MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Pre and Post-natal Maternal Substance Use
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Change in Infant Traumatic Stress Questionnaire (ITSQ)
研究概览
简要总结
The goal of the project is to improve child well-being, permanency, and safety, and reduce the risk for involvement in the child welfare system for families with children pre-birth to five years who are affected by parental substance use disorders (SUD). The project will integrate with SUD treatment programs for pregnant/parenting women and their children and provide an evidence-based therapeutic model, Mothering from the Inside Out (MIO) and Child Parent Psychotherapy (CPP). MIO-CPP promotes the development of parental reflective functioning and strengthen parent/child attachment. The project will also examine the role of Certified Recovery Specialists (CRS) to provide case management services to parents during their enrollment in therapy.
MIO is an individual, manualized, psychotherapeutic intervention designed to promote parental reflective functioning in mothers who are in treatment for SUDs and/or other mental health problems, and caring for a child in-utero through five years old. CPP is typically offered through weekly sessions with the mother-child dyad that last 1 to 1.5 hours.
The MIO-CPP (intervention) model will begin with 6 sessions of MIO for each study participant, with the CPP assessment and engagement phase embedded during this time. This phase will be followed by the dyadic mother-child phase, the core intervention stage of CPP. If a parent needs additional stabilization, more individual time can be added. During the core phase of dyadic CPP the Child Parent Specialists will continue to build and strengthen parents' reflective functioning by embedding aspects from MIO.
Beginning in Phase 2, participant dyads will be assigned a Certified Recovery Specialists (CRSs) who will provide services to support them as they transition out of SUD treatment and back into their home communities. We will recruit and hire 2 PA CRSs to join the therapeutic team. CRS services will include but not be limited to: assisting clients with securing housing and employment and connecting to outpatient and other recovery support services (e.g. 12-step programs), and child, medical and behavioral health care as needed. The plan for the timing to introduce CRS services and their issues of focus will be defined through quality improvement methodology during Phase 1.
We will use a quasi-experimental trial design with historical controls as well as qualitative interviews to assess effectiveness and efficiency of MIO-CPP when paired with CRS, on parent and child outcomes including therapy engagement, parent/caregiver well-being, child well-being, and family well-being. The study will take place over two phases. Eligible caregivers in Phase 1 will receive MIO-CPP (control), while participants enrolled in Phase 2 will receive a MIO-CPP while also being paired with a CRS.
The recruitment for study participants will stop when 320 mother-child dyads have enrolled in the study. Participants will include mother-child dyads from families involved with residential SUD treatment programs serving women and children in Philadelphia and Bucks counties. In Bucks County we will receive referrals from Libertae Inc. in Bensalem, Pennsylvania (PA). In Philadelphia, we will receive referrals from Gaudenzia Hutchinson Place and the Gaudenzia Winner Program.
Data collection from participants will occur at four time points during the study: 1) when participants are enrolled; 2) 3 months following enrollment; 3) 6 months following enrollment; and 4) 9 months following enrollment or when the participant ends their participation in weekly therapy sessions if sooner than 9 months following enrollment. Study measures will include: 1) Parent/Caregiver Well-being: a) maternal reflective functioning, b) depression, anxiety, and trauma-related symptoms, c) parental substance use and move toward recovery; d) parenting stress; e) parent-child relationship; 2) Child Well-being: a) behavior problems, b) executive functions; c) socialization skills; 3) Family Well-being: a) child welfare involvement, b) reunifications.
As part of this study, investigator will acquire administrative data about the safety and permanency of children and adult recovery for all study participants. The Primary Investigator will request substance use treatment data from the City of Philadelphia Department of Human Services. The requested data elements will include whether the study child has a child welfare record, the types of allegations of abuse or neglect, and when the allegations occurred (from birth to present day). Additionally, investigators will request all available substance use treatment records will be requested for adults who are a part of a study case for the year prior to enrollment in the study to one year following their enrollment in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women actively receiving treatment for Substance Use Disorder at one of three participating residential substance use disorder clinics in Philadelphia and Bucks Counties (Libertae Inc.; Gaudenzia's Hutchinson House; Gaudenzia Winner Program).
- •Must be at least six months pregnant or must have a child 5 years old or younger.
- •Must have access to child - children must either reside with mother, or, if the child is in foster/kinship care, the goal must be reunification.
排除标准
- •Duration of affiliation with treatment center:
- •Women will not be referred for enrollment before they have been affiliated with the treatment facility for at least 14 days and will not be referred if they are less than 45 days from discharge.
- •These limitations will ensure that women are not referred to our study too quickly as they are adjusting to residential treatment, but will also ensure that we do not enroll women too soon before they are discharged from residential treatment.
- •Non-English Speaking The study will not enroll mothers who would be unable to receive the intervention services in English without the assistance of an interpreter. Due to the duration of the study intervention as well as the frequency of visits between the Child-Parent Specialist and the client, it would not be feasible to ensure that an interpreter would also be available for all visits.
研究组 & 干预措施
MIO-CPP
The 9 month MIO-CPP model will begin with the standard 12 weeks of MIO for each mother, with the CPP assessment and engagement phase embedded during this time. This phase will be followed by the dyadic mother-child phase, the core intervention stage of CPP. If a parent needs additional stabilization, more individual time can be added. During the core phase of dyadic CPP the Child Parent Specialists will continue to build and strengthen parents' reflective functioning by embedding aspects from MIO. The 9 month MIO-CPP model will begin with the standard 12 weeks of MIO for each mother, with the CPP assessment and engagement phase embedded during this time. This phase will be followed by the dyadic mother-child phase, the core intervention stage of CPP. If a parent needs additional stabilization, more individual time can be added.
干预措施: MIO-CPP (Behavioral)
MIO-CPP-CRS
In Phase 2, participants will receive MIO-CPP therapy, as well as support from a CRS. The MIO-CPP model will begin with 6 sessions of MIO for each study participant, with the CPP assessment and engagement phase embedded during this time. This phase will be followed by the dyadic mother-child phase, the core intervention stage of CPP. If a parent needs additional stabilization, more individual time can be added. During the core phase of dyadic CPP the Child Parent Specialists will continue to build and strengthen parents' reflective functioning by embedding aspects from MIO.
Participant dyads will be assigned a Certified Recovery Specialists (CRSs) who will provide services to support them as they transition out of SUD treatment and back into their home communities.
干预措施: MIO-CPP-CRS (Behavioral)
结局指标
主要结局
Change in Infant Traumatic Stress Questionnaire (ITSQ)
时间窗: Baseline and 9 months
The ITSQ is an 18-item questionnaire based on 3 of the 4 general criteria for diagnosis of Traumatic Stress Disorder in the Diagnostic Classification: 0-3. The ITSQ is used with children under two. For each tool, the three general criteria sampled were "numbing," "increased arousal," and "fears or aggression." The instruments are completed by parents. The participant responds "Yes" or "No" to each question and scores are summed.
Change in Child Traumatic Stress Questionnaire (CTSQ)
时间窗: Baseline and 9 months
The CTSQ is a 27-item questionnaire based on the criteria for the diagnosis of Traumatic Stress Disorder in the Diagnostic and Statistical Manual of Mental disorders research scale (DSM-IV-RS) and the DC: 0 - 3. The CTSQ with children ages 2 through 4. For each tool, the three general criteria sampled were "numbing," "increased arousal," and "fears or aggression." The instruments are completed by parents. The participant responds "Yes" or "No" to each question and scores are summed.
Change in PSI-SF
时间窗: Baseline and 9 months
The Parenting Stress Index Short Form (PSI-short form), a 36-item symptom inventory designed to identify parent-child dyads experiencing stress and at risk for dysfunctional parenting and behavior problems. It uses 3 categories: parental distress, parent-child dysfunctional interaction, and difficult child.
Change in Infant/Toddler Sensory Profile (ITSP)
时间窗: Baseline and 9 months
The ITSP provides a standard method for professionals to measure a child's sensory processing abilities and to profile the effect of sensory processing on functional performance in the daily life of a child. This instrument is required as part of the cross-site evaluation. The ITSP is a judgment-based caregiver questionnaire. Each item describes children's responses to various sensory experiences. The ITSP consists of 36 items for children - birth to 6 months - and 48 items for children - 7 to 36 months. The questionnaire is available in English and Spanish. The caregiver questionnaire contains items divided into sensory systems. For children birth to 6 months, there are four quadrant scores and one combined quadrant score; for children 7 to 36 months, there are five sensory processing section scores, four quadrant scores, and one combined quadrant score available.
次要结局
- Adult-Adolescent Parenting Inventory (AAPI)(Baseline and 9 months)
- Trauma Symptoms Checklist (TSC-40)(Baseline and 9 months)
- Addiction Severity Index (ASI)(Baseline and 9 months)
- Child Behavior Checklist (CBCL)(Baseline and 9 months)
- Center for Epidemiologic Studies - Depression Scale Short Form (CESD-SF)(Baseline, 3 months, 6 months, and 9 months)
- PC-PTSD-5(Baseline, 3 months, 6 months, and 9 months)
- Keys to Interactive Parenting (KIPS)(Baseline, 3 months, 6 months, and 9 months)
- Parenting Relationship Questionnaire (PRQ)(Baseline and 9 months)
- Parent Development Interview (PDI)(Baseline and 9 months)
- Pregnancy Interview(Baseline)
