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Clinical Trials/NCT02882763
NCT02882763UnknownNot Applicable

Zurich Equity Prevention Project Parental Participation and Integration

University of Applied Sciences of Special Needs Education1 site in 1 country213 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
213
Locations
1
Primary Endpoint
Child Behavior assessed with the Child Behaviour Checklist (CBCL)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
— to 9 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Parents As Teachers (PAT)

Experimental

c.f. intervention

Intervention: Parents As Teachers (PAT) (Other)

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.

Outcomes

Primary Outcomes

Child Behavior assessed with the Child Behaviour Checklist (CBCL)

Time Frame: up to 6 years

Child Behaviour Checklist (CBCL)

Child development assessed with the Developmental Observation Scales (EBD 48-72)

Time Frame: up to 1 year

German Developmental Observation Scales for child care centers (EBD 48-72)

Language skills assessed with the German test "Linguistically Competent"

Time Frame: up to 5 years

"Linguistically Competent"

Child Health assessed with the Health questionnaire

Time Frame: up to 9 years

Health questionnaire

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

Time Frame: up to 7 years

Snijders-Oomen nonverbal intelligence test (SON-R)

Parent-child interaction assessed with the Child-Adult-Relationship-Experimental Index (CARE-Index)

Time Frame: up to 4 years

Child-Adult-Relationship-Experimental Index (CARE-Index)

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

Time Frame: up to 7 years

Home Observation Measurement of the Environment (HOME)

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

Time Frame: up to 3 years

Bayley Scale of Infant and Toddler Development (BSID III)

Language skills assessed with the Language Evaluation Short form SBE-2-KT; SBE-3-KT)

Time Frame: up to 3 years

Language evaluation short form (SBE-2-KT; SBE-3-KT)

Mathematical skills assessed with the TEDI-MATH test

Time Frame: up to 5 years

Mathematical skills (TEDI-MATH)

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

Time Frame: up to 5 years

Strengths and Difficulties Questionnaire (SDQ)

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

Time Frame: up to 3 years

Emotional Availability (EA) Scales

Secondary Outcomes

  • Parenting assessed with the Alabama Parenting Questionnaire (APQ)(up to 3 years)
  • Risk and protective factors assessed with the German version of the Parenting-Stress-Index (EBI)(up to 3 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)
  • Parental depressivity assessed with the subscale of the Brief Symptom Inventory (BSI)(up to 6 years)
  • Social network assessed with the Social Network Scales(up to 10 years)
  • Risk and protective factors assessed with the Heidelberg Stress Scale (HBS)(up to 8 years)
  • Educational attitudes assessed with the German test Educational Attitudes Scale (EMKK)(up to 4 years)

Investigators

Sponsor
University of Applied Sciences of Special Needs Education
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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