Behavior ProblemsKEEPNCT00980512
Community Implementation of KEEP: Fidelity and Generalization of Parenting
A study testing Parent Training in people with Behavior Problems, run by San Diego State University at 1 site in United States.
Trial summary
The primary goal of this study is to examine the fidelity and generalization of parenting effects of the KEEP foster parent training intervention as it is being delivered within a child welfare system of care by a community mental health provider. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problems
- What is being tested?
- Parent Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2014
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any child between ages 5 and 12 in relative or non-relative foster care
Who cannot join
- Only medically fragile children
Trial locations and contacts
1 site in 1 country.
United States1 site
Child and Adolescent Services Research Center
San Diego, California, 92123
About this study
The primary goal of this study is to examine the fidelity and generalization of parenting effects of the KEEP foster parent training intervention as it is being delivered within a child welfare system of care by a community mental health provider.
Read the detailed description
The primary goal of this study is to utilize this opportunity as a real-world platform for addressing three key questions that need to be answered prior to wide-scale implementation of the KEEP intervention. First, do the effects of the KEEP parent training generalize (concurrently) to other children currently in foster and kin intervention homes and lead to reductions in overall levels of behavior problems? Second, does the KEEP intervention continue to have effects after the completion of the intervention and generalize (temporally) to new children who enter the homes of these families at a later point in time? Finally, as the KEEP intervention is being implemented by a community agency in a real-world system of care, can the intervention be delivered and maintained in a manner that preserves the goals and quality of the intervention?
Children in foster care, between the ages of 5 and 12, will be randomly assigned to one of two conditions - the KEEP intervention or a "services as usual" condition. In the KEEP intervention condition, foster and kin caregivers will participate in 16 weekly group meetings. Outcomes to be assessed include child problem behavior (of the focal child and other children in the household), child functioning, parental stress, family functioning, use of mental health services, child placement changes (e.g., reunification with biological parents, move to another foster home), and foster parent retention rates. In addition, for a year following the completion of the intervention, new children entering the home of foster/kin caregiver will be included in the assessments, along with the impact of these additional children on parental stress and family functioning. Finally, several dimensions of intervention fidelity (e.g., facilitator adherence and group engagement) will be assessed and examined in relation to child, family, and system outcomes.
- Conditions
- Behavior Problems
- Being tested
- Parent Training
- Keywords
- behavior problems, parent training, foster care
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent TrainingBehavioural
Also called Parent Management Training
16 weeks of parent training led by trained group facilitator
| Study group | Role | What they receive |
|---|---|---|
| Parent Training | Experimental | Parent Training of foster parents Receives: Behavioral: Parent Training |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in child behavior problems as assessed by the Parent Daily Report (PDR)
Measured: Baseline, 6-months, 12-months, 18-months
Secondary outcomes (1)
Placement Disruptions from Foster Placement
Measured: 6-month, 12-month, 18-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Behavior ProblemsStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Oregon Social Learning Center
- Responsible party
- Principal investigator, Dr. Joseph M. Price, San Diego State University
- Investigators
- Joseph M. Price, Ph.D., Principal investigator, San Diego State University & Child and Adolescent Services Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980512
- Sponsor's protocol ID
- R01MH060195
- Other IDs
- R01MH060195, 2R01MH060195-06A1, DSIR 84-CTP
- Acronym
- KEEP
- Status last verified
- Nov 2014
- First submitted
- 18 Sep 2009
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Chamberlain P, Price J, Leve LD, Laurent H, Landsverk JA, Reid JB. Prevention of behavior problems for children in foster care: outcomes and mediation effects. Prev Sci. 2008 Mar;9(1):17-27. doi: 10.1007/s11121-007-0080-7. Epub 2008 Jan 10.
PubMed 18185995Price JM, Chamberlain P, Landsverk J, Reid JB, Leve LD, Laurent H. Effects of a foster parent training intervention on placement changes of children in foster care. Child Maltreat. 2008 Feb;13(1):64-75. doi: 10.1177/1077559507310612.
PubMed 18174349Chamberlain P, Price J, Reid J, Landsverk J. Cascading implementation of a foster and kinship parent intervention. Child Welfare. 2008;87(5):27-48.
PubMed 19402358
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Implementation of KEEP: Fidelity and Generalization of Parenting
- ClinicalTrials.gov ID
- NCT00980512
- Acronym / sponsor ID
- KEEP / R01MH060195
- Conditions
- Behavior Problems
- Keywords
- behavior problems, parent training, foster care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Oregon Social Learning Center
- Study start
- Sep 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Sep 2009 (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.
The primary goal of this study is to examine the fidelity and generalization of parenting effects of the KEEP foster parent training intervention as it is being delivered within a child welfare system of care by a community mental health provider.
Detailed description
The primary goal of this study is to utilize this opportunity as a real-world platform for addressing three key questions that need to be answered prior to wide-scale implementation of the KEEP intervention. First, do the effects of the KEEP parent training generalize (concurrently) to other children currently in foster and kin intervention homes and lead to reductions in overall levels of behavior problems? Second, does the KEEP intervention continue to have effects after the completion of the intervention and generalize (temporally) to new children who enter the homes of these families at a later point in time? Finally, as the KEEP intervention is being implemented by a community agency in a real-world system of care, can the intervention be delivered and maintained in a manner that preserves the goals and quality of the intervention?
Children in foster care, between the ages of 5 and 12, will be randomly assigned to one of two conditions - the KEEP intervention or a "services as usual" condition. In the KEEP intervention condition, foster and kin caregivers will participate in 16 weekly group meetings. Outcomes to be assessed include child problem behavior (of the focal child and other children in the household), child functioning, parental stress, family functioning, use of mental health services, child placement changes (e.g., reunification with biological parents, move to another foster home), and foster parent retention rates. In addition, for a year following the completion of the intervention, new children entering the home of foster/kin caregiver will be included in the assessments, along with the impact of these additional children on parental stress and family functioning. Finally, several dimensions of intervention fidelity (e.g., facilitator adherence and group engagement) will be assessed and examined in relation to child, family, and system outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Training | Experimental | Behavioral: Parent TrainingParent Training of foster parents |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any child between ages 5 and 12 in relative or non-relative foster care
Key exclusion criteria (1 listed)
- Only medically fragile children
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 |
|---|---|---|
| Parent TrainingAlso: Parent Management Training16 weeks of parent training led by trained group facilitator | Behavioural | Parent Training |
Primary outcome
Reduction in child behavior problems as assessed by the Parent Daily Report (PDR)
Time frame: Baseline, 6-months, 12-months, 18-months
1 secondary outcome
Placement Disruptions from Foster Placement
Time frame: 6-month, 12-month, 18-month
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 18 Nov 2014.
- Background: PubMed 18185995Chamberlain P, Price J, Leve LD, Laurent H, Landsverk JA, Reid JB. Prevention of behavior problems for children in foster care: outcomes and mediation effects. Prev Sci. 2008 Mar;9(1):17-27. doi: 10.1007/s11121-007-0080-7. Epub 2008 Jan 10.
- Background: PubMed 18174349Price JM, Chamberlain P, Landsverk J, Reid JB, Leve LD, Laurent H. Effects of a foster parent training intervention on placement changes of children in foster care. Child Maltreat. 2008 Feb;13(1):64-75. doi: 10.1177/1077559507310612.
- Background: PubMed 19402358Chamberlain P, Price J, Reid J, Landsverk J. Cascading implementation of a foster and kinship parent intervention. Child Welfare. 2008;87(5):27-48.
- Child and Adolescent Services Research CenterLink provided by the sponsor.
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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.
Joseph M. Price, Ph.D. principal investigator
San Diego State University & Child and Adolescent Services Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Training in people with Behavior Problems, run by San Diego State University 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 1 inclusion and 1 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 18 Nov 2014. 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.
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?
Reduction in child behavior problems as assessed by the Parent Daily Report (PDR) (time frame: Baseline, 6-months, 12-months, 18-months). 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 NCT00980512, which also lists 3 linked publications.
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 18 Nov 2014.