Serious Emotional DisturbancePhase 3FHDPNCT01567969
Family Health and Development Project
A Phase 3 study testing Intensive In-home Child and Adolescent Psychiatric Service and Home-based Child Treatment Coordination in people with Serious Emotional Disturbance, run by Yale University at 1 site in United States.
Trial summary
The Family Health and Development Project (FHDP) is a randomized controlled trial to evaluate the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) intervention, targeting emotionally, behaviorally, and/or psychiatrically disordered children at risk of a psychiatric inpatient… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Serious Emotional Disturbance
- What is being tested?
- Intensive In-home Child and Adolescent Psychiatric Service and Home-based Child Treatment Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Feb 2016
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child has a Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis
- child at risk of psychiatric hospitalization due to serious out-of-control behaviors
- child resides in home of legal guardian, who is primary caregiver
- child insured by Medicaid
- score in the borderline clinical or clinical range on the Externalizing Scale of the Child Behavior Checklist (CBCL)
Who cannot join
- referred to IICAPS by a probation officer
- suffers from an unstable, chronic medical comorbidity
- prior receipt of IICAPS
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Child Study Center
New Haven, Connecticut, 06519
About this study
Official title: Family Health and Development Project: Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) vs. Home-based Child Treatment Coordination (Home-based CTC) for Seriously Emotionally Disturbed Children
The Family Health and Development Project (FHDP) is a randomized controlled trial to evaluate the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) intervention, targeting emotionally, behaviorally, and/or psychiatrically disordered children at risk of a psychiatric inpatient admission and their families. Children and families are randomized to receive IICAPS or Home-based Child Treatment Coordination (Home-based CTC), a home-based case management intervention for coordination of mental health services for children. Approximately 144 children and their families will be enrolled for a 12 month study period. Data will be collected through interviews with the child's parent/legal guardian, and from the child's teacher, the child's school, and the Department of Social Services (claims data). This study will test the hypotheses that children receiving IICAPS will be less likely to exhibit out-of-control behaviors and less likely to experience a psychiatric hospitalization and/or out-of-home placement during and up to six months post-discharge from services.
Read the detailed description
The Family Health and Development Project (FHDP) is a randomized controlled trial to evaluate the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) intervention, targeting emotionally, behaviorally, and/or psychiatrically disordered children at risk of a psychiatric inpatient admission and their families. Children and families are randomized to receive IICAPS or Home-based Child Treatment Coordination (Home-based CTC), a home-based case management intervention for coordination of mental health services for children. Approximately 144 children and their families will be enrolled for a 12 month study period. Each study intervention is six to seven months in duration, with approximately 6 additional months of follow-up.
Data are collected from the identified child's parent/legal guardian during three in-person assessment interviews (at enrollment, at end of study treatment, and at 12-months), and during brief monthly phone interviews. Data are collected on child psychiatric symptoms and behavior, child psychiatric inpatient admissions and other service utilization, parenting practices, and parental problem solving skills. Additional data are collected from the child's teacher (child's behavior at school) and the child's school (days missed, suspensions, expulsions, disciplinary action) at baseline, 6-months, and 12-months. Service utilization data will be collected from the Connecticut Department of Social Services using claims data.
The main study aim is to evaluate the efficacy of IICAPS for youth with serious and pervasive mental health problems that places them at risk for institutional placement, and test the hypotheses that children receiving IICAPS will be less likely to exhibit out-of-control behaviors and less likely to experience a psychiatric hospitalization and/or out-of-home placement during and up to six months post-discharge from services. The second study aim is to evaluate how the efficacy of IICAPS for youth with serious and pervasive mental health problems is achieved, with specific focus on parenting practices, parental problem solving techniques, and parental perception of the child.
- Conditions
- Serious Emotional Disturbance
- Being tested
- Intensive In-home Child and Adolescent Psychiatric Service, Home-based Child Treatment Coordination
- Keywords
- mental health services, child behavior disorders, child psychiatry
- Medical subject headings
- Child Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive In-home Child and Adolescent Psychiatric ServiceBehavioural
A six to seven month intensive intervention provided by a clinical team consisting of a master's-level clinician and a bachelor's-level mental health counselor delivering comprehensive psychiatric and case management services in the child's home. One or both members of the team works with the child and the family three times a week in the home. Delivery of direct and indirect services average 5.5 hours of service per week.
Home-based Child Treatment CoordinationBehavioural
A six to seven month home-based case management service delivered by a master's level clinician. The coordinator meets with the child's parent/legal guardian in the child's home once a month and conducts weekly phone conversations to facilitate referral and access to appropriate mental health services for the child.
| Study group | Role | What they receive |
|---|---|---|
| IICAPS | Experimental | Provision of Intensive In-home Child and Adolescent Psychiatric Service, a six to seven month family-focused in-home psychiatric intervention. Receives: Behavioral: Intensive In-home Child and Adolescent Psychiatric Service |
| Home-based CTC | Active comparator | Provision of Home-based Child Treatment Coordination, a six to seven month child-focused case management service with monthly in-home visits with the child's parent/legal guardian. Receives: Behavioral: Home-based Child Treatment Coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Out-of-control Behavior
Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS). This instrument is administered at baseline and at the end of study treatment (IICAPS or Home-based CTC), at approximately 6 to 7 months post-baseline.
Measured: Baseline up to 7 months post-baseline
Change in Child Out-of-control Behavior
Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS). This instrument is administered at baseline and at the 12 months post-baseline.
Measured: Baseline to 12 months post-baseline
Change in Child Out-of-control Behavior
Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS) monthly from baseline to 12-months post-baseline.
Measured: Up to 12 months post-baseline
Change in Child Psychiatric Inpatient Admissions and Days
Child psychiatric inpatient admissions and days will be collected for the six-months prior to study enrollment, and measured against child psychiatric inpatient admissions and days from baseline to the end of the study treatment intervention (IICAPS or Home-based CTC), at approximately 6 to 7 months post-baseline.
Measured: Baseline (measure of prior 6 months) up to 7 months post-baseline (measuring time since baseline)
Change in Child Psychiatric Inpatient Days and Admissions
Child psychiatric inpatient admissions and days will be collected for the six-months prior to study enrollment, and measured against child psychiatric inpatient admissions and days from baseline to 12 months post-baseline.
Measured: Baseline (measure of 6 months prior) to 12 months post-baseline
Change in Child Out-of-control Behavior
Child out-of-control behavior as measured by the Child Behavior Checklist (CBCL). This instrument is administered at baseline and at the end of study treatment (IICAPS or Home-based CTC), at approximately 6 to 7 months post-baseline.
Measured: Baseline up to 7 months post-baseline
Change in Child Out-of-control Behavior
Child out-of-control behavior as measured by the Child Behavior Checklist (CBCL). This instrument is administered at baseline and at 12 months post-baseline.
Measured: Baseline to 12 months post-baseline
Secondary outcomes (6)
Change in Parenting Practices
Parenting practices will be measured using the Alabama Parenting Questionnaire (APQ)administered at baseline and at the end of the study treatment intervention (IICAPS or Home-based CTC).
Measured: Baseline up to 7 months post-baseline
Change in Parenting Practices
Parenting practices will be measured using the Alabama Parenting Questionnaire (APQ)administered at baseline and at 12-months post-baseline.
Measured: Baseline to 12 months post-baseline
Change in Parental Problem Solving
Parental problem solving will be measured using the Problem Solving subscale of McMaster Family Assessment Device (FAD) administered at baseline and at the end of the study treatment intervention (IICAPS or Home-based CTC).
Measured: Baseline up to 7 months post-baseline
Change in Parental Problem Solving
Parental problem solving will be measured using the Problem Solving subscale of McMaster Family Assessment Device (FAD) administered at baseline and at 12-months post-baseline.
Measured: Baseline to 12 months post-baseline
Change in Parental Perception of their Child
Parental perception of their child will be measured using the Parent Cognition Scale (PCS) administered at baseline and at the end of the study treatment intervention (IICAPS or Home-based CTC).
Measured: Baseline up to 7 months post-baseline
Change in Parental Perception of their Child
Parental perception of their child will be measured using the Parent Cognition Scale (PCS) administered at baseline and at 12-months post-baseline.
Measured: Baseline to 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMay 2011
- Primary completionNov 2015
- Study completionFeb 2016
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 Serious Emotional DisturbanceStudies of the same condition, open and under way.
- More trials run by Yale 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph L. Woolston, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567969
- Sponsor's protocol ID
- 1102008073
- Acronym
- FHDP
- Status last verified
- Oct 2016
- First submitted
- 12 Mar 2012
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Woolston JL, Adnopoz JA, Berkowitz SJ. IICAPS: A Home-Based Psychiatric Treatment for Children and Adolescents. New Haven: Yale University Press, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Health and Development Project: Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) vs. Home-based Child Treatment Coordination (Home-based CTC) for Seriously Emotionally Disturbed Children
- ClinicalTrials.gov ID
- NCT01567969
- Acronym / sponsor ID
- FHDP / 1102008073
- Conditions
- Serious Emotional Disturbance
- Keywords
- mental health services, child behavior disorders, child psychiatry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Mar 2012 (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 Family Health and Development Project (FHDP) is a randomized controlled trial to evaluate the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) intervention, targeting emotionally, behaviorally, and/or psychiatrically disordered children at risk of a psychiatric inpatient admission and their families. Children and families are randomized to receive IICAPS or Home-based Child Treatment Coordination (Home-based CTC), a home-based case management intervention for coordination of mental health services for children. Approximately 144 children and their families will be enrolled for a 12 month study period. Data will be collected through interviews with the child's parent/legal guardian, and from the child's teacher, the child's school, and the Department of Social Services (claims data). This study will test the hypotheses that children receiving IICAPS will be less likely to exhibit out-of-control behaviors and less likely to experience a psychiatric hospitalization and/or out-of-home placement during and up to six months post-discharge from services.
Detailed description
The Family Health and Development Project (FHDP) is a randomized controlled trial to evaluate the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) intervention, targeting emotionally, behaviorally, and/or psychiatrically disordered children at risk of a psychiatric inpatient admission and their families. Children and families are randomized to receive IICAPS or Home-based Child Treatment Coordination (Home-based CTC), a home-based case management intervention for coordination of mental health services for children. Approximately 144 children and their families will be enrolled for a 12 month study period. Each study intervention is six to seven months in duration, with approximately 6 additional months of follow-up.
Data are collected from the identified child's parent/legal guardian during three in-person assessment interviews (at enrollment, at end of study treatment, and at 12-months), and during brief monthly phone interviews. Data are collected on child psychiatric symptoms and behavior, child psychiatric inpatient admissions and other service utilization, parenting practices, and parental problem solving skills. Additional data are collected from the child's teacher (child's behavior at school) and the child's school (days missed, suspensions, expulsions, disciplinary action) at baseline, 6-months, and 12-months. Service utilization data will be collected from the Connecticut Department of Social Services using claims data.
The main study aim is to evaluate the efficacy of IICAPS for youth with serious and pervasive mental health problems that places them at risk for institutional placement, and test the hypotheses that children receiving IICAPS will be less likely to exhibit out-of-control behaviors and less likely to experience a psychiatric hospitalization and/or out-of-home placement during and up to six months post-discharge from services. The second study aim is to evaluate how the efficacy of IICAPS for youth with serious and pervasive mental health problems is achieved, with specific focus on parenting practices, parental problem solving techniques, and parental perception of the child.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IICAPS | Experimental | Behavioral: Intensive In-home Child and Adolescent Psychiatric ServiceProvision of Intensive In-home Child and Adolescent Psychiatric Service, a six to seven month family-focused in-home psychiatric intervention. |
| Home-based CTC | Active comparator | Behavioral: Home-based Child Treatment CoordinationProvision of Home-based Child Treatment Coordination, a six to seven month child-focused case management service with monthly in-home visits with the child's parent/legal guardian. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- child has a Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis
- child at risk of psychiatric hospitalization due to serious out-of-control behaviors
- child resides in home of legal guardian, who is primary caregiver
- child insured by Medicaid
- score in the borderline clinical or clinical range on the Externalizing Scale of the Child Behavior Checklist (CBCL)
Key exclusion criteria (3 listed)
- referred to IICAPS by a probation officer
- suffers from an unstable, chronic medical comorbidity
- prior receipt of IICAPS
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 |
|---|---|---|
| Intensive In-home Child and Adolescent Psychiatric ServiceA six to seven month intensive intervention provided by a clinical team consisting of a master's-level clinician and a bachelor's-level mental health counselor delivering comprehensive psychiatric and case management services in the child's home. One or both members of the team works with the child and the family three times a week in the home. Delivery of direct and indirect services average 5.5 hours of service per week. | Behavioural | IICAPS |
| Home-based Child Treatment CoordinationA six to seven month home-based case management service delivered by a master's level clinician. The coordinator meets with the child's parent/legal guardian in the child's home once a month and conducts weekly phone conversations to facilitate referral and access to appropriate mental health services for the child. | Behavioural | Home-based CTC |
Primary outcome
Change in Child Out-of-control Behavior
Time frame: Baseline up to 7 months post-baseline
Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS). This instrument is administered at baseline and at the end of study treatment (IICAPS or Home-based CTC), at approximately 6 to 7 months post-baseline.
Change in Child Out-of-control Behavior
Time frame: Baseline to 12 months post-baseline
Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS). This instrument is administered at baseline and at the 12 months post-baseline.
Change in Child Out-of-control Behavior
Time frame: Up to 12 months post-baseline
Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS) monthly from baseline to 12-months post-baseline.
Change in Child Psychiatric Inpatient Admissions and Days
Time frame: Baseline (measure of prior 6 months) up to 7 months post-baseline (measuring time since baseline)
Child psychiatric inpatient admissions and days will be collected for the six-months prior to study enrollment, and measured against child psychiatric inpatient admissions and days from baseline to the end of the study treatment intervention (IICAPS or Home-based CTC), at approximately 6 to 7 months post-baseline.
Change in Child Psychiatric Inpatient Days and Admissions
Time frame: Baseline (measure of 6 months prior) to 12 months post-baseline
Child psychiatric inpatient admissions and days will be collected for the six-months prior to study enrollment, and measured against child psychiatric inpatient admissions and days from baseline to 12 months post-baseline.
Change in Child Out-of-control Behavior
Time frame: Baseline up to 7 months post-baseline
Child out-of-control behavior as measured by the Child Behavior Checklist (CBCL). This instrument is administered at baseline and at the end of study treatment (IICAPS or Home-based CTC), at approximately 6 to 7 months post-baseline.
Change in Child Out-of-control Behavior
Time frame: Baseline to 12 months post-baseline
Child out-of-control behavior as measured by the Child Behavior Checklist (CBCL). This instrument is administered at baseline and at 12 months post-baseline.
6 secondary outcomes
Change in Parenting Practices
Time frame: Baseline up to 7 months post-baseline
Change in Parenting Practices
Time frame: Baseline to 12 months post-baseline
Change in Parental Problem Solving
Time frame: Baseline up to 7 months post-baseline
Change in Parental Problem Solving
Time frame: Baseline to 12 months post-baseline
Change in Parental Perception of their Child
Time frame: Baseline up to 7 months post-baseline
Change in Parental Perception of their Child
Time frame: Baseline to 12 months post-baseline
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 14 Oct 2016.
- BackgroundWoolston JL, Adnopoz JA, Berkowitz SJ. IICAPS: A Home-Based Psychiatric Treatment for Children and Adolescents. New Haven: Yale University Press, 2007.
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 L. Woolston, M.D. principal investigator
Yale University
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 Intensive In-home Child and Adolescent Psychiatric Service and Home-based Child Treatment Coordination in people with Serious Emotional Disturbance, run by Yale 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 5 inclusion and 3 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 14 Oct 2016. 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?
Change in Child Out-of-control Behavior (time frame: Baseline up to 7 months post-baseline). The study lists 7 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 NCT01567969, 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 14 Oct 2016; AzTrials last refreshed its copy on 26 Oct 2026.