Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05994027

Conditions

Parent-Child Relations

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

ATTACH™ Online Platform Parenting Program

Study Details

Brief summary:

Addressing the impact of early childhood adversity (e.g., family violence, parental depression, and low income) can promote children's mental health and development, giving children the best start in life and reducing societal health inequities. Family violence, depression, and low income undermine parent-child relationship quality linked to mental health and developmental problems in children that tend to persist over the lifespan. Parents' reflective function (RF), i.e., the capacity to understand their own and their child's thoughts, feelings, and mental states, can strengthen parent-child relationships and buffer the negative impacts of early adversity on children. Investigators have developed and tested an effective intervention program called ATTACH™ (Attachment and Child Health) for parents and their preschool-aged children at-risk of early adversity. In research with 90 families, investigators found the intervention significantly improved RF, parent-child relationship quality, and children's mental health and development. When COVID-19 prevented in-person intervention at the same time as demand soared for ATTACH™, investigators developed and pilot tested (n=10) an Online platform or "platform" with our community partners, including parents, to deliver the program virtually. The purpose of the study is to propose an effective implementation hybrid (EIH) Type II study of the ATTACH™ Online platform. Co-primary objectives evaluate clinical intervention effectiveness and implementation strategy feasibility of the ATTACH™ Online platform in naturalistic, real-world settings delivered by community partner agencies serving families affected by early adversity in Alberta.

Conditions

Parent-Child Relations

Study ID

NCT05994027

Start date

Oct 1, 2022

Status verified date

Aug, 2023

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Oct 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • parents with children between birth to 32 months of age (our age ceiling is 36 months, based on selection of age-platformropriate tools for assessing children's health and development );
  • parents who agree to participate in the ATTACH™ Online platform program consisting of 10 weeks of additional, concurrent, one-hour per week parent training sessions;
  • parents who agree to bring a co-parent for 2 of the 10 sessions (when possible).

Exclusion Criteria:

-

Study Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: ATTACH™ Online Platform Parenting Program

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, healthcare professionals, and health system administrators in engagement activities surrounding the preparation of this proposal.

Interventions

ATTACH™ Online Platform Parenting Program

ATTACH Online Platform: Preserving and promoting optimal RF in parents who are experiencing adversities, enables parents to appropriately attribute affective states to their children and respond accurately to meet their children's needs, thus promoting sensitive/ responsive parent-child relationships.

Primary outcome measure

  • Children's Mental Health and Development [ Time Frame: Change from baseline ASQ-3 scores immediately after completion of intervention and at 3 months. ]

Central Contacts and Locations

Central contacts

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Martha Hart, PhD

403-681-3592

More Information

Sponsor

University of Calgary

Last update posted

Sep 1, 2023

Last verified

Aug, 2023

Keywords

  • Parent Child Interaction Quality
  • Parental Reflective Function
  • Child Development
  • Online platform

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 2023-09-01.