Das Förderprogramm PAT-Mit Eltern Lernen - Eltern-Kind-Konzepte auf den Punkt gebracht. Frühförderung interdisziplinär, 32(2), 108-112, 2013.
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. Frühkindliche selektive Prävention bei Kindern aus Familien in Risikosituationen - Stigmatisierungsgefahren und Entwicklungschancen. Familiendynamik, 39(3), 188-199, 2014.
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.
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.
Templer F, Lanfranchi A, Neuhauser A. ZEPPELIN 0-3: Frühe Förderung ab Geburt mit dem Programm
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Chronic biological stress assessed with nail cortisol concentrations (NCC) | Nail cortisol concentrations (NCC) | up to 6 years | No |
| Other | 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 | No |
| Other | Self-control assessed with the Watch-and-Wait Task | Watch-and-Wait Task | up to 7 years | No |
| Other | Dental health assessed with a Dental examination | Dental examination | up to 6 years | No |
| Other | 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 | No |
| Primary | 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 | No |
| Primary | Child development assessed with the Snijders-Oomen nonverbal intelligence test (SON-R) | Snijders-Oomen nonverbal intelligence test (SON-R) | up to 7 years | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | Mathematical skills assessed with the TEDI-MATH test | Mathematical skills (TEDI-MATH) | up to 5 years | No |
| Primary | Language skills assessed with the German test "Linguistically Competent" | "Linguistically Competent" | up to 5 years | No |
| Primary | Child Health assessed with the Health questionnaire | Health questionnaire | up to 9 years | No |
| Primary | Child Behavior assessed with the Child Behaviour Checklist (CBCL) | Child Behaviour Checklist (CBCL) | up to 6 years | No |
| Primary | Child Behavior assessed with the Strengths and Difficulties Questionnaire (SDQ) | Strengths and Difficulties Questionnaire (SDQ) | up to 5 years | No |
| Primary | Parent-child interaction assessed with the Child-Adult-Relationship-Experimental Index (CARE-Index) | Child-Adult-Relationship-Experimental Index (CARE-Index) | up to 4 years | No |
| Primary | Parent-child interaction assessed with the Emotional Availability (EA) Scales | Emotional Availability (EA) Scales | up to 3 years | No |
| Primary | Home environment assessed with the Home Observation Measurement of the Environment (HOME) | Home Observation Measurement of the Environment (HOME) | up to 7 years | No |
| Secondary | Risk and protective factors assessed with the Heidelberg Stress Scale (HBS) | Heidelberg Stress Scale (HBS) | up to 8 years | No |
| Secondary | 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 | No |
| Secondary | Social network assessed with the Social Network Scales | Social Network Scales | up to 10 years | No |
| Secondary | Parental self-efficacy assessed with the Self-Efficacy in Infant Care Scale (SICS) | Self-Efficacy in Infant Care Scale (SICS) | up to 4 years | No |
| Secondary | Parental self-efficacy assessed with the Parenting Sense of Competence Scale (PSOC) | Parenting Sense of Competence Scale (PSOC) | up to 3 years | No |
| Secondary | Parental depressivity assessed with the subscale of the Brief Symptom Inventory (BSI) | Depressive symptoms (subscale BSI) | up to 6 years | No |
| Secondary | Educational attitudes assessed with the German test Educational Attitudes Scale (EMKK) | German "Educational Attitudes Scale" (EMKK) | up to 4 years | No |
| Secondary | Parenting assessed with the Alabama Parenting Questionnaire (APQ) | Alabama Parenting Questionnaire (APQ) | up to 3 years | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03820011 -
Participation and Environment Measure-Plus (PEM-Plus) Care Planning Intervention
|
N/A |