NCT01332851

Brief Summary

The study evaluates the feasibility and effectiveness of a well-documented relationship-based intervention (Promoting First Relationships), compared to a resource and referral condition, in improving outcomes for families of infants and toddlers referred to Child Protective Services (CPS) for maltreatment. In addition, it evaluates the effectiveness of training community social service workers in providing the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 7, 2018

Completed
Last Updated

June 7, 2018

Status Verified

May 1, 2018

Enrollment Period

4.4 years

First QC Date

April 7, 2011

Results QC Date

August 9, 2017

Last Update Submit

May 4, 2018

Conditions

Keywords

child welfarechild protective serviceschild abusechild neglectinfantparenting

Outcome Measures

Primary Outcomes (3)

  • Child Welfare Outcomes: CWS Removal From Birth Parent Home

    Official child welfare administrative records indicating whether child was removed from the birth parent home within one year of parent completing intervention (or one year after estimated date intervention would have been completed, for parents who did not complete). Data were analyzed with a survival model that predicted hazard of being removed from the birth parent home.

    1 year post intervention

  • Parental Sensitivity (Video Recorded Observation Coded by Blind Coders)

    Parent sensitivity was measured at all four time points by a modified total score of the Nursing Child Assessment Teaching Scale (NCATS; Barnard, 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction were scored. The scale was modified to exclude some items from the original measure that demonstrated low variability in other studies. A total score was based on 45 items, possible range 0 - 45. Items covered mutuality (e.g. contingency, gaze, and positive affect), caregiver verbal and nonverbal support of child, and sensitive instruction during the teaching task. Items were scored yes (1) or no (0), and yes scores were summed. Cronbach's alpha for the sensitivity scale ranged from .68 to .72. A single, blinded coder was trained to reliability by a certified NCATS instructor and passed regular reliability checks. Higher scores indicate greater parental sensitivity.

    Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)

  • Secure Base Behavior (Observation During Research Visit; Higher Score Indicates Greater Security)

    Secure base behavior was measured with the Toddler Attachment Sort-45 (TAS-45; Kirkland, Bimler, Drawneek, McKim, \& Schölmerich, 2004). The TAS-45 is based on 39 items from the Attachment Q-Sort (AQS; Waters, 1987), an attachment measure that has been extensively validated (van IJzendoorn, Vereijken, Bakermans-Kranenburg, \& Riksen-Walraven, 2004), plus six items tapping atypical affective communication. After home visits, research visitors sorted cards for 45 descriptive statements of child attachment behavior into five piles representing "most like" to "least like" the child. Item scores were standardized within individuals and then compared to a security profile to arrive at an security score. Higher value indicates greater secure base behavior. Because scores are based standardized item scores weighted by proximity to the secure profile, the possible range is large, difficult to determine, and not reported in the instrument manual. The observed range was from -.62 to +1.00.

    Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)

Secondary Outcomes (11)

  • Parenting Stress: Dysfunctional Interaction

    Baseline, post intervention (approximately 4 months from baseline, 3 month follow up from post intervention (~7 months from baseline), 6 month follow up (~ 10 months from baseline)

  • Parent Stress: Competence (Higher Score Means More Stress)

    Baseline 3-month post-intervention (~7 months post baseline), 6-month follow up (~ ten months post baseline)

  • Child Social Emotional Development (Higher Scores Indicate More Competence)

    Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)

  • Child Behavior Problems

    Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)

  • Child Emotion Regulation

    Baseline and at the 3 month follow up (~ 7 months post baseline)

  • +6 more secondary outcomes

Study Arms (2)

Promoting First Relationships (PFR)

EXPERIMENTAL

PFR is a strengths-based 10 week in-home parenting intervention based on attachment theory. Each week has a theme for discussion, an activity, and time for "joining" - checking in with the parent, listening to their concerns and establishing a positive, supportive relationship. The sessions include handouts which focus on the content area covered that day and applying a topic to their relationship with their child. The provider also videotapes playtime between parent and child. On alternate weeks, the provider watches the video with the parent, reflecting on both the parent's and the child's needs. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent identify her own feelings and needs around parenting.

Behavioral: Promoting First Relationships (PFR)

Resource & Referral

ACTIVE COMPARATOR

This condition consists of 1) Resource and Referral assistance provided over the phone, and 2) Local Services Resource Packet. The participant receives a phone call from a Resource and Referral Specialist to conduct a needs assessment to identify the particular needs or concerns of the family (such as housing needs, mental health, tangible goods). If a need is identified, the Referral and Referral Specialist will provide the family with local information regarding the stated need. The R\&R provider makes two follow-up check in calls with the families. In addition, families can call the Research and Referral Specialist if additional needs arise. The resource packet includes information organized by type of need or resource. These packets are updated regularly as services change over time.

Behavioral: Resource and Referral

Interventions

PFR is a parenting intervention based on attachment theory and is strengths based. It is a 10 week intervention that is delivered in the home of the family.

Promoting First Relationships (PFR)

Needs assessment, followed with a resource packet sent by mail

Resource & Referral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biological parents and their child aged 10-24 months, who is an identified victim for referral to CPS, and who are parenting their child a majority of the time
  • Families served by CPS offices in Snohomish and Skagit counties, in the state of Washington
  • Families at moderate to high risk for maltreatment (physical abuse, neglect, or emotional maltreatment) and under investigation by Child Protective Services
  • English speaking primary caregiver
  • Telephone access
  • Current housing

You may not qualify if:

  • Experiencing an acute crisis (homelessness, hospitalization, imprisonment)
  • Identified child (in a risk only CPS intake) or identified victim (in CPS intakes with allegations) has a voluntary services agreement within 2 weeks of a newly opened investigation
  • Identified child (in a risk only CPS intake) or identified victim (in CPS intakes with allegations) has a dependency filing within 2 weeks of a newly opened investigation
  • Previously received the Promoting First Relationships intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington, Family & Child Nursing

Seattle, Washington, 98105, United States

Location

Related Publications (2)

  • Oxford ML, Spieker SJ, Lohr MJ, Fleming CB. Promoting First Relationships(R): Randomized Trial of a 10-Week Home Visiting Program With Families Referred to Child Protective Services. Child Maltreat. 2016 Nov;21(4):267-277. doi: 10.1177/1077559516668274. Epub 2016 Sep 21.

  • Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.

Related Links

MeSH Terms

Interventions

Health ResourcesReferral and Consultation

Intervention Hierarchy (Ancestors)

Health PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and EvaluationProfessional PracticeOrganization and AdministrationHealth Services Administration

Limitations and Caveats

Generalizability limited by sample selection criteria. Follow-up was only 6-months post-intervention for most outcomes although child welfare records covered 1 year post-intervention. Parent report was used for some key outcomes.

Results Point of Contact

Title
Dr. Monica Oxford
Organization
Family and Child Nursing, University of Washington

Study Officials

  • Monica L Oxford, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 11, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

June 7, 2018

Results First Posted

June 7, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations