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Completed

NCT Number: NCT00339365

Promoting Infant Mental Health in Foster Care

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.

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Key information

Age range

10 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Washington

Seattle, Washington, 98195-7920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Foster care provider is not English-speaking

Treatment and study plan

Promoting First Relationships Program

Behavioral

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.

Other names: PFR

Early Education Support Program

Behavioral

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.

Other names: EES

Primary outcomes

  1. Toddler Attachment Sort-45

    Time frame: Measured at Months 1, 6, and 12 post-treatment

  2. Nursing Child Assessment Satellite Training (NCAST) Teaching Scale

    Time frame: Measured at Months 1, 6, and 12 post-treatment

  3. Indicator of Parent-Child Interaction (IPCI)

    Time frame: Measured at Months 1, 6, and 12 post-treatment

  4. Brief Infant-Toddler Social Emotional Assessment

    Time frame: Measured at Months 1, 6, and 12 post-treatment

  5. Bayley Scales of Infant Development, 3rd Edition Screening Test

    Time frame: Measured at baseline and Month 6 post-treatment

Secondary outcomes

  1. Parenting Stress Index/Short Form

    Time frame: Measured at Months 1, 6, and 12 post-treatment

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: Measured at Months 1, 6, and 12 post-treatment

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jun 21, 2006
Registry last updated
May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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