Recruiting

ATTACH™

Sponsor:

University of Calgary

Code:

NCT04857775

Conditions

Depression

Addiction

Domestic Violence

Poverty

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Attachment and Child Health (ATTACH) Parenting Program

Study Details

Brief summary:

COVID-19 has placed unprecedented strains on parents impacted by toxic stressors (depression, addiction, family violence, and poverty) and reluctant to see mental health-service providers in home/clinic due to fears of infection. Due to the pandemic, PI Letourneau ceased/delayed recruitment in ATTACH™, a CIHR-funded randomized controlled trials (RCT) of in-person (home or clinic) program designed to improve children's mental, emotional and behavioral (MEB) health and development via parent-child relationship intervention. Recognizing the heightened need for already vulnerable families to obtain safe parenting support to manage depressive symptoms/other stressors. The team's primary knowledge user (D. McNeil, Scientific Director, Maternal Newborn Child and Youth Strategic Clinical Network, Alberta Health Services) advocated for online delivery of the ATTACH™ parent training program. In response, an interdisciplinary team from nursing and software engineering rapidly pivoted to an online delivery format. Critical barriers to using existing commercial technologies emerged, making it essential to develop and implement tailored, user-informed virtual care delivery platforms and tools safe, secure, user-friendly for families already stressed. Innovative user interface design and integrated knowledge transfer approaches will be used to: (a) adapt ATTACH™ for virtual delivery; (b) develop virtual platforms (web-based applications) and tools (mobile apps) for flexible delivery of mental health supports for parents and training for professional facilitators; (c) integrate virtual mental health services into the primary care system promoting program uptake; and (d) design/test streamlined and intuitive virtual systems for nimble spread/scaleup. The project catalyzes and enriches the PIs' research program by crossing disciplines (nursing \& engineering) in cutting edge research that is responsive to trends in both mental health intervention and web-interface design. The aim is to adapt, develop, design and pilot test virtual (web-based) intervention program to improve children's mental, emotional and behavioral (MEB) health and development. This will be done by building on successful CIHR funded in-person (home or clinic) programs and pivoting to user-engaged program development, adaptation and pilot testing for virtual delivery in the face of COVID19.

Conditions

Depression

Addiction

Domestic Violence

Poverty

Study ID

NCT04857775

Start date

Mar 15, 2021

Status verified date

May, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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:

-

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention group

A quasi-experimental design was selected to more closely approximate service delivery models in agencies that do not typically employ control groups. Given promising findings (from seven ATTACH™ pilot studies), a randomized controlled trial design, even employing wait-list controls was deemed unacceptable and even unethical by patients, health care professionals and health system administrators in engagement activities surrounding the preparation of this proposal.

Interventions

Attachment and Child Health (ATTACH) Parenting Program

ATTACH™ provides parent training to address Reflective Function (RF) of parents affected by a broad array of toxic stressors. RF, defined as the ability to have insight into one's own and one's child's mental states, feelings, thoughts and intentions, underpins parental sensitivity and responsiveness and is undermined by the experience of current or past stress. Parents require high RF to respond sensitively/appropriately to their children and thus promote secure parent-child attachments, essential for child MEB health. ATTACH™ consists of 10-12 \~45-minute clinic visits with dyadic (mother and infant) and triadic (mother, infant, and co-parent) elements, with a trained facilitator, who may be a nurse, social worker or other allied health professional.

Primary outcome measure

  • Mother Child interaction Quality will be assessed by Parent Child Interaction Teaching Scale (PCITS) [ Time Frame: Change from baseline PCITS scores after completion of intervention (an average of 10 weeks). ]

Central Contacts and Locations

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Nicole Letourneau, RN, PhD

403-210-3833nicole.letourneau@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

May 10, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-05-10.