ATTACH™ Online Platform: Helping Children Vulnerable to Early Adversity

NCT05994027 | Unknown

• 1 other identifier: REB20-0903-Online
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Children's Mental Health and Development

  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 Outcomes (2)

• Parent-Child Relationship Quality

  Change from baseline PCITS scores immediately after completion of intervention and at 3 months.

• Parental Reflective Function (RF)

  Change from baseline PRFQ scores immediately after completion of intervention and at 3 months.

Study Arms (1)

ATTACH™ Online Platform Parenting Program

OTHER

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

Interventions

ATTACH™ Online Platform Parenting Program BEHAVIORAL

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.

ATTACH™ Online Platform Parenting Program

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 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).

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Related Publications (11)

• Anis L, Letourneau N, Benzies K, Ewashen C, Hart MJ. Effect of the Attachment and Child Health Parent Training Program on Parent-Child Interaction Quality and Child Development. Can J Nurs Res. 2020 Jun;52(2):157-168. doi: 10.1177/0844562119899004. Epub 2020 Jan 30.

  PMID: 32000509 BACKGROUND

• Ross KM, Cole S, Sanghera H, Anis L, Hart M, Letourneau N. The ATTACH program and immune cell gene expression profiles in mothers and children: A pilot randomized controlled trial. Brain Behav Immun Health. 2021 Oct 2;18:100358. doi: 10.1016/j.bbih.2021.100358. eCollection 2021 Dec.

  PMID: 34647106 RESULT

• Letourneau N, Anis L, Novick J, Pohl C, Ntanda H, Hart M. Impacts of the Attachment and Child Health (ATTACHTM) Parenting Program on Mothers and Their Children at Risk of Maltreatment: Phase 2 Results. Int J Environ Res Public Health. 2023 Feb 9;20(4):3078. doi: 10.3390/ijerph20043078.

  PMID: 36833770 RESULT

• 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.

  PMID: 35986306 RESULT

• Letourneau N, Anis L, Ntanda H, Novick J, Steele M, Steele H, Hart M. Attachment & Child Health (ATTACH) pilot trials: Effect of parental reflective function intervention for families affected by toxic stress. Infant Ment Health J. 2020 Jul;41(4):445-462. doi: 10.1002/imhj.21833. Epub 2020 Jun 13.

  PMID: 32533796 RESULT

• Anis L, Ross K, Ntanda H, Hart M, Letourneau N. Effect of Attachment and Child Health (ATTACHTM) Parenting Program on Parent-Infant Attachment, Parental Reflective Function, and Parental Depression. Int J Environ Res Public Health. 2022 Jul 10;19(14):8425. doi: 10.3390/ijerph19148425.

  PMID: 35886276 RESULT

• Squires J, Bricker D, Potter L. Revision of a parent-completed development screening tool: Ages and Stages Questionnaires. J Pediatr Psychol. 1997 Jun;22(3):313-28. doi: 10.1093/jpepsy/22.3.313.

  PMID: 9212550 RESULT

• Luyten P, Mayes LC, Nijssens L, Fonagy P. The parental reflective functioning questionnaire: Development and preliminary validation. PLoS One. 2017 May 4;12(5):e0176218. doi: 10.1371/journal.pone.0176218. eCollection 2017.

  PMID: 28472162 RESULT

• Letourneau NL, Tryphonopoulos PD, Novick J, Hart JM, Giesbrecht G, Oxford ML. Nursing Child Assessment Satellite Training Parent-Child Interaction Scales: Comparing American and Canadian Normative and High-Risk Samples. J Pediatr Nurs. 2018 May-Jun;40:47-57. doi: 10.1016/j.pedn.2018.02.016. Epub 2018 Mar 22.

  PMID: 29776479 RESULT

• Anis L, Benzies KM, Ewashen C, Hart MJ, Letourneau N. Fidelity Assessment Checklist Development for Community Nursing Research in Early Childhood. Front Public Health. 2021 May 14;9:582950. doi: 10.3389/fpubh.2021.582950. eCollection 2021.

  PMID: 34055705 RESULT

• Letourneau N, Anis L, Cui C, Graham ID, Ross K, Nixon K, Reimer J, Pilipchuk M, Wang E, Lalonde S, Varro S, Santana MJ, Stewart-Tufescu A, Soulsby A, Tiedemann B, Hill L, Beks T, Hart M. Study protocol for assessing the effectiveness, implementation fidelity and uptake of attachment & child health (ATTACH) Online: helping children vulnerable to early adversity. BMC Pediatr. 2025 Apr 9;25(1):280. doi: 10.1186/s12887-024-05232-w.

  PMID: 40205561 DERIVED

Study Officials

• Nicole Letourneau, PhD RN

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Letourneau, PhD RN

CONTACT

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

Martha Hart, PhD

CONTACT

403-441-4566; mhart@ucalgary.ca

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: Chair in Parent-Infant Mental Health. Professor, Faculty of Nursing & Cumming School of Medicine (Pediatrics, Psychiatry & Community Health Sciences), Director of RESOLVE Alberta

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: August 16, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)