Domestic Violence ExposurePhase 3NCT00187772
Child-Parent Psychotherapy for Preschooler Witnesses of Domestic Violence Program
A Phase 3 study testing Child-Parent Psychotherapy (CPP) in people with Domestic Violence Exposure, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence Exposure
- What is being tested?
- Child-Parent Psychotherapy (CPP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1996to Sep 2004
- Phase
- Phase 3
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child 3-5 years old
- child exposed to marital violence as confirmed by mother's report on the Conflict Tactics Scale 2 (Straus et al., 1996)
- perpetrator was not living in the home.
Who cannot join
- mother's documented abuse of the target child
- current maternal substance abuse
- homelessness
- maternal mental retardation
- maternal psychosis
- child mental retardation or autistic-spectrum disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Trauma Research Project
San Francisco, California, 94110
About this study
Official title: Preschooler Witnesses of Domestic Violence: A Preventive Intervention Program
This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence.
Read the detailed description
This study examines the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence. Multi-ethnic preschool-mother dyads from diverse socioeconomic backgrounds were randomly assigned to CPP or to a case management plus community referral for individual treatment comparison group. It was hypothesized the children who received CPP treatment would show significantly greater improvement in general symptomatology and in traumatic stress symptoms than those in the comparison group.
There is growing recognition that, contrary to the long-standing assumption that young children are impervious to environmental stresses, preschoolers exposed to violence show increased rates of disturbances in self-regulation and in emotional, social and cognitive functioning (Osofsky, 2004; Pynoos et al., 1999; van der Kolk, 2003). The present study examines the efficacy of a relationship-based treatment approach involving the child and the mother. Dyads were randomly assigned to either the Child-Parent Psychotherapy (CPP) treatment group or to a comparison group that consisted of monthly case management by an experienced Ph.D.-level clinician plus referrals for individual treatment in the community for mothers and child. We hypothesized that Child-Parent Psychotherapy would be more effective in alleviating children's traumatic stress symptoms and behavior problems because it focuses on improving the quality of the child-mother relationship and engages the mother as the child's ally in coping with the trauma. Treatment was offered for 50 weeks.
- Conditions
- Domestic Violence Exposure
- Being tested
- Child-Parent Psychotherapy (CPP)
- Keywords
- domestic violence, preschoolers, trauma, intervention
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child-Parent Psychotherapy (CPP)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Child symptomatology (CBCL)
Traumatic stress symptomatology (DC 0-3 Traumatic Stress Disorder)
Parent-Child Relationship at posttreatment and 6 month follow-up.
Secondary outcomes (2)
Maternal symptomatology (Symptom Checklist Revised and Clinician Administered PTSD Scale)
Child cognitive functioning (WPPSI-R)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 1996
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Domestic Violence ExposureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Alicia F. Lieberman, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187772
- Sponsor's protocol ID
- R21MH059661
- Other IDs
- R21MH059661, IRB #HR 793-12912-06
- Status last verified
- Sep 2013
- First submitted
- 14 Sep 2005
- Last updated
- 19 Sep 2013
- Results posted
- No
Publications
Lieberman AF, Van Horn P, Ippen CG. Toward evidence-based treatment: child-parent psychotherapy with preschoolers exposed to marital violence. J Am Acad Child Adolesc Psychiatry. 2005 Dec;44(12):1241-8. doi: 10.1097/01.chi.0000181047.59702.58.
PubMed 16292115
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preschooler Witnesses of Domestic Violence: A Preventive Intervention Program
- ClinicalTrials.gov ID
- NCT00187772
- Acronym / sponsor ID
- R21MH059661
- Conditions
- Domestic Violence Exposure
- Keywords
- domestic violence, preschoolers, trauma, intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 1996
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 16 Sep 2005 (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.
This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence.
Detailed description
This study examines the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence. Multi-ethnic preschool-mother dyads from diverse socioeconomic backgrounds were randomly assigned to CPP or to a case management plus community referral for individual treatment comparison group. It was hypothesized the children who received CPP treatment would show significantly greater improvement in general symptomatology and in traumatic stress symptoms than those in the comparison group.
There is growing recognition that, contrary to the long-standing assumption that young children are impervious to environmental stresses, preschoolers exposed to violence show increased rates of disturbances in self-regulation and in emotional, social and cognitive functioning (Osofsky, 2004; Pynoos et al., 1999; van der Kolk, 2003). The present study examines the efficacy of a relationship-based treatment approach involving the child and the mother. Dyads were randomly assigned to either the Child-Parent Psychotherapy (CPP) treatment group or to a comparison group that consisted of monthly case management by an experienced Ph.D.-level clinician plus referrals for individual treatment in the community for mothers and child. We hypothesized that Child-Parent Psychotherapy would be more effective in alleviating children's traumatic stress symptoms and behavior problems because it focuses on improving the quality of the child-mother relationship and engages the mother as the child's ally in coping with the trauma. Treatment was offered for 50 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- child 3-5 years old
- child exposed to marital violence as confirmed by mother's report on the Conflict Tactics Scale 2 (Straus et al., 1996)
- perpetrator was not living in the home.
Key exclusion criteria (6 listed)
- mother's documented abuse of the target child
- current maternal substance abuse
- homelessness
- maternal mental retardation
- maternal psychosis
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 |
|---|---|---|
| Child-Parent Psychotherapy (CPP) | Behavioural | – |
Primary outcome
Child symptomatology (CBCL)
Traumatic stress symptomatology (DC 0-3 Traumatic Stress Disorder)
Parent-Child Relationship at posttreatment and 6 month follow-up.
2 secondary outcomes
Maternal symptomatology (Symptom Checklist Revised and Clinician Administered PTSD Scale)
Child cognitive functioning (WPPSI-R)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
- Results publication: PubMed 16292115Lieberman AF, Van Horn P, Ippen CG. Toward evidence-based treatment: child-parent psychotherapy with preschoolers exposed to marital violence. J Am Acad Child Adolesc Psychiatry. 2005 Dec;44(12):1241-8. doi: 10.1097/01.chi.0000181047.59702.58.
Related trials for Domestic Violence Exposure
Not yet recruitingObservational study
Resilience and Recovery After Intimate Partner Violence - Evaluation of the EMBER-IPV Protocol
Intimate Partner Violence, Intimate Partner Violence Against Women
RecruitingObservational study
How a Resilience-Focused Intervention is Perceived by Women Subjected to Domestic Violence
Shame, Intimate Partner Violence
Active, not recruiting
Peer Counselling to Reduce Psychological Distress and Exposure to Violence Among Sexual and Gender Minorities
Mental Health, Psychological Distress
Active, not recruiting
Prevention of Childhood Maltreatment in Families With Young Children
Child Maltreatment, Child Exposure to Intimate Partner Violence
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.
Alicia F. Lieberman, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Child-Parent Psychotherapy (CPP) in people with Domestic Violence Exposure, run by University of California, San Francisco at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 19 Sep 2013. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 symptomatology (CBCL). The study lists 3 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 NCT00187772, which also lists 1 linked publication.
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 19 Sep 2013.