Child DevelopmentPhase 2/3NCT00339365
Promoting Infant Mental Health in Foster Care
A Phase 2/3 study testing Promoting First Relationships Program and Early Education Support Program in people with Child Development and Child Behavior Disorders, run by University of Washington at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of the Promoting First Relationships (PFR) program versus an Early Education Support (EES) program in promoting infant well-being, preventing emotional and behavioral problems, countering developmental delay, and reducing placement instability in young foster care children. Read more about this study
- Who is it for?
- Ages 10 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Child Behavior Disorders, Reactive Attachment Disorder
- What is being tested?
- Promoting First Relationships Program and Early Education Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 2011
- Phase
- Phase 2/3
- 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 10 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Transitioned into foster care, currently within foster care, or from foster care in past three months prior to study entry in Pierce County, WA
- Primary caregiver is foster care provider, kin caregiver, or biological parent
Who cannot join
- Foster care provider is not English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington
Seattle, Washington, 98195-7920
About this study
This study will evaluate the effectiveness of the Promoting First Relationships (PFR) program versus an Early Education Support (EES) program in promoting infant well-being, preventing emotional and behavioral problems, countering developmental delay, and reducing placement instability in young foster care children.
Read the detailed description
Infants who enter foster care are at risk for developing multiple social and emotional problems later in life. These behavioral issues often result in foster children being placed with multiple different families during their childhoods. In turn, an unstable family life can lead to serious conduct disorders and mental health problems. The infants' loss of their first attachment relationship heightens the risks for developing these problems, even if the quality of care was poor prior to removal. Infants' reactions to this loss, combined with other vulnerabilities, complicate the development of new secure attachments to their foster care families. Garnering a secure attachment relationship between foster parents and foster infants may reduce the infant's risk for developing problematic mental health and conduct issues. PFR is a family therapy intervention focused on aiding foster care parents to cultivate secure attachments with their foster infants. This study will evaluate the effectiveness of the PFR program versus an EES program in promoting attachment security and infant well-being, preventing emotional and behavioral problems, countering developmental delay, and reducing placement instability in young foster care children.
Participants in this single-blind study will be randomly assigned to receive either PFR or EES. Both interventions will be administered by a trained staff member of a community agency. Participants assigned to PFR will receive ten weekly home visits that will focus on promoting the development of a secure attachment between foster parents and infants. EES will consist of three monthly home visits, during which infants will be assessed and referred for additional care if necessary. EES participants will not receive any training. Outcomes will be assessed at 1, 6, and 12 months post-intervention for all participants.
- Being tested
- Promoting First Relationships Program, Early Education Support Program
- Keywords
- Infants, Toddlers, Attachment, Maltreatment, Foster Care
- Medical subject headings
- Child Behavior Disorders, Reactive Attachment Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting First Relationships ProgramBehavioural
Also called PFR
Participants assigned to PFR will receive ten weekly home visits that will focus on promoting the development of a secure attachment between foster parents and infants.
Early Education Support ProgramBehavioural
Also called EES
EES will consist of three monthly home visits, during which infants will be assessed and referred for additional care if necessary. EES participants will not receive any training.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Promoting first relationships group Receives: Behavioral: Promoting First Relationships Program |
| 2 | Active comparator | Early education support group Receives: Behavioral: Early Education Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toddler Attachment Sort-45
Measured: Measured at Months 1, 6, and 12 post-treatment
Nursing Child Assessment Satellite Training (NCAST) Teaching Scale
Measured: Measured at Months 1, 6, and 12 post-treatment
Indicator of Parent-Child Interaction (IPCI)
Measured: Measured at Months 1, 6, and 12 post-treatment
Brief Infant-Toddler Social Emotional Assessment
Measured: Measured at Months 1, 6, and 12 post-treatment
Bayley Scales of Infant Development, 3rd Edition Screening Test
Measured: Measured at baseline and Month 6 post-treatment
Secondary outcomes (2)
Parenting Stress Index/Short Form
Measured: Measured at Months 1, 6, and 12 post-treatment
Patient Health Questionnaire (PHQ-9)
Measured: Measured at Months 1, 6, and 12 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startApr 2007
- Primary completionJan 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Susan J. Spieker, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339365
- Sponsor's protocol ID
- R01MH077329
- Other IDs
- R01MH077329, DSIR 84-CTS
- Status last verified
- May 2012
- First submitted
- 19 Jun 2006
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Infant Mental Health in Foster Care
- ClinicalTrials.gov ID
- NCT00339365
- Acronym / sponsor ID
- R01MH077329
- Keywords
- Infants, Toddlers, Attachment, Maltreatment, Foster Care
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Jun 2006 (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 evaluate the effectiveness of the Promoting First Relationships (PFR) program versus an Early Education Support (EES) program in promoting infant well-being, preventing emotional and behavioral problems, countering developmental delay, and reducing placement instability in young foster care children.
Detailed description
Infants who enter foster care are at risk for developing multiple social and emotional problems later in life. These behavioral issues often result in foster children being placed with multiple different families during their childhoods. In turn, an unstable family life can lead to serious conduct disorders and mental health problems. The infants' loss of their first attachment relationship heightens the risks for developing these problems, even if the quality of care was poor prior to removal. Infants' reactions to this loss, combined with other vulnerabilities, complicate the development of new secure attachments to their foster care families. Garnering a secure attachment relationship between foster parents and foster infants may reduce the infant's risk for developing problematic mental health and conduct issues. PFR is a family therapy intervention focused on aiding foster care parents to cultivate secure attachments with their foster infants. This study will evaluate the effectiveness of the PFR program versus an EES program in promoting attachment security and infant well-being, preventing emotional and behavioral problems, countering developmental delay, and reducing placement instability in young foster care children.
Participants in this single-blind study will be randomly assigned to receive either PFR or EES. Both interventions will be administered by a trained staff member of a community agency. Participants assigned to PFR will receive ten weekly home visits that will focus on promoting the development of a secure attachment between foster parents and infants. EES will consist of three monthly home visits, during which infants will be assessed and referred for additional care if necessary. EES participants will not receive any training. Outcomes will be assessed at 1, 6, and 12 months post-intervention for all participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Promoting First Relationships ProgramPromoting first relationships group |
| 2 | Active comparator | Behavioral: Early Education Support ProgramEarly education support group |
Who may qualify
- Ages
- 10 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Transitioned into foster care, currently within foster care, or from foster care in past three months prior to study entry in Pierce County, WA
- Primary caregiver is foster care provider, kin caregiver, or biological parent
Key exclusion criteria (1 listed)
- Foster care provider is not English-speaking
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 |
|---|---|---|
| Promoting First Relationships ProgramAlso: PFRParticipants assigned to PFR will receive ten weekly home visits that will focus on promoting the development of a secure attachment between foster parents and infants. | Behavioural | 1 |
| Early Education Support ProgramAlso: EESEES will consist of three monthly home visits, during which infants will be assessed and referred for additional care if necessary. EES participants will not receive any training. | Behavioural | 2 |
Primary outcome
Toddler Attachment Sort-45
Time frame: Measured at Months 1, 6, and 12 post-treatment
Nursing Child Assessment Satellite Training (NCAST) Teaching Scale
Time frame: Measured at Months 1, 6, and 12 post-treatment
Indicator of Parent-Child Interaction (IPCI)
Time frame: Measured at Months 1, 6, and 12 post-treatment
Brief Infant-Toddler Social Emotional Assessment
Time frame: Measured at Months 1, 6, and 12 post-treatment
Bayley Scales of Infant Development, 3rd Edition Screening Test
Time frame: Measured at baseline and Month 6 post-treatment
2 secondary outcomes
Parenting Stress Index/Short Form
Time frame: Measured at Months 1, 6, and 12 post-treatment
Patient Health Questionnaire (PHQ-9)
Time frame: Measured at Months 1, 6, and 12 post-treatment
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 17 May 2012.
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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.
Susan J. Spieker, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Promoting First Relationships Program and Early Education Support Program in people with Child Development and Child Behavior Disorders, run by University of Washington 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 2 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 17 May 2012. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Toddler Attachment Sort-45 (time frame: Measured at Months 1, 6, and 12 post-treatment). The study lists 5 primary outcomes in all. 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 17 May 2012.