ATTACH™ Virtual Parenting Program for Children's Mental Health

(ATTACH™ Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the ATTACH™ Parenting Program treatment?

Research on similar attachment-based parenting programs, like the Lighthouse Parenting Program and video-feedback interventions, shows they can improve parent-child relationships and reduce stress in families with mental health challenges. These programs have been positively evaluated for enhancing parental sensitivity and child attachment security, suggesting potential benefits for the ATTACH™ Parenting Program as well. ^{1 2 3 4 5}

Is the ATTACH™ Virtual Parenting Program safe for participants?

The ATTACH™ Parenting Program has been tested in several pilot studies and has shown improvements in parenting skills and child development without any reported safety concerns. It is designed to help parents manage stress and improve their relationship with their children, which suggests it is generally safe for participants. ^{6 7 8 9 10}

How is the ATTACH™ Parenting Program treatment different from other treatments for children's mental health?

The ATTACH™ Parenting Program is unique because it focuses on enhancing parental reflective function, which helps parents understand their own and their child's thoughts and feelings, potentially reducing the impact of toxic stress on children's development. This approach is delivered in real-world settings by community agencies, making it accessible and practical for families dealing with stressors like parental depression and poverty. ^{6 11 12 13 14}

Eligibility Criteria

This trial is for parents with children aged between birth and 32 months who are willing to participate in a 10-12 week parenting program. They must commit to one-hour weekly sessions, involve a co-parent for some sessions if possible, and consent to dried blood sample collection from themselves and their children at Calgary agencies.

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)

Exclusion Criteria

None

Timeline

Exploratory

User engagement to identify content and explore design challenges and user preferences, followed by prototyping of interface designs

3-4 weeks

Weekly design sessions via Zoom

Software Development

Iterative design sessions with users to develop minimum viable products (MVPs)

3-4 weeks

Weekly design sessions via Zoom

Pilot Test

Beta test MVPs and refine user interface designs based on user feedback

10 weeks

Sessions with parents from Discovery House and CUPS

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

Treatment Details

Interventions

• ATTACH™ Parenting Program

Trial Overview The ATTACH™ Parenting Program is being adapted for online delivery due to COVID-19. The study will develop web-based applications and mobile apps aimed at improving the mental, emotional, and behavioral health of children by supporting parents through virtual training.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

The 8-week video-feedback intervention program effectively enhances parental sensitivity and improves child attachment security among maltreating parents and their children aged 1 to 5 years.

This program is the first short-term attachment-based intervention to show a reduction in disorganized attachment in families reported for child abuse and/or neglect, highlighting its potential as a valuable therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-feedback intervention with maltreating parents and their children: program implementation and case study. Moss, E., Tarabulsy, GM., St-Georges, R., et al.[2014]

The Mom Power (MP) program, a 13-session intervention for high-risk mothers and their young children, showed promise in improving maternal mental health by significantly reducing depression and PTSD symptoms among participants, particularly those with pre-existing mental health diagnoses.

Participation in the MP program was associated with improved parenting competence, with a notable dose-response effect indicating that mothers who attended at least 70% of the sessions experienced greater benefits compared to those who attended fewer sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers. Muzik, M., Rosenblum, KL., Alfafara, EA., et al.[2019]

The study implemented Video Intervention Therapy (VIT) to enhance Parental Reflective Functioning (PRF) in caregivers of children hospitalized for severe psychiatric issues, showing that the intervention was feasible and well-accepted by participants and therapists.

With a compliance rate of 85% in the VIT group and positive indications for improving both parental and child mental health outcomes, this pilot study supports the need for a larger randomized control trial to further evaluate VIT's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. Leyton, F., Olhaberry, M., Morán, J., et al.[2021]

The newly adapted Lighthouse-Parenting Program aims to enhance the mentalizing abilities of parents with mental illnesses, which is crucial for improving their caregiving skills and the parent-child relationship.

Initial pilot testing suggests that the program is a promising and easily implementable approach within existing mental health care systems, with plans for a randomized controlled trial to further evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Strengthening Attachment Competencies in Parents with Mental Illness: Adaptation and Pilot Testing of the Mentalization-Based Lighthouse Parenting Program]. Volkert, J., Georg, A., Hauschild, S., et al.[2019]

The study involved 682 parents and 487 youth, examining the effectiveness of the Connect program, an attachment-based intervention, over 18 months, revealing three distinct response patterns among youth with behavioral and mental health issues.

Youth with severe externalizing problems showed the most significant improvement, while those with both externalizing and internalizing issues had moderate responses, indicating the need for personalized interventions based on individual characteristics like attachment anxiety and caregiver strain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and Predictors of Different Youth Responses to Attachment-Based Parent Intervention. Pasalich, DS., Craig, SG., Goulter, N., et al.[2022]

The ATTACHTM program, which focuses on enhancing parental reflective function, has shown promise in improving parenting quality and child development outcomes in previous pilot studies with 64 participants.

The current study will evaluate the effectiveness of ATTACHTM in real-world settings with 100 families, assessing various outcomes including parent-child interactions and immune function, while also exploring the feasibility of its implementation through qualitative interviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for Attachment & Child Health (ATTACHTM) program: promoting vulnerable Children's health at scale. Anis, L., Letourneau, N., Ross, KM., et al.[2022]

The brief, online mindful parenting program called Two Hearts was found to be feasible and acceptable for parents, with all six participants completing the 4-week program and reporting lasting benefits.

Three out of six parents showed a reliable reduction in parenting stress after the program, with two achieving clinically significant improvements, indicating potential effectiveness for some parents, though adherence and dosage need further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief online mindful parenting program: Feasibility and initial effects pilot in a community sample. Sherwood, A., Paynter, J., Emerson, LM.[2023]

The VIPP intervention significantly improved maternal sensitivity in a sample of 54 low-sensitive Lithuanian mothers, with a large effect size (d = 0.78), indicating its efficacy in enhancing positive parenting skills.

Despite improvements in maternal sensitivity, the intervention did not lead to increased attachment security in infants, suggesting that while mothers can become more responsive, this does not automatically translate to stronger attachment bonds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting insensitive mothers: the Vilnius randomized control trial of video-feedback intervention to promote maternal sensitivity and infant attachment security. Kalinauskiene, L., Cekuoliene, D., Van Ijzendoorn, MH., et al.[2009]

The study evaluates the effectiveness of the Circle of Security-Parenting (COS-P) program in improving maternal sensitivity and child attachment among 314 families with infants aged 2-12 months, compared to standard care.

By screening a larger population of 17,600 families for risks like maternal postnatal depression, the study aims to address early childhood adversity and promote better long-term developmental outcomes for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Copenhagen infant mental health project: study protocol for a randomized controlled trial comparing circle of security -parenting and care as usual as interventions targeting infant mental health risks. Væver, MS., Smith-Nielsen, J., Lange, T.[2019]

The ATTACHTM program, a parenting intervention for high-risk families, significantly improved secure attachment between caregivers and their children, as well as enhanced parental reflective function, based on data from 40 participants in pilot studies.

Caregivers who participated in the ATTACHTM program showed a protective effect against depression, indicating that the program not only supports parenting skills but also contributes to the mental well-being of parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Attachment and Child Health (ATTACHTM) Parenting Program on Parent-Infant Attachment, Parental Reflective Function, and Parental Depression. Anis, L., Ross, K., Ntanda, H., et al.[2023]

The Virtual-VIPP program, an online adaptation of a parenting intervention, has been shown to be feasible and well-received by families, demonstrating similar effectiveness to traditional face-to-face methods.

A systematic review of 17 trials indicates that online parenting interventions can reach a broader audience and offer better cost-effectiveness, but further rigorous testing of their efficacy is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the virtual-VIPP and a systematic review of online support for families during the COVID-19 pandemic. van Ijzendoorn, MH., Stevens, E., Bakermans-Kranenburg, MJ.[2023]

The online adaptation of the Connect parenting intervention (eConnect) significantly improved youth mental health and family functioning in a clinical sample of 190 parents, showing reductions in youth behavioral problems and caregiver strain.

Despite high satisfaction and completion rates (84.7%), the program did not lead to a decrease in parent depressed mood, possibly due to external stressors like the pandemic, indicating a need for further research and adaptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eConnect: implementation and preliminary evaluation of a virtually delivered attachment-based parenting intervention during COVID-19. Bao, L., Moretti, MM.[2023]

Technology-based parenting interventions are effective in improving the emotional wellbeing of both parents and children, showing moderate effect sizes compared to control groups based on a meta-analysis of 22 studies.

These interventions also lead to higher attendance and participation rates compared to traditional parenting programs, suggesting that technology can enhance engagement in parenting support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-based parenting interventions for children's physical and psychological health: a systematic review and meta-analysis. Flujas-Contreras, JM., García-Palacios, A., Gómez, I.[2020]

The 'Cool Little Kids Online' program aims to prevent anxiety disorders in young children with inhibited temperament, and it will be evaluated in a large randomized controlled trial involving 385 parents of children aged 3-6 years.

The study will assess the program's efficacy by measuring changes in parent-reported child anxiety symptoms and other related outcomes over a 24-week period, potentially providing an accessible resource for families at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing anxiety problems in children with Cool Little Kids Online: study protocol for a randomised controlled trial. Morgan, AJ., Rapee, RM., Tamir, E., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Video-feedback intervention with maltreating parents and their children: program implementation and case study. [2014]

2. Austria pubmed.ncbi.nlm.nih.gov

Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Strengthening Attachment Competencies in Parents with Mental Illness: Adaptation and Pilot Testing of the Mentalization-Based Lighthouse Parenting Program]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Patterns and Predictors of Different Youth Responses to Attachment-Based Parent Intervention. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Study protocol for Attachment & Child Health (ATTACHTM) program: promoting vulnerable Children's health at scale. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A brief online mindful parenting program: Feasibility and initial effects pilot in a community sample. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Supporting insensitive mothers: the Vilnius randomized control trial of video-feedback intervention to promote maternal sensitivity and infant attachment security. [2009]

9. England pubmed.ncbi.nlm.nih.gov

Copenhagen infant mental health project: study protocol for a randomized controlled trial comparing circle of security -parenting and care as usual as interventions targeting infant mental health risks. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Attachment and Child Health (ATTACHTM) Parenting Program on Parent-Infant Attachment, Parental Reflective Function, and Parental Depression. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Development of the virtual-VIPP and a systematic review of online support for families during the COVID-19 pandemic. [2023]

12. England pubmed.ncbi.nlm.nih.gov

eConnect: implementation and preliminary evaluation of a virtually delivered attachment-based parenting intervention during COVID-19. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Technology-based parenting interventions for children's physical and psychological health: a systematic review and meta-analysis. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Preventing anxiety problems in children with Cool Little Kids Online: study protocol for a randomised controlled trial. [2019]