Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The number of intervention sessions completed by mothers
研究概览
简要总结
This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to postpartum women with substance use disorder. This study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. We will also identify key implementation domains that impact successful delivery. We hypothesize that the intervention will be feasible and acceptable to the study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •English speaking
- •18 years of age or older
- •Mother to an index child between birth and 2 years old at the time of estimated start of intervention delivery
- •Engaged in formal recovery supports (including but not limited to: Recovery Coaches, support groups specific to people in recovery, medication assisted treatment) at time of enrollment for a minimum 3 months
- •Willing to receive parenting supports for the index child through EI
- •Geographically based within the catchment area of participating EI programs
排除标准
- •Severe mental health problems (suicidal, homicidal, psychosis episodes within the past year)
- •Significant cognitive impairment (unable to give informed consent)
- •Has an index child that has complex medical problems that significantly impact the child's ability to interact with the parent (e.g. blindness, deafness, severe weakness, or paralysis)
结局指标
主要结局
The number of intervention sessions completed by mothers
时间窗: Through intervention period, an average of 6 months
The total number of sessions completed
Early Intervention and additional services received by mothers after intervention period
时间窗: Post-intervention up to 3 months
Services received qualitatively listed by mothers
Qualitative perceptions of intervention sessions from mothers
时间窗: Through intervention period, an average of 6 months
Open-ended feedback of intervention sessions
Qualitative perceptions of intervention sessions from mothers after intervention period
时间窗: 3 months after the completion of the intervention
Open-ended feedback via a 30-minute interview
Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale
时间窗: Through intervention period for each mother participant, an average of 6 months
The revised Mothering from the Inside Out (MIO) Adherence Rating Scale is a 9-item measure rated on a 3-point scale for frequency of occurrence (never or seldom, sporadically, or consistent) and competence (poorly executed, adequately executed, or well-executed) of intervention delivery. The measure uses intervention session audio- or video- recordings and includes MIO specific fidelity and a measure of therapeutic alliance.
Recruitment and enrollment
时间窗: Through study completion up to 3 months
The number of mothers referred, approached, and enrolled in the study
The number of supervision sessions completed by providers
时间窗: Through intervention period for each mother participant, an average of 6 months
The total number of sessions completed
Number of Early Intervention services received
时间窗: Through intervention period, an average of 6 months
All Early Intervention services received by mothers and their child(ren)
Retention of study participants
时间窗: Through study completion up to 3 months
Time to loss of follow-up and perceived reason for discontinuation
Qualitative perceptions of intervention sessions from Early Intervention providers
时间窗: Through intervention period for each mother participant, an average of 6 months
Open-ended feedback of intervention sessions
Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period
时间窗: Post-intervention for each mother participant up to 3 months
Open-ended feedback via a 30-minute interview
The duration of intervention sessions
时间窗: Through intervention period, an average of 6 months
Session duration in minutes
Mothers' perceived barriers and facilitators to intervention delivery
时间窗: Through intervention period, an average of 6 months
Qualitative perceptions of intervention logistics
次要结局
- Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual(0, 3, 6 months)
- Changes in parental reflective functioning according to the Parent Development Interview (PDI)(0, 3, and 6 months)
研究者
Elizabeth Peacock-Chambers, MD
Assistant Professor
Baystate Medical Center