Growing Together: A Pragmatic Clinical Trial of a Parenting Intervention for Women in Opioid Treatment and Their Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Coding Interactive Behavior (CIB) system (Observer-rated parent-infant video), measuring Maternal Sensitivity (representing the parent-child relationship)
研究概览
简要总结
This study evaluates the effectiveness of the home-based therapeutic parenting intervention BRIGHT with pregnant women and postpartum mothers with opioid use disorders (OUDs) and their infants. It examines whether participation in the BRIGHT intervention improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, infant social-emotional development and decreases the likelihood of child maltreatment. Approximately half of the participants will receive the BRIGHT intervention, monthly handouts, and the standard of care at the maternal-fetal medical clinic and the other half will receive STAR, or Enhanced Treatment as Usual (TAU+), which includes monthly handouts and the standard of care from the medical clinic.
详细描述
Growing Together is a two-armed pragmatic randomized controlled trial of a trauma and evidence-informed therapeutic parenting intervention, BRIGHT. This trial lasts approximately 9 months.
BRIGHT has been offered to young children ages birth through 6 years and their parents affected by substance use disorders (SUDs) to mitigate the effects of trauma, promote resilience, and enhance the quality of parent-child relationships and parenting skills. BRIGHT has been successfully piloted and evaluated within residential treatment and outpatient opioid treatment programs for pregnant women/mothers with SUDs and OUDs with young children .
For this study, BRIGHT has been adapted for home-based delivery for pregnant women receiving treatment for OUDs and is offered from the 3rd trimester of pregnancy until the infant is about 6 months old. Participants in both arms will be recruited from a high-risk maternal-fetal medicine clinic and followed for approximately 15 months. The two arms of the trial are 1) the BRIGHT (Building Resilience through Intervention, Growing Healthier Together) intervention, and 2) STAR. Both arms of the study will receive the typical standard of care of at a high-risk maternal-fetal medical clinic and 7 monthly psycho-educational handouts on child development specifically for mothers in recovery.
The investigators are testing the effectiveness of the adapted version of BRIGHT by utilizing measures to examine if participation in BRIGHT decreases the likelihood of child maltreatment, improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, and infant social-emotional development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking is used in this clinical trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A patient at BUMC RESPECT clinic with history of opioid use or history of polysubstance use
- •18 years or older
- •Being treated with methadone, naltrexone, or suboxone
- •In 3rd trimester of pregnancy
- •Deemed by MDs able to give informed consent
- •Planning to parent infant after birth
- •Willing to participate in RCT
排除标准
- •Planning to relinquish custody of neonate
- •Residing, or expected to reside post-birth 20+ miles from Boston
- •Deemed by MDs unable to give informed consent
研究组 & 干预措施
STAR/TAU+
The mother receives monthly handouts focused on information about child development and recovery from substance misuse while parenting, along with the standard of care at a high risk maternal-fetal medical clinic.
干预措施: STAR/TAU+ (Other)
BRIGHT
Building Resilience through Intervention: Growing Healthier Together (BRIGHT) weekly home-based intervention from the third trimester of pregnancy through 6 months postpartum. A licensed clinician meets with mother and infant to promote attunement and optimal parent-child interactions. Additionally, the mother receives monthly handouts focused on information about child development and recovery from substance misuse while parenting, along with the standard of care at a high risk maternal-fetal medical clinic
干预措施: BRIGHT (Behavioral)
结局指标
主要结局
Coding Interactive Behavior (CIB) system (Observer-rated parent-infant video), measuring Maternal Sensitivity (representing the parent-child relationship)
时间窗: t1 (6-8 Weeks postpartum), t2 (6-8 months postpartum)
CIB is a rating of mother-child interactions which has three 5-point Likert subscales: Maternal Sensitivity (MSense, primary outcome), Maternal intrusiveness (MIntrude), and Child involvement. (CInvolve). High scores on CIB scales indicate more evidence of the behavior/dimension. Moderate scores typically indicate presence of the behavior/dimension approximately 50% of the time. Low scores indicate that the behavior/dimension is never/infrequently observed. The CIB has been validated with healthy and at-risk populations. The study is assessing the change in CIB score between the time points.
The Adult- Adolescent Parenting Inventory-2 (AAPI), measuring the Risk of Child Maltreatment
时间窗: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
Responses to the inventory provide an index of risk for practicing behaviors known to be attributable to child abuse and neglect. Answers are recorded on a scale from Strongly Agree to Strongly Disagree. Subscales include: Construct A - Inappropriate Expectations of Children, Construct B - Parental Lack of Empathy Towards Children's Needs, Construct C - Strong Parental Belief in the Use of Corporal Punishment, Construct D - Reversing Parent-Child Family Roles, Construct E - Oppressing Children's Power and Independence. 32-item inventory assessing parenting and child-rearing attitudes associated with risk for child maltreatment. Five parenting interaction constructs include, 1) inappropriate expectations for child, 2) empathic awareness of child's needs, 3) belief in corporal punishment, 4) role reversal and 5) oppressing children's power. Construct validity is well-established. Test-re-test reliability is .76. The study is assessing the change in AAPI score between the time points.
次要结局
- Karitane Parenting Confidence Scale (KPCS), measuring Parenting Capacity(t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum))
- Connor-Davidson Resilience Scale-10 (CD-RISC 10), measuring Maternal Mental Health (including continuation of OUD treatment)(t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum))
- Parenting Stress Index/Short Form (PSI/SF), measuring Parenting Capacity(t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum))
- The Brief Symptom Inventory (BSI), measuring Maternal Mental Health (including continuation of OUD treatment)(t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum))
- The Life Stressor Checklist- Revised (LSC-R), measuring Maternal Mental Health (including continuation of OUD treatment)(t0 (3rd trimester))
- The Parental Reflective Functioning Questionnaire (PRFQ), measuring Parenting Capacity(t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum))
- Post Traumatic Stress Disorder Checklist (PCL-5), measuring Maternal Mental Health (including continuation of OUD treatment)(t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum))
- Addiction Severity Index (ASI), measuring Maternal Mental Health (including continuation of OUD treatment)(t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum))
- Devereaux Early Childhood Assessment for Infants and Toddlers (DECA-I/T), measuring Infant Social-Emotional Development(t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum))
- Parent Development Interview (PDI)- Short Form Revised 2016, measuring Parental Reflective Functioning(t0 (3rd trimester), t2 (6-8 months postpartum))
研究者
Ruth Paris
Associate Professor
Boston University Charles River Campus