Clinical trial NCT04853888: ATTACH™ Program: Promoting Vulnerable Children's Health at Scale
Official title: Attachment and Child Health (ATTACH™) Program: Promoting Vulnerable Children's Health at Scale
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Keywords: Parent Child Interaction Quality
Parental Reflective Function
Child Development
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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™).

In finalizing the interview guide and developing the interview processes (e.g. home or clinic setting, telephone/web-conference, Zoom or in-person), the Patient Engagement Committee (PEC) and Community Engagement Committee (CEC) members will be engaged in review, feedback and decision making. The interview guide will be used for staff and patients and will be pilot tested before use. Interviews will be audio-recorded and transcribed verbatim with appropriate privacy protections in place to guard participant identity and personal information. Data analysis will occur in two parts. First, interviews will be transcribed and coded as soon as interviews are completed and examined for "nuggets" or key learnings that offer guidance to implementation in agencies. These nuggets will be shared with the Executive Team, PEC and CEC (especially relevant agency health care professionals and administrators) and discussed so that appropriate adjustments may be made to facilitate ATTACH™ normalization in agencies. Second, all transcripts will be coded using the stages of thematic analysis including familiarization, coding, theme development and data reporting. Theme and sub-theme development will be deductive, using a priori codes dictated by interview questions in order to explain factors that promote or inhibit interventions from being embedded in agency practice. As new interviews are undertaken, data will be examined to determine degree of data saturation. Two trainees will code the data, supervised by Letourneau, who is experienced in qualitative data analysis. Inter-rater reliability will be assessed and reported with Cohen's kappa coefficients; disagreements will be resolved by consensus. Data will be managed with QSR International NVivo12. Once themes and sub-themes are finalized, findings will be summarized in a draft report and shared with key informants as a validation check.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

-

Primary outcomes:
measure: Parent-Child Relationship Quality will be measured by Parent Child Interaction Teaching Scale (PCITS).
timeFrame: Change from baseline PCITS scores after completion of intervention and at 3 months.
Secondary outcomes:
measure: Parental Reflective Function will be measured by Parental Reflective Function Questionnaire (PRFQ).
timeFrame: Change from baseline PRFQ scores after completion of intervention and at 3 months.
measure: Child Development, measured by Ages and Stages Questionnaire - 3rd Edition
timeFrame: Change from baseline ASQ-3 scores after completion of intervention and at 3 months.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Nicole Letourneau, PhD RN FCAHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anis L, Letourneau N, Ross KM, Hart M, Graham I, Lalonde S, Varro S, Baldwin A, Soulsby A, Majnemer A, Donnelly C, Piotrowski C, Collier C, Lindeman C, Goldowitz D, Isaac D, Thomson D, Serre D, Citro E, Zimmermann G, Pliszka H, Mann J, Baumann J, Piekarski J, Dalton JA, Johnson-Green J, Wood K, Bruce M, Santana M, Mayer M, Gould M, Kobor M, Flowers M, Haywood M, Koerner M, Parker N, Muhajarine N, Fairie P, Chrishti R, Perry R, Merrill S, Pociuk S, StephanieTaylor, Cole S, Murphy T, Marchment T, Xavier V, Shajani Z, West Z. Study protocol for Attachment & Child Health (ATTACHTM) program: promoting vulnerable Children's health at scale. BMC Pediatr. 2022 Aug 19;22(1):491. doi: 10.1186/s12887-022-03439-3.