Adaptation and Pilot Testing of Web and Mobile Interface for the ATTACH™ Intervention

NCT04857775 | Recruiting

• 1 other identifier: REB14-0368
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mother Child interaction Quality will be assessed by Parent Child Interaction Teaching Scale (PCITS)

  The Parent Child Interaction Teaching Scale will be used to evaluate Mother-child interactions. See Study Detailed Description and Intervention arm for more information on the PCITS Program. Scale range from 0 - 73. A higher score means a better outcome, i.e. higher quality of parent-child interaction.

  Change from baseline PCITS scores after completion of intervention (an average of 10 weeks).

Study Arms (1)

Intervention group

EXPERIMENTAL

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.

Behavioral: Attachment and Child Health (ATTACH) Parenting Program

Interventions

Attachment and Child Health (ATTACH) Parenting Program BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Behavior, Addictive

Interventions

Child Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 23, 2021
• Study Start: March 15, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)