ATTACH™ Parenting Program for Parent-Child Relationship

(ATTACH™ Trial)

Overseen By Nicole Letourneau, PhD RN FAAN

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

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a parenting program can improve the relationship between parents and their young children, particularly those facing challenges like parental depression or domestic violence. The ATTACH™ Parenting Program helps parents understand their own and their children's thoughts and feelings, which is crucial for healthy child development. Researchers seek to evaluate the program's effectiveness when delivered by trained professionals in community settings and its impact on children's health markers related to stress. Eligible participants are parents with children up to 32 months old who can commit to weekly sessions and provide blood samples in Calgary. As an unphased trial, this study offers 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™ Parenting Program is safe for improving parent-child relationships?

Research has shown that the ATTACH™ Parenting Program is safe and well-tolerated. In studies involving 90 families, significant improvements were observed in parent-child relationships and children's mental health. These studies reported no negative effects related to the program, indicating that participants generally managed it well. Although the program has been tested in controlled settings, its safety in community settings with trained healthcare professionals continues to be monitored. However, based on past research, the program appears to be a safe choice for families seeking to enhance parent-child interactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ATTACH™ Parenting Program because it focuses on strengthening the parent-child relationship in a way that traditional methods may not. Unlike standard parenting interventions, which often focus on behavior management, ATTACH™ emphasizes building emotional connections and understanding between parents and children. This approach is seen as more ethical and effective for real-world application, as it avoids the need for control groups and aims to deliver immediate positive impacts on family dynamics. By enhancing these relationships, the program hopes to foster healthier emotional development in children, which could lead to long-term benefits.

What evidence suggests that the ATTACH™ Parenting Program is effective for improving parent-child relationships?

Research has shown that the ATTACH™ Parenting Program, which participants in this trial will receive, greatly improves the bond between parents and children. Studies have found that parents in the program become better at understanding their own and their child's thoughts and feelings. This skill links to positive effects on children's cognitive and motor skills. While early results are encouraging, it remains uncertain if these benefits persist when local community workers, rather than researchers, run the program. The program might also help reduce inflammation in children who have experienced high stress, but the exact effects on biological markers of inflammation are still under investigation. ^{2 3 6 7 8}

Who Is on the Research Team?

Nicole Letourneau, PhD RN FCAHS

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

The ATTACH™ Program is for parents with children from birth to 32 months who are dealing with toxic stress factors like depression, addictions, or poverty. Parents must commit to weekly training sessions for 10-12 weeks and agree to bring a co-parent when possible. They also need to consent to blood sample collection in certain locations.

Inclusion Criteria

parents agree to the dried blood sample collection from themselves and their children (in Calgary agencies)

I agree to join a 10-12 week parent training program for an hour each week.

I agree to bring a co-parent to 2-3 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™ psycho-educational parenting program to improve parent-child relationship quality and assess impacts on various health and development outcomes.

Varies by participant

Multiple sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in parent-child relationship quality, parental reflective function, and child development at 3 months post-intervention.

3 months

Implementation Evaluation

Evaluation of health care professionals' and administrators' perceptions and experiences of intervention uptake and fidelity, including qualitative interviews.

Ongoing until data saturation

What Are the Treatments Tested in This Trial?

Interventions

• ATTACH™ Parenting Program

Trial Overview This trial tests the ATTACH™ Parenting Program's effectiveness when delivered by healthcare professionals in community settings. It aims at improving parent-child relationships and child development outcomes by enhancing parents' understanding of thoughts and feelings (reflective function).

How Is the Trial Designed?

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+

Published Research Related to This Trial

Secure attachment relationships are crucial for children's development, and sensitive parenting is identified as a key factor in fostering these relationships.

The Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) is an effective program that enhances sensitive parenting, demonstrating its potential to support families in need of parenting assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective preventive interventions to support parents of young children: Illustrations from the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD). Juffer, F., Struis, E., Werner, C., et al.[2019]

In a pilot study involving 47 mothers in substance abuse treatment, those who participated in the Mothers and Toddlers Program (MTP) showed significantly improved parenting skills, including better reflective functioning and caregiving behavior compared to those in the Parent Education Program (PE).

The results suggest that attachment-based interventions like MTP may be more effective than traditional parenting programs in strengthening the relationships between mothers with substance use issues and their young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mothers and Toddlers Program, an attachment-based parenting intervention for substance using women: post-treatment results from a randomized clinical pilot. Suchman, NE., DeCoste, C., Castiglioni, N., et al.[2021]

The 'Connect' program, a ten-week intervention for parents of at-risk teens, significantly improved parenting satisfaction and reduced adolescents' aggression and antisocial behavior, with effects lasting up to 12 months after completion.

In a larger implementation involving 309 parents across 17 communities, the program led to notable reductions in both externalizing and internalizing problems in teens, as well as improvements in social functioning and affect regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an attachment-focused manualized intervention for parents of teens at risk for aggressive behaviour: The Connect Program. Moretti, MM., Obsuth, I.[2022]

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 study involved 73 parents and examined how both attachment styles and couple relationship quality influence children's adaptation as they transition to elementary school.

Results showed that a combined model of attachment theory and family risk factors significantly predicts children's academic achievement and behavioral outcomes, highlighting the importance of both parental attachment and couple dynamics in child development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult attachment, couple attachment, and children's adaptation to school: an integrated attachment template and family risk model. Cowan, PA., Cowan, CP., Mehta, N.[2009]

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 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 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]

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]

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]

Citations

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

ATTACH™ Program: Promoting Vulnerable Children's ... It focuses on improving parent-child relationship quality by targeting parents' reflective function (RF), i.e. the ability to better understand one's own and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35886276/

Effect of Attachment and Child Health (ATTACHTM) ... In this study, we examined the effectiveness of ATTACHTM, a 10−12 session manualized one-on-one parental Reflective Function (RF)-based ...

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

Impacts of the Attachment and Child Health (ATTACHTM) ... We hypothesize that families who receive the ATTACHTM intervention will demonstrate improved parental RF and child development outcomes, consistent with past ...

4. ncfr.org ncfr.org/ncfr-report/winter-2023/innovations-parent-edu-attachment-interventions-FMI

Innovations in Parent Education: Attachment Interventions ... In this article, we introduce empirically tested and research-based interventions for positive parent–child relationships along with a screening tool.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8501501/

The ATTACH™ program and immune cell gene expression ... Indeed, in randomized control trials, participating in the ATTACH™ program predicted improvements in parental reflective function, parent-child ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9324434/

Effect of Attachment and Child Health (ATTACHTM) Parenting ... We predicted that ATTACHTM would improve parent-child attachment security, parents' RF, and reduce parents' depression. We also predicted that improvement in ...

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

ATTACH™ Parenting Program for Strengthening ... In research with 90 families, investigators found the intervention significantly improved RF, parent-child relationship quality, and children's mental health ...

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

Study protocol for Attachment & Child Health (ATTACHTM ... ... ATTACHTM significantly improved parent-child relationship quality (d = .34–1.5) [9] parents' RF scores (d = .51–2.0) [10], and children's ...