Clinical trial NCT02148419: Psychosocial Development of Maltreated Children: A Prospective Study
Official title: Psychosocial Development of Maltreated Children: A Prospective Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Quality of Life
Keywords: quality of life
maltreatment
neglect
childhood
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: Kantonsspital Baden
First posted: 2014-05-28
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: 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 (Jud, Lips, \& Landolt, 2010). Out of a total 180 children in the 2005/2006 CPT caseload, 42 children between 2.5 and 16.5 years and their primary caregiver participated (Jud, Lips, et al., 2010). The follow-up took place 2-3 years after the child had been reported to the CPT. Non-CPT reported hospital patients were used as controls, matched for age, gender, nationality, and medical condition. 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 (Jud et al., 2012). The assessment of children's HRQoL by primary caregivers showed no significant differences for maltreated children compared to controls for all age groups. An essential lack of understanding of the child's experiences and beliefs is not only likely to affect the child's HRQoL, but may also contribute to cur-rent and future risk of maltreatment (Jud et al., 2012). Furthermore, maltreated children had increased depression scores and more behavior problems compared to controls. Detailed results can be found in Jud et al. (Jud et al., 2012; Jud, Lips, et al., 2010). To address these 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. Based on a literature review and findings of the previous follow-up study, 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.
* We assume differing trends for outcome variables in the aftermath of maltreatment and intend to analyze if types of trends are associated with clusters of risk and protective factors (cf. Chaffin, Bard, Hecht, \& Silovsky, 2011).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Psychosocial development
timeFrame: Four years
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: University Children's Hospital, Zurich
name: Andreas Jud, Dr.
role: PRINCIPAL_INVESTIGATOR
References: