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Supporting Parents Program: Intervention for Families in CPS (SPP)

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ClinicalTrials.gov Identifier: NCT01332851
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Monica Oxford, University of Washington

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.

Condition or disease Intervention/treatment Phase
Child Abuse Child Neglect Behavioral: Promoting First Relationships (PFR) Behavioral: Resource and Referral Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Training Social Work Providers: Intervention for Maltreating Families of Infants
Study Start Date : January 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Active Comparator: Resource & Referral
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
Needs assessment, followed with a resource packet sent by mail




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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 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.

  4. 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 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.

  5. Child Emotion Regulation [ Time Frame: Baseline and at the 3 month follow up (~ 7 months post baseline) ]
    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.

  6. Child Engagement/Exploration [ Time Frame: Baseline and at the 3 month follow up (~ 7 months post baseline) ]
    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.

  7. 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) ]
    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.

  8. 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) ]

    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.


  9. 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) ]
    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.

  10. 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) ]
    "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.

  11. Maternal Unrealistic Expectations [ Time Frame: Baseline and Post intervention (~ 4 months post baseline) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332851


Locations
United States, Washington
University of Washington, Family & Child Nursing
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Monica L Oxford, PhD University of Washington

Additional Information:
Publications of Results:
Responsible Party: Monica Oxford, Research Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01332851     History of Changes
Other Study ID Numbers: D-103010-S
1R01HD061362-01A2 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2011    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: June 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Monica Oxford, University of Washington:
child welfare
child protective services
child abuse
child neglect
infant
parenting