Supporting Parents Program: Intervention for Families in CPS (SPP)
2018年5月4日 更新者：Monica Oxford、University of Washington
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
270
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Washington
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Seattle、Washington、美国、98105
- University of Washington, Family & Child Nursing
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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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.
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有源比较器：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.
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Needs assessment, followed with a resource packet sent by mail
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Child Welfare Outcomes: CWS Removal From Birth Parent Home
大体时间：1 year post intervention
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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.
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1 year post intervention
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Parental Sensitivity (Video Recorded Observation Coded by Blind Coders)
大体时间：Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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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.
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Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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Secure Base Behavior (Observation During Research Visit; Higher Score Indicates Greater Security)
大体时间：Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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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.
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Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Parenting Stress: Dysfunctional Interaction
大体时间：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)
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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.
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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)
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Parent Stress: Competence (Higher Score Means More Stress)
大体时间：Baseline 3-month post-intervention (~7 months post baseline), 6-month follow up (~ ten months post baseline)
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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.
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Baseline 3-month post-intervention (~7 months post baseline), 6-month follow up (~ ten months post baseline)
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Child Social Emotional Development (Higher Scores Indicate More Competence)
大体时间：Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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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.
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Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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Child Behavior Problems
大体时间：Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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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.
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Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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Child Emotion Regulation
大体时间：Baseline and at the 3 month follow up (~ 7 months post baseline)
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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.
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Baseline and at the 3 month follow up (~ 7 months post baseline)
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Child Engagement/Exploration
大体时间：Baseline and at the 3 month follow up (~ 7 months post baseline)
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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.
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Baseline and at the 3 month follow up (~ 7 months post baseline)
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Child Atypical Affective Communication (Observation)
大体时间：Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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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.
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Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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Parent-Child Interaction (Video Recorded Observation Coded by Blind Coders)
大体时间：Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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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. |
Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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Parental Confidence
大体时间：Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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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.
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Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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Parental Mindfulness
大体时间：Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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"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.
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Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)
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Maternal Unrealistic Expectations
大体时间：Baseline and Post intervention (~ 4 months post baseline)
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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.
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Baseline and Post intervention (~ 4 months post baseline)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Monica L Oxford, PhD、University of Washington
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年10月1日
研究注册日期
首次提交
2011年4月7日
首先提交符合 QC 标准的
2011年4月8日
首次发布 (估计)
2011年4月11日
研究记录更新
最后更新发布 (实际的)
2018年6月7日
上次提交的符合 QC 标准的更新
2018年5月4日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.