Child AbuseNCT00809315
Intervention Development and Pilot for Foster Care Youth
A study testing Assessment and Fostering Healthy Futures (FHF) in people with Child Abuse, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to develop, standardize and provide a preliminary test of a novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which consists of therapeutic skills groups and… Read more about this study
- Who is it for?
- Ages 9 to 11 years
- Conditions the study is for
- Child Abuse
- What is being tested?
- Assessment and Fostering Healthy Futures (FHF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to 23 Mar 2017
- 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 9 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All of the 9-11-year-old children court-ordered into out-of-home care (as a result of maltreatment) over the prior year in participating counties, including:
- Youth placed in group homes, foster homes, and with kin
- Youth with significant behavior problems
- Youth who meet criteria for mental health diagnoses or dual diagnosis
- Youth with mild cognitive impairment
Who cannot join
- Youth who reunify before the beginning of the intervention
- Youth with significant cognitive, behavioral, and/or mental health impairment that interfered with either with their ability to benefit from the prevention program or to participate safely
- Youth who were not proficient enough in English to participate
- Youth who lived too far from sites where groups were hel
- When siblings were both eligible, only one sibling was randomly selected to participate in the study, and the other(s) was excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Denver
Aurora, Colorado, 80045
About this study
The purpose of this study is to develop, standardize and provide a preliminary test of a novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which consists of therapeutic skills groups and mentoring, will improve mental health, social, academic and behavioral functioning and reduce youths' initiation of, and participation in, problem behaviors.
Read the detailed description
This R21 application for a 3-year exploratory/development grant for intervention research is designed to develop, standardize and provide a preliminary test of a novel intervention for children, ages 9-11, placed in out-of-home care. Children and adolescents with a history of maltreatment and subsequent placement in foster care are at risk for substantial mental health and behavioral problems of great public health significance. In the prior longitudinal work with children in foster care, the investigators have described the population, examined child welfare system impact, and identified modifiable psychosocial risk and protective factors. These pre-intervention activities, supported by the principal investigator's K01 award, have enabled the investigator to address important methodological issues that have hampered the development of intervention efforts targeting this high-risk population.
Based on this pre-intervention research, feedback from focus group participants, and a review of other efficacious programs for high-risk youth, the investigators propose to design an intervention for preadolescent youth in foster care consisting of three primary components: assessment and advocacy, mentoring, and therapeutic skills groups. The proposed R21 activities include developing the assessment battery and intervention protocol, manualizing the treatment, estimating recruitment and attrition rates, and conducting a small-scale randomized-controlled pilot study of the intervention. The goals of the intervention will be to improve mental health, social, academic and behavioral functioning and to reduce youths' initiation of, and participation in, problem behaviors. The investigators will conduct a preliminary examination of whether these proximal outcomes are moderated by baseline characteristics and/or mediated by the process variables targeted by the intervention. Estimates of effect size will be used to determine the sample size needed for adequate power to conduct a full-scale randomized controlled trial. The pilot study will also focus on issues of feasibility, program uptake, and replicability, and the investigators will modify the assessment battery, protocol, and manuals following the pilot phase and prior to the application for an R01 to conduct a large-scale efficacy trial.
- Conditions
- Child Abuse
- Being tested
- Assessment, Fostering Healthy Futures (FHF)
- Keywords
- Child abuse and neglect, Out-of-home care, Mentoring, Skills groups, Assessment, Functioning as a result of maltreatment and placement in out-of-home care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Cognitive, academic achievement, and mental health screening assessment and report.
Fostering Healthy Futures (FHF)Behavioural
Weekly therapeutic skill groups and mentoring over a 9-month period.
| Study group | Role | What they receive |
|---|---|---|
| Assessment only | Active comparator | Cognitive, academic achievement and mental health screening assessment and report. Receives: Other: Assessment |
| Fostering Healthy Futures (FHF) Assessment + FHF | Experimental | Cognitive, academic achievement and mental health screening assessment and report. Weekly therapeutic skill groups and mentoring over a 9-month period. Receives: Other: Assessment; Behavioral: Fostering Healthy Futures (FHF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources.
Measured: Immediately post-intervention and 6-months post intervention
Secondary outcomes (1)
Evaluation of Problem behaviors, life-course outcomes, placement history, and service system involvement as measured from multiple informants and sources.
Measured: Immediately post-intervention, 6-months post-intervention, 2.5 years post-intervention and possible future timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startAug 2002
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Heather N Taussig, PhD, Principal investigator, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809315
- Sponsor's protocol ID
- 02-0516a
- Other IDs
- R21MH067618
- Status last verified
- Jun 2021
- First submitted
- 16 Dec 2008
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Taussig HN, Culhane SE, Hettleman D. Fostering healthy futures: an innovative preventive intervention for preadolescent youth in out-of-home care. Child Welfare. 2007 Sep-Oct;86(5):113-31.
PubMed 18422051Taussig HN, Culhane SE. Impact of a mentoring and skills group program on mental health outcomes for maltreated children in foster care. Arch Pediatr Adolesc Med. 2010 Aug;164(8):739-46. doi: 10.1001/archpediatrics.2010.124.
PubMed 20679165Taussig HN, Culhane SE, Garrido E, Knudtson MD. RCT of a mentoring and skills group program: placement and permanency outcomes for foster youth. Pediatrics. 2012 Jul;130(1):e33-9. doi: 10.1542/peds.2011-3447. Epub 2012 Jun 11.
PubMed 22689870Taussig HN, Fulginiti A, Racz SJ, Evans R, Cary Katz C. Long-term impact of the Fostering Healthy Futures for Preteens program on suicide-related thoughts and behaviors for youth in out-of-home care: A randomized controlled trial. Am J Community Psychol. 2024 Sep;74(1-2):74-85. doi: 10.1002/ajcp.12745. Epub 2024 Mar 4.
PubMed 38436484Hambrick E, Lee SK, Weiler L, Collins JO, Rhodes T, Taussig H. Engagement in a Preventive Intervention for Preadolescent Children in Foster Care: Considerations for Intervention Design. Child Psychiatry Hum Dev. 2023 Oct;54(5):1373-1385. doi: 10.1007/s10578-022-01341-8. Epub 2022 Mar 18.
PubMed 35303199Taussig HN, Dmitrieva J, Garrido EF, Cooley JL, Crites E. Fostering Healthy Futures Preventive Intervention for Children in Foster Care: Long-term Delinquency Outcomes from a Randomized Controlled Trial. Prev Sci. 2021 Nov;22(8):1120-1133. doi: 10.1007/s11121-021-01235-6. Epub 2021 Apr 27.
PubMed 33905053
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Development and Pilot for Foster Care Youth
- ClinicalTrials.gov ID
- NCT00809315
- Acronym / sponsor ID
- 02-0516a
- Conditions
- Child Abuse
- Keywords
- Child abuse and neglect, Out-of-home care, Mentoring, Skills groups, Assessment, Functioning as a result of maltreatment and placement in out-of-home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect, National Institute of Mental Health (NIMH)
- Study start
- Aug 2002
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 17 Dec 2008 (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 purpose of this study is to develop, standardize and provide a preliminary test of a novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which consists of therapeutic skills groups and mentoring, will improve mental health, social, academic and behavioral functioning and reduce youths' initiation of, and participation in, problem behaviors.
Detailed description
This R21 application for a 3-year exploratory/development grant for intervention research is designed to develop, standardize and provide a preliminary test of a novel intervention for children, ages 9-11, placed in out-of-home care. Children and adolescents with a history of maltreatment and subsequent placement in foster care are at risk for substantial mental health and behavioral problems of great public health significance. In the prior longitudinal work with children in foster care, the investigators have described the population, examined child welfare system impact, and identified modifiable psychosocial risk and protective factors. These pre-intervention activities, supported by the principal investigator's K01 award, have enabled the investigator to address important methodological issues that have hampered the development of intervention efforts targeting this high-risk population.
Based on this pre-intervention research, feedback from focus group participants, and a review of other efficacious programs for high-risk youth, the investigators propose to design an intervention for preadolescent youth in foster care consisting of three primary components: assessment and advocacy, mentoring, and therapeutic skills groups. The proposed R21 activities include developing the assessment battery and intervention protocol, manualizing the treatment, estimating recruitment and attrition rates, and conducting a small-scale randomized-controlled pilot study of the intervention. The goals of the intervention will be to improve mental health, social, academic and behavioral functioning and to reduce youths' initiation of, and participation in, problem behaviors. The investigators will conduct a preliminary examination of whether these proximal outcomes are moderated by baseline characteristics and/or mediated by the process variables targeted by the intervention. Estimates of effect size will be used to determine the sample size needed for adequate power to conduct a full-scale randomized controlled trial. The pilot study will also focus on issues of feasibility, program uptake, and replicability, and the investigators will modify the assessment battery, protocol, and manuals following the pilot phase and prior to the application for an R01 to conduct a large-scale efficacy trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment only | Active comparator | Other: AssessmentCognitive, academic achievement and mental health screening assessment and report. |
| Fostering Healthy Futures (FHF) Assessment + FHF | Experimental | Other: Assessment, Behavioral: Fostering Healthy Futures (FHF)Cognitive, academic achievement and mental health screening assessment and report. Weekly therapeutic skill groups and mentoring over a 9-month period. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- All of the 9-11-year-old children court-ordered into out-of-home care (as a result of maltreatment) over the prior year in participating counties, including:
- Youth placed in group homes, foster homes, and with kin
- Youth with significant behavior problems
- Youth who meet criteria for mental health diagnoses or dual diagnosis
- Youth with mild cognitive impairment
Key exclusion criteria (5 listed)
- Youth who reunify before the beginning of the intervention
- Youth with significant cognitive, behavioral, and/or mental health impairment that interfered with either with their ability to benefit from the prevention program or to participate safely
- Youth who were not proficient enough in English to participate
- Youth who lived too far from sites where groups were hel
- When siblings were both eligible, only one sibling was randomly selected to participate in the study, and the other(s) was excluded
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 |
|---|---|---|
| AssessmentCognitive, academic achievement, and mental health screening assessment and report. | Other | Assessment only, Fostering Healthy Futures (FHF) Assessment + FHF |
| Fostering Healthy Futures (FHF)Weekly therapeutic skill groups and mentoring over a 9-month period. | Behavioural | Fostering Healthy Futures (FHF) Assessment + FHF |
Primary outcome
Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources.
Time frame: Immediately post-intervention and 6-months post intervention
1 secondary outcome
Evaluation of Problem behaviors, life-course outcomes, placement history, and service system involvement as measured from multiple informants and sources.
Time frame: Immediately post-intervention, 6-months post-intervention, 2.5 years post-intervention and possible future timepoints
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 25 Jun 2021.
- Background: PubMed 18422051Taussig HN, Culhane SE, Hettleman D. Fostering healthy futures: an innovative preventive intervention for preadolescent youth in out-of-home care. Child Welfare. 2007 Sep-Oct;86(5):113-31.
- Results publication: PubMed 20679165Taussig HN, Culhane SE. Impact of a mentoring and skills group program on mental health outcomes for maltreated children in foster care. Arch Pediatr Adolesc Med. 2010 Aug;164(8):739-46. doi: 10.1001/archpediatrics.2010.124.
- Results publication: PubMed 22689870Taussig HN, Culhane SE, Garrido E, Knudtson MD. RCT of a mentoring and skills group program: placement and permanency outcomes for foster youth. Pediatrics. 2012 Jul;130(1):e33-9. doi: 10.1542/peds.2011-3447. Epub 2012 Jun 11.
- Derived from this study: PubMed 38436484Taussig HN, Fulginiti A, Racz SJ, Evans R, Cary Katz C. Long-term impact of the Fostering Healthy Futures for Preteens program on suicide-related thoughts and behaviors for youth in out-of-home care: A randomized controlled trial. Am J Community Psychol. 2024 Sep;74(1-2):74-85. doi: 10.1002/ajcp.12745. Epub 2024 Mar 4.
- Derived from this study: PubMed 35303199Hambrick E, Lee SK, Weiler L, Collins JO, Rhodes T, Taussig H. Engagement in a Preventive Intervention for Preadolescent Children in Foster Care: Considerations for Intervention Design. Child Psychiatry Hum Dev. 2023 Oct;54(5):1373-1385. doi: 10.1007/s10578-022-01341-8. Epub 2022 Mar 18.
- Derived from this study: PubMed 33905053Taussig HN, Dmitrieva J, Garrido EF, Cooley JL, Crites E. Fostering Healthy Futures Preventive Intervention for Children in Foster Care: Long-term Delinquency Outcomes from a Randomized Controlled Trial. Prev Sci. 2021 Nov;22(8):1120-1133. doi: 10.1007/s11121-021-01235-6. Epub 2021 Apr 27.
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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.
Heather N Taussig, PhD principal investigator
University of Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment and Fostering Healthy Futures (FHF) in people with Child Abuse, run by University of Colorado, Denver 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 5 inclusion and 5 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 25 Jun 2021. 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?
Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources. (time frame: Immediately post-intervention and 6-months post intervention). 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 NCT00809315, which also lists 6 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 25 Jun 2021.