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Early Intervention (Education)ZEPPELINNCT02882763

Early Support From Birth Onwards: ZEPPELIN

A study testing Parents As Teachers (PAT) in people with Early Intervention (Education), run by University of Applied Sciences of Special Needs Education at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 9 years
Conditions the study is for
Early Intervention (Education)
What is being tested?
Parents As Teachers (PAT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
1 siteSwitzerland
Study dates
Sep 2011to Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of Applied Sciences of Special Needs Education

    Zurich, 8050

Other trials in Switzerland

About this study

Official 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.
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.

Being tested
Parents As Teachers (PAT)
Keywords
Early intervention, ECCE, Intervention study, Child development, At-risk families, Psychosocial stress, Prevention, Educational opportunities, Randomized controlled trial, Evaluation, Parenting, Parent-child interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02882763
Study groupRoleWhat they receive
Parents As Teachers (PAT)Experimentalc.f. intervention
Receives: Other: Parents As Teachers (PAT)
control group conditionNo interventionFamilies 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 being measured

The primary outcome is the main question the study is designed to answer.

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

    Bayley Scale of Infant and Toddler Development (BSID III)

    Measured: up to 3 years

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

    Snijders-Oomen nonverbal intelligence test (SON-R)

    Measured: 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)

    Measured: 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)

    Measured: up to 3 years

  5. Mathematical skills assessed with the TEDI-MATH test

    Mathematical skills (TEDI-MATH)

    Measured: up to 5 years

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

    "Linguistically Competent"

    Measured: up to 5 years

  7. Child Health assessed with the Health questionnaire

    Health questionnaire

    Measured: up to 9 years

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

    Child Behaviour Checklist (CBCL)

    Measured: up to 6 years

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

    Strengths and Difficulties Questionnaire (SDQ)

    Measured: 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)

    Measured: up to 4 years

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

    Emotional Availability (EA) Scales

    Measured: up to 3 years

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

    Home Observation Measurement of the Environment (HOME)

    Measured: up to 7 years

Secondary outcomes (8)

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

    Heidelberg Stress Scale (HBS)

    Measured: 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)

    Measured: up to 3 years

  3. Social network assessed with the Social Network Scales

    Social Network Scales

    Measured: 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)

    Measured: up to 4 years

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

    Parenting Sense of Competence Scale (PSOC)

    Measured: up to 3 years

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

    Depressive symptoms (subscale BSI)

    Measured: up to 6 years

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

    German "Educational Attitudes Scale" (EMKK)

    Measured: up to 4 years

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

    Alabama Parenting Questionnaire (APQ)

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2016 (estimated)
  2. Study startSep 2011
  3. Primary completionJul 2021 (estimated)
  4. Study completionJul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02882763
Sponsor's protocol ID
ZEP_0-3_FU
Acronym
ZEPPELIN
Status last verified
Sep 2016
First submitted
28 Jul 2016
Last updated
5 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: After summer 2017 at the Swiss Centre of Expertise in the Social Sciences (FORS)

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.

Questions about this trial

What is this clinical trial studying?

A study testing Parents As Teachers (PAT) in people with Early Intervention (Education), run by University of Applied Sciences of Special Needs Education at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child development assessed with the Bayley Scale of Infant and Toddler Development (BSID III) (time frame: up to 3 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02882763, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.

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