Quality of LifeNCT02148419
Psychosocial Development of Maltreated Children: A Prospective Study
An observational study of Quality of Life, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 15 years
- Conditions the study is for
- Quality of Life
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Jan 2017
- Phase
- Observational
- 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 1 day to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Inpatients
- Outpatients
- Sexual abuse
- Physical maltreatment
- Psychological maltreatment
- Neglect
Show all 9Show fewer
- Substantiated maltreatment
- Indicated maltreatment
- Aged 0-15 years at recruitment
Who cannot join
- telephone counseling
- Munchausen Syndrome by proxy
- Maltreatment not confirmed
- Aged 16 years and older at recruitment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital
Zurich, Canton of Zurich, 8032
About this study
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.
Read the 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).
- Conditions
- Quality of Life
- Being tested
- no intervention
- Keywords
- quality of life, maltreatment, neglect, childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: recruiting not successful, too few participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Baden
- Responsible party
- Principal investigator, Andreas Jud,PhD, University Children's Hospital, Zurich
- Investigators
- Andreas Jud, Dr., Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148419
- Sponsor's protocol ID
- KEK-ZH-Nr. 2013-0331
- Status last verified
- Feb 2017
- First submitted
- 13 May 2014
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Development of Maltreated Children: A Prospective Study
- ClinicalTrials.gov ID
- NCT02148419
- Acronym / sponsor ID
- KEK-ZH-Nr. 2013-0331
- Conditions
- Quality of Life
- Keywords
- quality of life, maltreatment, neglect, childhood
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruiting not successful, too few participants
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- Kantonsspital Baden
- Study start
- Feb 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (9 listed)
- Inpatients
- Outpatients
- Sexual abuse
- Physical maltreatment
- Psychological maltreatment
Key exclusion criteria (4 listed)
- telephone counseling
- Munchausen Syndrome by proxy
- Maltreatment not confirmed
- Aged 16 years and older at recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | – |
Primary outcome
Psychosocial development
Time frame: Four years
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.)
Results and safety
The study was stopped early (reason given: recruiting not successful, too few participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Jud, Dr. principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by University Children's Hospital, Zurich 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 9 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: stopped early, as of the sponsor's last update on 9 Feb 2017. 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?
The study was stopped early (reason given: recruiting not successful, too few participants). 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?
Psychosocial development (time frame: Four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2017.