ATTACH™ Online Platform: Helping Children Vulnerable to Early Adversity (ATTACH™)

August 29, 2023 updated by: Nicole Letourneau, University of Calgary

Attachment & Child Health (ATTACH™) Online Platform: Helping Children Vulnerable to Early Adversity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Methods: This effectiveness-implementation hybrid (EIH) Type II study is an innovative clinical trial comprised of a quasi-experimental design evaluation of the community-agency delivered ATTACH™ Online platform (with measurement pre-intervention, immediately post-intervention, and three months postintervention) as well as an examination of implementation feasibility via Normalization Process Theory. Investigators will work with 100 parents and children (aged newborn to 36 months).

Objective 1: Employing innovative clinical trial quasi-experimental methods, the effectiveness of the ATTACH™ Online platform will be evaluated on: (1a) children's mental health and development (primary outcome), parent-child relationship quality, and parental reflective function (secondary outcomes) immediately and three months after the intervention, (1b) different patient populations (for whom the program works best/worst), and (1c) health professionals' adherence to the clinical intervention protocol via fidelity assessment. For these objectives, investigators will intervene with 100 new families, a sufficiently powered n to detect minimum d=.5 (from pilot data and accounting for attrition) for pre-intervention/post-intervention differences in children's mental health and development.

Objective 2: Using qualitative methods, the feasibility of implementation of the ATTACH™ Online platform will be evaluated via (2a) knowledge of users' (patients/parents, health care professionals, and administrators) perceptions and experiences of the ATTACH™ Online platform, (2b) ATTACH™ Online platform uptake, and (2c) ATTACH™ Online platform implementation benefits, facilitators, barriers, and challenges. For these objectives, investigators will interview knowledge users (patients/parents, health care professionals, and administrators (n≈60)) until data saturation using Normalization Process Theory.

Study Setting： include 10 Alberta agencies (technically 9, as one agency operates two shelters) serving culturally diverse clients (i.e., Caucasian as well as Black, Indigenous, People of Colour; BIPOC) and immigrants affected by family violence, depression, and low-income. The agencies including Brenda Strafford Centre, Catholic Social Services, Children, Families, and Community Services, Central Alberta Women's Emergency Shelter, Discovery House (Women's Shelter), Highbanks, Home Next Door*, Hull Social Services, Julietta's Place, La Salle Second Stage Shelter, Catholic Social Services and WINGS of Providence.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Recruiting
        • University of Calgary
        • Contact:
        • Contact:
          • Martha Hart, PhD
          • Phone Number: 403-681-3592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Mental Health and Development
Time Frame: Change from baseline ASQ-3 scores immediately after completion of intervention and at 3 months.
The Ages and Stages Questionnaire 3rd Edition (ASQ - 3) is a series of parent-completed questionnaires to assess child development in 5 domains namely communication, gross motor, fine motor, problem-solving, and personal-social skills. There are 21 versions for different age groups 21 ranging from 1 to 66 months, with 6 questions in each domain asking if the child can or cannot do age-appropriate tasks. Adding up items in each domain provides a total score for that domain. Summing up the total scores for each domain yields the total score (out of 60). Scores range from 0-60 and higher scores are indicative of healthier outcomes.
Change from baseline ASQ-3 scores immediately after completion of intervention and at 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-Child Relationship Quality
Time Frame: Change from baseline PCITS scores immediately after completion of intervention and at 3 months.
The Parent Child Interaction Teaching Scale (PCITS) is an observational binary measure of interactions in parent-child teaching situations to measure parent-child interaction quality in infants 36 months or younger. Considered as the gold standard, PCITS consists of 73 items categorized into 6 subscales including parental sensitivity to cues, responsiveness to distress, growth fostering, and cognitive growth fostering, and infant clarity of cues and responsiveness to parent. Certified coders code the items either as yes or no; Yes responses are then summed to yield a total score for each sub-scale. Final PCITS scores include total scores for each subscale, parent total, child total, and parent-child total scores, along with total parent contingency and child contingency scores. The observation of teaching interaction typically takes 5 minutes. 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 immediately after completion of intervention and at 3 months.
Parental Reflective Function (RF)
Time Frame: Change from baseline PRFQ scores immediately after completion of intervention and at 3 months.
The Parental Reflective Function Questionnaire (PRFQ) is an 18-item measure of parental RF, with subscales assessing: (a) Pre-mentalizing subscale, (b) Certainty in Mental States subscale, and (c) Interest and Curiosity subscale. Scores from each sub-scale range from 1 to 7. Higher scores indicate higher levels of parental RF. The PRFQ has good internal consistency (.7-.84) and takes 5 minutes to complete. Pilot testing revealed the PRFQ detected intervention impacts and was acceptable to patients. In our other work, investigators show that scores on the PRFQ associate significantly (p<.05) with the gold standard Parental Development Interview coded with Fonagy's 11-point scale. Given the gold standard requires 1-2 hours per patient interview, followed by 1 hour to check automated transcriptions, and 3 hours of coding per interview (~6 hours total), the use of the PRFQ reduces patient burden, costs and is feasible to implement in agencies.
Change from baseline PRFQ scores immediately after completion of intervention and at 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Nicole Letourneau, PhD RN, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

July 22, 2023

First Submitted That Met QC Criteria

August 12, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REB20-0903-Online

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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