Study protocol for Attachment & Child Health (ATTACHTM) program: promoting vulnerable Children’s health at scale

Abstract

Background Children’s exposure to toxic stress (e.g., parental depression, violence, poverty) predicts developmental and physical health problems resulting in health care system burden. Supporting parents to develop parenting skills can buffer the effects of toxic stress, leading to healthier outcomes for those children. Parenting interventions that focus on promoting parental reflective function (RF), i.e., parents’ capacity for insight into their child’s and their own thoughts, feelings, and mental states, may understand help reduce societal health inequities stemming from childhood stress exposures. The Attachment and Child Health (ATTACHTM) program has been implemented and tested in seven rapid-cycling pilot studies (n = 64) and found to significantly improve parents’ RF in the domains of attachment, parenting quality, immune function, and children’s cognitive and motor development. The purpose of the study is to conduct an effectiveness-implementation hybrid (EIH) Type II study of ATTACHTM to assess its impacts in naturalistic, real-world settings delivered by community agencies rather than researchers under more controlled conditions. Methods The study is comprised of a quantitative pre/post-test quasi-experimental evaluation of the ATTACHTM program, and a qualitative examination of implementation feasibility using thematic analysis via Normalization Process Theory (NPT). We will work with 100 families and their children (birth to 36-months-old). Study outcomes include: the Parent Child Interaction Teaching Scale to assess parent-child interaction; the Parental Reflective Function and Reflective Function Questionnaires to assess RF; and the Ages and Stages Questionnaire – 3rd edition to examine child development, all administered pre-, post-, and 3-month-delayed post-assessment. Blood samples will be collected pre- and post- assessment to assess immune biomarkers. Further, we will conduct one-on-one interviews with study participants, health and social service providers, and administrators (total n = 60) from each collaborating agency, using NPT to explore perceptions and experiences of intervention uptake, the fidelity assessment tool and e-learning training as well as the benefits, barriers, and challenges to ATTACHTM implementation. Discussion The proposed study will assess effectiveness and implementation to help understand the delivery of ATTACHTM in community agencies. Trial registration Name of registry: https://clinicaltrials.gov/. Registration number: NCT04853888. Date of registration: April 22, 2021.

Study Protocol for Assessing the Effectiveness, Implementation Fidelity and Uptake of Attachment & Child Health (ATTACHTM) Online: Helping Children Vulnerable to Early Adversity

“…Because this is a social intervention, not a drug or pharmaceutical trial, there is no data monitoring committee or interim analysis (Anis, Letourneau, et al, 2022).…”

“…A quasi-experimental design was selected to more closely approximates service delivery models in agencies that do not typically employ control groups. Moreover, given signi cant differences in randomized controlled trials and quasi-experimental pilot studies Anis, Ross, et al, 2022), any design employing wait-list controls was deemed unacceptable and even unethical by the team including parents, health care professionals, and administrators from engagement activities during the preparation of this proposal. A step-wedge design (Hemming et al, 2015)was also ruled out due to concerns with undue delays in receiving the ATTACH™ Online program.…”

“…This is based on power of .90, and two-tailed alpha (p<.05/3=.0167, given Bonferroni correction applied for separate comparisons using three developmental outcomes). Pilot data from the in-person ATTACH™ program tests revealed relevant effect sizes for child development, ranging from d=.44-.98 for communication, personal social, problemsolving skills Anis, Ross, et al, 2022;Letourneau et al, 2023). Thus, eighty complete participant family data sets will be su cient to detect conservatively moderate effect sizes for within group differences (d=.44) for each of the three developmental outcomes (communication, personal-social, problem-solving) between pre-intervention and immediately post-intervention.…”

“…As ATTACH TM is a social intervention rather than a drug or pharmaceutical trial, there is no data auditing (Anis, Letourneau, et al, 2022).…”

Developmental Brain Injury and Social Determinants of Health: Opportunities to Combine Preclinical Models for Mechanistic Insights into Recovery

“…While these improvements are likely mediated through mechanisms such as better access to medical appointments and environmental enrichments, the direct effects of parental education may also play a role. There is ongoing research as to whether education for parents on interventions focused on improving childhood attachment can ameliorate some effects of childhood toxic stress [32] .…”