Attachment and Child Health (ATTACH™) Program: Promoting Vulnerable Children's Health at Scale
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Parent-Child Relationship Quality will be measured by Parent Child Interaction Teaching Scale (PCITS).
研究概览
简要总结
ATTACH™ is a psycho-educational parenting program, designed with community agencies serving families of preschoolers affected by toxic stress (e.g. parental depression, addictions, domestic violence, poverty) to bolster children's health and development. It focuses on improving parent-child relationship quality by targeting parents' reflective function (RF), i.e. the ability to better understand one's own and one's child's thoughts and feelings. RF is essential for high quality parent-child relationships and secure attachment, both tied to child development and health, especially cognition, communication and inflammation. ATTACH™ was implemented and tested in seven rapid-cycling pilot studies by researchers, guided by the IDEAS (Innovate, Develop, Evaluate, Adapt, Scale) Framework™, an innovative clinical trial approach. ATTACH™ significantly improved: (a) parent-child relationship quality and attachment, (b) parents' RF scores, and (c) children's cognitive and motor development. However, whether ATTACH™ continues to work with delivery by trained agency healthcare professionals rather than study researchers, in naturalistic, community settings remains to be seen. Small sample sizes also limited the ability to assess longer-term impacts and whether ATTACH™ is equally effective across patient populations. Further, another parenting intervention successfully reduced systemic inflammation in children exposed to toxic stress. Whether ATTACH™ impacts novel biomarkers of inflammation (i.e. immune cell gene expression and DNA methylation) is not known.
详细描述
Methods: This study is comprised of a pre/ post-test quasi-experimental design evaluation of the ATTACH™ program as well as an examination of implementation feasibility via Normalization Process Theory (NPT). While Objective 1 will be addressed first, Objective 2 will begin soon after so that information gathered in Objective 2 may be used to tailor the implementation in Objective 1 as appropriate.
Research Question & Objectives: The proposed research has the following two (quantitative and qualitative) arms: Objective 1 (Quantitative component): To evaluate community agencies delivered ATTACH™ impacts on: (1a) parent-child relationship quality, parental RF and child development, (1b) different patient populations (for whom program works best/worst), (1c) immune biomarkers indicative of inflammatory disease risk, i.e. gene expression and DNA methylation, (1d) health professionals' adherence to ATTACH™ program, via fidelity assessment, and (1e) outcomes 3 months post-intervention. Objective 2 (Qualitative component): To evaluate health care professionals' and administrators' perceptions and experiences of: (2a) intervention uptake and fidelity, (2b) implementation benefits, facilitators, barriers and challenges, and (2c) utility of ATTACH™ e-learning platform. The study participants can not be enrolled in the program without being in the research.
Objective 1: A quasi-experimental design was selected to more closely approximate service delivery models in agencies that do not typically employ control groups. We will intervene with 100 new patients and their birth to 36 month-old children, a sufficient sample size to detect minimum effect size (d=.34) for pre-intervention/post-intervention differences from the primary outcome of parent-child relationship quality, from the five community agencies. We plan to recruit 20 families (including parents, co-parents and children) from each agency.
Objective 2: NPT is used to uncover factors that interfere with the routine incorporation of interventions into health care. Thus, NPT is the ideal theory to guide our approaches including qualitative semi-structured interviews and analyses. NPT will enable the exploration of patients', health care professionals' and health system administrators' perceptions and experiences of intervention uptake and fidelity as well as the benefits, facilitators, barriers and challenges to ATTACH™ implementation by community agencies, including perceptions of the fidelity assessment tool and e-learning training.
Setting: Settings include Alcove Addiction Recovery, CUPS Calgary, Discovery House Women's Shelter, Sonshine Community Centre, and Steinbach Family Resource Centre, MB. Other interested agencies will also be involved. Patients, health care professionals and administrators from each agency will be recruited via convenience sampling methods to take part in one-on-one interviews. We plan to recruit 20 patients, 20 health care professionals and 20 administrators (total n= 60) at the participating agencies. However recruitment and data collection will continue until theoretical data saturation, i.e. the degree to which new data repeats or is redundant with what was expressed in previous data. We will employ a stopping rule: Data collection in a category (patient, health care professional, and health care administrator) will cease when three interviews in a row offer less than 5% new information. Only deidentified data will be sent by the participating agencies. Basic demographic data will be collected from stakeholders (patients, health care professionals, and administrators), including age, sex, employment and education. Using NPT in implementing complex interventions like ATTACH™, requires development of an interview guide addressing the four NPT concepts: coherence (meaning and sense making of ATTACH™ by participants), cognitive participation (commitment and engagement by participants), collective action (work the participants do to make ATTACH™ function), and reflexive monitoring (reflection of ATTACH™).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •parents with children between birth and 32 months of age (based on selection of age-appropriate tools for assessing children's health and development)
- •parents agree to participate in the ATTACH™ program consisting of 10-12 weeks of one-hour per week parent training sessions
- •parents agreed to bring a co-parent for 2-3 of the 10 sessions (when possible)
- •parents agree to the dried blood sample collection from themselves and their children (in Calgary agencies)
排除标准
- 未提供
结局指标
主要结局
Parent-Child Relationship Quality will be measured by Parent Child Interaction Teaching Scale (PCITS).
时间窗: Change from baseline PCITS scores after completion of intervention and at 3 months.
The PCITS scale (Sumner \& Spietz, 1994) is an observational binary measure of interactions in parent-child teaching situations to measure parent-child interaction quality in infants 36 months or younger. Considered as the gold standard, PCITS consists of 73 items categorized into 6 subscales including parental sensitivity to cues, responsiveness to distress, growth fostering, and cognitive growth fostering, and infant clarity of cues and responsiveness to parent. Certified coders code the items either as yes or no; Yes responses are then summed to yield a total score for each sub-scale. Final PCITS scores include total scores for each subscale, parent total, child total, and parent-child total scores, along with total parent contingency and child contingency scores. The observation of teaching interaction typically takes 5 minutes. Scale range from 0 - 73. A higher score means a better outcome, i.e. higher quality of parent-child interaction.
次要结局
- Parental Reflective Function will be measured by Parental Reflective Function Questionnaire (PRFQ).(Change from baseline PRFQ scores after completion of intervention and at 3 months.)
- Child Development, measured by Ages and Stages Questionnaire - 3rd Edition(Change from baseline ASQ-3 scores after completion of intervention and at 3 months.)
研究者
Nicole Letourneau
Chair in Parent-Infant Mental Health. Professor, Faculty of Nursing & Cumming School of Medicine (Pediatrics, Psychiatry & Community Health Sciences), Director of RESOLVE Alberta
University of Calgary