Child AbuseSPPNCT01332851
Supporting Parents Program: Intervention for Families in CPS
A study testing Promoting First Relationships (PFR) and Resource and Referral in people with Child Abuse and Child Neglect, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Abuse, Child Neglect
- What is being tested?
- Promoting First Relationships (PFR) and Resource and Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Family & Child Nursing
Seattle, Washington, 98105
About this study
Official title: Training Social Work Providers: Intervention for Maltreating Families of Infants
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.
Read the detailed description
Child maltreatment has well-established, wide-ranging, and long-term negative effects on children. Most children who have experienced maltreatment and are receiving services through the Child Welfare System (CWS) remain in their homes with their caregivers. While the need for parenting services is extensive, few intervention programs have proven to be efficacious in reducing child abuse and neglect within the CWS population, especially for infants and toddlers. It is essential that social service practitioners within the CWS delivery system are equipped to provide brief interventions to maltreating parents. This grant, "Training Social Work Providers: Intervention for Maltreating Families of Infants and Toddlers," is an evaluation of a training program for social welfare providers to implement a brief attachment theory-based intervention to families who have been investigated for child abuse and neglect by Child Protective Services. The program (Promoting First Relationships [PFR]; Kelly, Buehlman, \& Caldwell, 2000) will be tested at two levels: through social welfare practice and at the level of outcomes for children and families.
Social service providers will be trained to deliver PFR to families under investigation for maltreatment by the Department of Social and Health Services, in two counties in Washington State. Subsequently, families under investigation by CPS will be recruited into the study and randomly assigned to the experimental group (receiving the PFR intervention) or to the comparison group (receiving resources and referrals).
The specific aims of this study are to (1) Test the effectiveness of training community social welfare service providers in the use of attachment-based interventions by measuring their pre-training and post-training service provision strategies and interactions with maltreating families; (2) To test the effects of a relationship and attachment-based intervention with infants/toddlers of parents identified as maltreating by comparing them to a control group on rates of re-referral to CPS, severity of referral, and foster care placement; and (3) To conduct a test of the effectiveness of an attachment-based intervention on child well-being by comparing experimental and comparison groups on important outcomes (attachment security, emotional regulation, behavior, and developmental functioning).
RELEVANCE Child maltreatment is a serious public health issue, affecting close to a million children nationally every year. The establishment of effective evidence-based interventions for high-risk families is essential to curtail the devastating long-term effects of maltreatment. The proposed study tests the feasibility and effectiveness of a well-documented relationship-based intervention (Promoting First Relationships) in improving outcomes for families referred to CPS for maltreatment.
- Conditions
- Child Abuse, Child Neglect
- Being tested
- Promoting First Relationships (PFR), Resource and Referral
- Keywords
- child welfare, child protective services, child abuse, child neglect, infant, parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting First Relationships (PFR)Behavioural
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.
Resource and ReferralBehavioural
Needs assessment, followed with a resource packet sent by mail
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Resource and Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Parenting stress was measured by scales selected from the Parenting Stress Index and the Parenting Stress Index-Short Form (PSI-3, PSI-SF; Abidin, 1995). The Parent-Child Dysfunctional Interaction Scale from the PSI-SF (11 items). Items were rated on 4-point scales (strongly agree to strongly disagree). Two items measuring parental educational attainment from the original parenting competence scale were omitted due to excessive missing data. Higher scores indicate greater parental stress associated with feelings of dysfunctional parent-child interactions (i.e., interactions are not reinforcing or satisfying). Alphas ranged from .71-.94 across time points. Possible range 11-55, observed range 12 to 43.
Measured: 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)
At baseline, 3-month post-intervention follow-up, and 6-month post-intervention follow-up, parenting stress was measured by scales selected from the Parenting Stress Index and the Parenting Stress Index-Short Form (PSI-3, PSI-SF; Abidin, 1995). The Parenting Competence Scale from the PSI-3 (11 items) was used. Items were rated on 4-point scales (strongly agree to strongly disagree). Two items measuring parental educational attainment from the original parenting competence scale were omitted due to excessive missing data. Higher scores indicate greater parental stress associated with feelings of incompetence. Alphas ranged from .71-.94 across time points. Possible range 11 - 55, observed range 11 - 39.
Measured: 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)
Child social-emotional competence (11 items; alphas = .69-.70) was measured by the Brief Infant Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan \& Carter, 2002). Possible range is 0 - 22. Parent report of child social-emotional competence in the last month were rated on a 3-point scale (not true/rarely; somewhat true/sometimes; very true/often). Higher scores indicate more competence.
Measured: 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
Child behavior problems (31 items; alphas =.77-.79) were measured by parent report on the Brief Infant Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan \& Carter, 2002). Descriptions of positive and problematic social-emotional behaviors in the last month were rated on a 3-point scale (not true/rarely; somewhat true/sometimes; very true/often; items score 0, 1, 2 respectively). Higher score indicates more child behavior problems as noted by the parent. Possible range is 0 - 62.
Measured: 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
Bayley Behavior Ratings (Bayley, 1993) to assess emotion regulation. At baseline and again at the 3-month follow-up, blinded research visitors rated the child's behavior during administration of a standardized developmental test using the Bayley Behavior Rating Scales (BRS; Bayley 1993). Seven items in the BRS comprise the emotion regulation scale and capture how well the child adapts to challenging stimuli and frustration (alphas = .79-.83). Possible range is 1 - 5, the mean of seven items scored from 1 to 5. Higher scores indicate better emotional regulation.
Measured: Baseline and at the 3 month follow up (~ 7 months post baseline)
Child Engagement/Exploration
At baseline and again at the 3-month follow-up, blinded research visitors rated the child's behavior during administration of a standardized developmental test using the Bayley Behavior Rating Scales (BRS; Bayley 1993). Engagement/exploration consists of six items rated for exploratory behavior in the testing situation (alphas = .75-.76). The items were scored on a rage of 1 to 5, the mean of the six items was computed and the possible range is 1 to 5. Higher scores indicate more engagement.
Measured: Baseline and at the 3 month follow up (~ 7 months post baseline)
Child Atypical Affective Communication (Observation)
Atypical, affective communication were 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 additional items tapping atypical, affective communication. Immediately after research home visits, the 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 scaled with weights for the D hotspot. Because scores are based on standardized item scores, the possible range is large, difficult to determine, and not reported in the instrument manual. Observed range -1.511 to + .860.
Measured: Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
Parent-Child Interaction (Video Recorded Observation Coded by Blind Coders)
Coding Interactive Behavior-Child \& Parent Outcomes (CIB; Feldman, 1998). Parent-child 10-minute free play interaction coded for child social engagement, child negative affect, and dyadic reciprocity; parental sensitivity and reciprocity, parental intrusiveness, and parental withdrawal.
NOTE: THIS MEASURE WAS COLLECTED AND CODED. HOWEVER, THE MEASURE SUFFERED FROM LOW INTERNAL CONSISTENCY AND RESTRICTED VARIATION (I.E., A LARGE PORTION OF SCORES WERE NEAR THE MAXIMUM POSSIBLE VALUE). WE DID COMPARE SCORES BY CONDITION AND ALL COMPARISONS INDICATED NONSIGNIFICANT DIFFERENCES BETWEEN PFR AND R\&R CONDITIONS. DUE TO LOW RELIABILITY AND RESTRICTED VARIATION OF THE MEASURE, IT WAS DECIDED TO NOT REPORT THESE RESULTS.
Measured: Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
Parental Confidence
Caregiving Helplessness Questionnaire (CHQ; George, Coulson, Majany, \& Soloman, 1995) subscales: parent-child frightened and parent helplessness. NOTE: THIS MEASURE WAS COLLECTED AND COMPARISONS BETWEEN PFR AND R\&R INDICATED NONSIGNIFICANT DIFFERENCES. DUE TO LOW INTERNAL CONSISTENCY OF THE MEASURE, IT WAS DECIDED TO NOT REPORT PFR VS. R\&R COMPARISONS FOR THIS MEASURE.
Measured: Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
Parental Mindfulness
"About My Baby": three open-ended questions; coded to assess "mindfulness" representations of the child's mental life. NOTE: THIS MEASURE WAS DROPPED FROM THE STUDY. OPEN-ENDED QUESTIONS WERE INCLUDED IN INITIAL ASSESSMENTS. ANSWERS WERE REVIEWED BY THE RESEARCH TEAM, AND IT WAS DECIDED THAT RELIABLE AND VALID CODING WAS NOT POSSIBLE.
Measured: Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
Maternal Unrealistic Expectations
Parent Opinion Questionnaire (POQ; Azar et al., 1984): questionnaire to assess unrealistic parental expectations of child behavior in the areas of self-care, help and affection to parents, leaving children alone, proper feelings and behavior punishment, and family responsibility. NOTE: THIS MEASURE WAS COLLECTED. RESPONDENTS WERE OFFENDED BY SOME QUESTIONS, WE REDUCED THE NUMBER OF QUESTIONS AT BASELINE AND COLLECTED THE FULL INSTRUMENT AT FOLLOW UP 1. HOWEVER, IT SHOWED LIMITED VARIABILITY. COMPARISONS BETWEEN PFR AND R\&R CONDITIONS INDICATED NONSIGNIFICANT DIFFERENCES. DUE TO THE LIMITED VARIABILITY, IT WAS DECIDED NOT TO REPORT THESE RESULTS.
Measured: Baseline and Post intervention (~ 4 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 posted11 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Monica Oxford, University of Washington
- Investigators
- Monica L Oxford, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332851
- Sponsor's protocol ID
- D-103010-S
- Other IDs
- 1R01HD061362-01A2
- Acronym
- SPP
- Status last verified
- May 2018
- First submitted
- 7 Apr 2011
- Last updated
- 7 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27646148Jones 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.
PubMed 37146219
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Social Work Providers: Intervention for Maltreating Families of Infants
- ClinicalTrials.gov ID
- NCT01332851
- Acronym / sponsor ID
- SPP / D-103010-S
- Conditions
- Child Abuse, Child Neglect
- Keywords
- child welfare, child protective services, child abuse, child neglect, infant, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Posted 7 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Child maltreatment has well-established, wide-ranging, and long-term negative effects on children. Most children who have experienced maltreatment and are receiving services through the Child Welfare System (CWS) remain in their homes with their caregivers. While the need for parenting services is extensive, few intervention programs have proven to be efficacious in reducing child abuse and neglect within the CWS population, especially for infants and toddlers. It is essential that social service practitioners within the CWS delivery system are equipped to provide brief interventions to maltreating parents. This grant, "Training Social Work Providers: Intervention for Maltreating Families of Infants and Toddlers," is an evaluation of a training program for social welfare providers to implement a brief attachment theory-based intervention to families who have been investigated for child abuse and neglect by Child Protective Services. The program (Promoting First Relationships [PFR]; Kelly, Buehlman, \& Caldwell, 2000) will be tested at two levels: through social welfare practice and at the level of outcomes for children and families.
Social service providers will be trained to deliver PFR to families under investigation for maltreatment by the Department of Social and Health Services, in two counties in Washington State. Subsequently, families under investigation by CPS will be recruited into the study and randomly assigned to the experimental group (receiving the PFR intervention) or to the comparison group (receiving resources and referrals).
The specific aims of this study are to (1) Test the effectiveness of training community social welfare service providers in the use of attachment-based interventions by measuring their pre-training and post-training service provision strategies and interactions with maltreating families; (2) To test the effects of a relationship and attachment-based intervention with infants/toddlers of parents identified as maltreating by comparing them to a control group on rates of re-referral to CPS, severity of referral, and foster care placement; and (3) To conduct a test of the effectiveness of an attachment-based intervention on child well-being by comparing experimental and comparison groups on important outcomes (attachment security, emotional regulation, behavior, and developmental functioning).
RELEVANCE Child maltreatment is a serious public health issue, affecting close to a million children nationally every year. The establishment of effective evidence-based interventions for high-risk families is essential to curtail the devastating long-term effects of maltreatment. The proposed study tests the feasibility and effectiveness of a well-documented relationship-based intervention (Promoting First Relationships) in improving outcomes for families referred to CPS for maltreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promoting First Relationships (PFR) | Experimental | Behavioral: Promoting First Relationships (PFR)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. |
| Resource & Referral | Active comparator | Behavioral: Resource and ReferralThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 (PFR)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. | Behavioural | Promoting First Relationships (PFR) |
| Resource and ReferralNeeds assessment, followed with a resource packet sent by mail | Behavioural | Resource & Referral |
Primary outcome
Child Welfare Outcomes: CWS Removal From Birth Parent Home
Time frame: 1 year post intervention
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.
Parental Sensitivity (Video Recorded Observation Coded by Blind Coders)
Time frame: Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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.
Secure Base Behavior (Observation During Research Visit; Higher Score Indicates Greater Security)
Time frame: 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 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.
11 secondary outcomes
Parenting Stress: Dysfunctional Interaction
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline and at the 3 month follow up (~ 7 months post baseline)
Child Engagement/Exploration
Time frame: Baseline and at the 3 month follow up (~ 7 months post baseline)
Child Atypical Affective Communication (Observation)
Time frame: Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
Parent-Child Interaction (Video Recorded Observation Coded by Blind Coders)
Time frame: Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
Parental Confidence
Time frame: Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
Parental Mindfulness
Time frame: Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
Maternal Unrealistic Expectations
Time frame: Baseline and Post intervention (~ 4 months post baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27646148Oxford 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.
- Derived from this study: PubMed 37146219Jones 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.
- Promoting First Relationships (PFR)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Monica L Oxford, 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 study testing Promoting First Relationships (PFR) and Resource and Referral in people with Child Abuse and Child Neglect, 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 6 inclusion and 4 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 7 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 7 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Child Welfare Outcomes: CWS Removal From Birth Parent Home (time frame: 1 year post intervention). The study lists 3 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 NCT01332851, which also lists 2 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 7 Jun 2018.