NCT02148419

Brief Summary

Between 2007-2010 the Child Protection Team (CPT) at University Children's Hospital Zurich was the first in Europe to follow up the development of maltreated children in a hospital sample . The follow-up took place 2-3 years after the child had been reported to the CPT. As a major result, children's health-related quality of life (HRQoL) had been impaired in maltreated children compared to controls (Jud, Landolt, Tatalias, Lach, \& Lips, 2012). However, this difference only emerged for the self-assessment of HRQoL by children aged 6 years or older .To address limitations, the CPT at University Children's Hospital Zurich and Children's Hospital Baden AG propose a prospective study with a baseline at the time of report to the CPT and a two year follow-up. This study aims at analyzing HRQoL, behavior and mental health of maltreated children prospectively and will be the first to provide data on changes in HRQoL in the aftermath of maltreatment. We assume the following hypotheses:

  • The HRQoL and mental health of children will be impaired following maltreatment even while controlling for others possible predictors of impaired HRQoL and mental health.
  • We assume a dose-response relationship between severity of maltreatment and impaired HRQoL. Multiple maltreatment is hypothesized to have a larger impact then a single type of maltreatment.
  • At baseline, HRQoL scores are hypothesized to be at a markedly low level. We assume a slight increase in HRQoL from baseline to first follow-up, but not a continuing increase to second follow-up.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

2.9 years

First QC Date

May 13, 2014

Last Update Submit

February 7, 2017

Conditions

Keywords

quality of lifemaltreatmentneglectchildhood

Outcome Measures

Primary Outcomes (1)

  • Psychosocial development

    Normed and established instruments will be used for psychosocial assessment of children and caregivers. The assessment of child's development and well-being by primary caregivers will be complemented by child's self-assessment. Instruments: SON-R 2.5-7 (≥2.5 y.) DDST (0-5 years) KIDSCREEN-27 (≥8 y.) SDQ (11-17 y.) UCLA PTSD Index CDI (≥8 y.) CFT 1 (6-9.5 y.) or CFT 20-R (8.5-16 y.)

    Four years

Interventions

Eligibility Criteria

Age1 Day - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The sample is drawn from in- and outpatients reported to CPTs at University Children's Hospital Zurich and Children's Hospital Baden AG between July 2013 and August 2015.

You may qualify if:

  • Inpatients
  • Outpatients
  • Sexual abuse
  • Physical maltreatment
  • Psychological maltreatment
  • Neglect
  • Substantiated maltreatment
  • Indicated maltreatment
  • Aged 0-15 years at recruitment

You may not qualify if:

  • telephone counseling
  • Munchausen Syndrome by proxy
  • Maltreatment not confirmed
  • Aged 16 years and older at recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital

Zurich, Canton of Zurich, 8032, Switzerland

Location

Study Officials

  • Andreas Jud, Dr.

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Andreas Jud

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 28, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations