ATTACH™ Parenting Program for Strengthening Parent-Child Relationships

(ATTACH™ Trial)

Overseen By Martha Hart, PhD

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)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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™ Online platform treatment for strengthening parent-child relationships?

Research on similar online parenting programs, like eConnect, shows that virtual attachment-based interventions can improve family functioning and reduce youth behavior problems. Additionally, studies on internet-based parent training suggest that such programs are feasible and well-received by parents, indicating potential for positive outcomes with the ATTACH™ Online platform. ^{1 2 3 4 5}

Is the ATTACH™ Parenting Program safe for participants?

The available research does not provide specific safety data for the ATTACH™ Parenting Program or its related platforms. However, similar attachment-based programs like eConnect have shown high program satisfaction and completion rates, suggesting they are generally well-received by participants. ^{2 4 6 7 8}

How is the ATTACH™ Online platform treatment different from other treatments for strengthening parent-child relationships?

The ATTACH™ Online platform is unique because it focuses on improving parental reflective function, which is the ability of parents to understand their own and their child's thoughts and feelings. This approach helps buffer the effects of toxic stress and promotes healthier outcomes for children, unlike traditional behavioral parenting programs that may not address the emotional quality of the parent-child relationship. ^{4 9 10 11 12}

Research Team

Nicole Letourneau, PhD RN

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for parents with children from birth to 32 months old, who are willing to participate in a 10-week online parenting program. The program includes one-hour weekly training sessions and encourages bringing a co-parent for two of the sessions if possible.

Inclusion Criteria

I am a parent of a child who is between birth and 32 months old.

I agree to join a 10-week online parent training program.

I agree to bring a co-parent to 2 of the 10 sessions, if possible.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the ATTACH™ Online platform intervention to improve parent-child relationship quality and children's mental health and development

Varies

Delivered virtually

Immediate Post-Intervention Assessment

Assessment of children's mental health and development, parent-child relationship quality, and parental reflective function immediately after intervention

1 week

Follow-up

Participants are monitored for changes in outcomes such as children's mental health and development, and parent-child relationship quality at 3 months post-intervention

3 months

Treatment Details

Interventions

• ATTACH™ Online platform

Trial Overview The ATTACH™ Online Platform Parenting Program is being tested. It's designed to improve parent-child relationships and child development by enhancing parents' understanding of their own and their child's thoughts and feelings, especially after early adversity like family violence or parental depression.

Participant Groups

Group I: ATTACH™ Online Platform Parenting Program 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, healthcare professionals, and health system administrators in engagement activities surrounding the preparation of this proposal.

ATTACH™ Online platform is already approved in Canada for the following indications:

Approved in Canada as ATTACH Online Platform for:

• Early childhood adversity intervention
• Parent-child relationship improvement
• Children's mental health and development support

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

A clinician-supported, web-based early intervention for preterm infants showed some positive effects on the parent-child relationship and maternal mental health, particularly reducing the odds of maternal depression at 12 months.

However, at 24 months, the intervention did not significantly improve child development outcomes compared to standard care, indicating that while it may benefit parental well-being, its impact on child cognitive and emotional development may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preterm Infant Outcomes at 24 Months After Clinician-Supported Web-Based Intervention. Treyvaud, K., Eeles, AL., Spittle, AJ., et al.[2022]

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]

A study involving 160 low-income parents showed that most had good access to the internet and were comfortable using it, indicating a strong potential for internet-based parent training programs.

In a pilot study with 89 parents, while there was high initial interest in an online parenting program, only 9% reported frequent use, highlighting the need for strategies to encourage deeper engagement with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Internet-based Parent Training for Low-income Parents of Young Children. McGoron, L., Hvizdos, E., Bocknek, EL., et al.[2019]

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 personalized remote video feedback parenting program significantly improved mother-child interactions among mothers of children with behavior problems, particularly enhancing the teaching dimension of their interactions.

Post-intervention assessments indicated that more children from the behavior problems group were classified as having normal behavior, suggesting positive outcomes in child behavior as a result of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strengthening mother-child interactions among mothers and children with behavior problems at early development. de Oliveira, RC., Altafim, ERP., Gaspardo, CM., et al.[2023]

The SAFE® program significantly improved secure attachment between infants and their fathers, with 84.6% of infants in the SAFE group securely attached compared to 65.8% in the control group, based on a year-long randomized control trial.

While the program effectively enhanced father-infant attachment, it did not show a significant difference in secure attachment between mothers and infants, indicating a targeted impact on father involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

*The efficacy of the attachment-based SAFE® prevention program: a randomized control trial including mothers and fathers. Walter, I., Landers, S., Quehenberger, J., et al.[2020]

Digital health interventions, such as mobile apps and electronic health records, can enhance patient safety for children and their parents by providing preventive measures and risk management strategies, as identified in a scoping review of 13 studies.

These interventions can improve the continuity of care from hospitalization to home, thereby increasing children's safety and quality of care through better engagement with healthcare providers after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health intervention on patient safety for children and parents: A scoping review. Park, J., Jeon, H., Choi, EK.[2023]

Video feedback interventions significantly improve parental sensitivity in parents of children at risk for poor attachment, with moderate-certainty evidence from 20 studies involving 1757 parent-child dyads.

There is very low-certainty evidence that video feedback may increase the likelihood of secure attachment in children, but results vary based on measurement methods, and no significant effects were found on parental stress or anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video feedback for parental sensitivity and attachment security in children under five years. O'Hara, L., Smith, ER., Barlow, J., et al.[2023]

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 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]

Drug-dependent mothers often struggle with parenting, which can negatively affect their children's development from infancy through adolescence.

This paper proposes attachment-based parenting interventions as a potentially more effective approach than traditional behavioral programs, emphasizing the emotional quality of mother-child relationships, and presents preliminary data supporting the feasibility of such interventions in outpatient drug treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rethinking parenting interventions for drug-dependent mothers: from behavior management to fostering emotional bonds. Suchman, N., Mayes, L., Conti, J., et al.[2019]

In a 5-month study involving 319 parents, the text messaging program (MyTeen) successfully recruited 221 participants, surpassing the target of 214, indicating effective recruitment strategies.

Web-based recruitment methods were particularly effective, but challenges remained in engaging ethnic minority groups and fathers, highlighting the need for targeted outreach in future parenting program trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment and Retention of Parents of Adolescents in a Text Messaging Trial (MyTeen): Secondary Analysis From a Randomized Controlled Trial. Chu, JTW., Wadham, A., Jiang, Y., et al.[2022]

References

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

Preterm Infant Outcomes at 24 Months After Clinician-Supported Web-Based Intervention. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

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

Feasibility of Internet-based Parent Training for Low-income Parents of Young Children. [2019]

4. 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]

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

Strengthening mother-child interactions among mothers and children with behavior problems at early development. [2023]

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

*The efficacy of the attachment-based SAFE® prevention program: a randomized control trial including mothers and fathers. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Digital health intervention on patient safety for children and parents: A scoping review. [2023]

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

Video feedback for parental sensitivity and attachment security in children under five years. [2023]

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

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

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

Rethinking parenting interventions for drug-dependent mothers: from behavior management to fostering emotional bonds. [2019]

12. Canada pubmed.ncbi.nlm.nih.gov

Recruitment and Retention of Parents of Adolescents in a Text Messaging Trial (MyTeen): Secondary Analysis From a Randomized Controlled Trial. [2022]