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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program aimed at helping parents improve their relationship with young children, especially in challenging situations like family violence or depression. The goal is to determine if this program can enhance children's mental health and development and facilitate its use in real-world settings. Parents with children under 3 years old who are willing to participate in weekly online training sessions for ten weeks may be suitable candidates. As an unphased trial, this study provides a unique opportunity for parents to contribute to research that could enhance family well-being and child development.

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 prior data suggests that the ATTACH™ Online platform is safe for strengthening parent-child relationships?

Research shows that the ATTACH™ Online platform is safe for participants. Previous studies on the ATTACH™ program have demonstrated positive effects on parents and children without any serious side effects. In one study with 90 families, the program greatly improved the parent-child relationship and the children's mental health. Another study with 10 families tested the online version and found it effective and easy to use. These results suggest that the online platform is safe for families facing early childhood challenges. No major unwanted health effects have been reported, making it a promising option for families seeking support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ATTACH™ Online Parenting Program because it offers a unique approach to strengthening parent-child relationships without the need for traditional face-to-face therapy sessions. Unlike standard parenting interventions that often rely on in-person workshops or therapy, ATTACH™ is delivered entirely online, making it more accessible and convenient for families. Additionally, the program's quasi-experimental design reflects real-world service delivery, addressing ethical concerns by moving away from control groups that might delay access to potentially beneficial interventions. This approach could lead to more inclusive and rapid improvements in parenting practices and child outcomes.

What evidence suggests that the ATTACH™ Online platform is effective for strengthening parent-child relationships?

Research has shown that the ATTACH™ Online platform, which participants in this trial will use, greatly improves the quality of the relationship between parents and children. In studies with 90 families, the program helped parents better understand their own and their child's thoughts and feelings. This improvement led to better mental health and development for the children. The program also positively affected children's thinking and movement skills. These findings suggest that the ATTACH™ Online platform effectively supports families dealing with early challenges. ^{1 2 3 6 7}

Who Is on the Research Team?

Nicole Letourneau, PhD RN

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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 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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04853888

ATTACH™ Program: Promoting Vulnerable Children's ... ATTACH™ significantly improved: (a) parent-child relationship quality and attachment, (b) parents' RF scores, and (c) children's cognitive and motor development ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40205561/

helping children vulnerable to early adversity The two objectives of this study are to evaluate: (1) effectiveness, and (2) implementation fidelity and uptake of ATTACH™ Online in community ...

3. trial.medpath.com trial.medpath.com/clinical-trial/07e3824bd462e7bb/nct05994027-attachment-child-health-online-platform

ATTACH™ Online Platform: Helping Children Vulnerable to ... In research with 90 families, investigators found the intervention significantly improved RF, parent-child relationship quality, and children's ...

4. mdpi.com mdpi.com/1660-4601/20/4/3078

Impacts of the Attachment and Child Health (ATTACHTM) ... ATTACH™ positively impacts parental RF to prevent negative impacts on children at risk of maltreatment. Keywords: ATTACH; parental reflective function; ...

5. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-022-03439-3

Study protocol for Attachment & Child Health (ATTACHTM ... The purpose of the study is to conduct an effectiveness-implementation hybrid (EIH) Type II study of ATTACH TM to assess its impacts in naturalistic, real- ...

6. withpower.com withpower.com/trial/phase-relation-parent-child-9-2022-0c8b8

ATTACH™ Parenting Program for Strengthening ... The ATTACH™ medical study, being run by University of Calgary, is evaluating whether ATTACH™ Online platform will have tolerable side effects & efficacy for ...

7. mdpi.com mdpi.com/1660-4601/19/14/8425

Effect of Attachment and Child Health (ATTACHTM) ... Compared with the control group, caregivers who received the ATTACHTM-program demonstrated a greater likelihood of secure attachment with their children (p = ...