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: 0

300 Participants Needed

Trial Summary

What is the purpose of this trial?

ATTACH™ is a psycho-educational parenting program, designed with community agencies serving families of preschoolers affected by toxic stress (e.g. parental depression, addictions, domestic violence, poverty) to bolster children's health and development. 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 one's child's thoughts and feelings. RF is essential for high quality parent-child relationships and secure attachment, both tied to child development and health, especially cognition, communication and inflammation. ATTACH™ was implemented and tested in seven rapid-cycling pilot studies by researchers, guided by the IDEAS (Innovate, Develop, Evaluate, Adapt, Scale) Framework™, an innovative clinical trial approach. ATTACH™ significantly improved: (a) parent-child relationship quality and attachment, (b) parents' RF scores, and (c) children's cognitive and motor development. However, whether ATTACH™ continues to work with delivery by trained agency healthcare professionals rather than study researchers, in naturalistic, community settings remains to be seen. Small sample sizes also limited the ability to assess longer-term impacts and whether ATTACH™ is equally effective across patient populations. Further, another parenting intervention successfully reduced systemic inflammation in children exposed to toxic stress. Whether ATTACH™ impacts novel biomarkers of inflammation (i.e. immune cell gene expression and DNA methylation) is not known.

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 Mothers and Toddlers Program and video-feedback interventions, shows they can improve parent-child relationships by enhancing parental sensitivity and child attachment security. These programs have been effective in various settings, including with parents facing challenges like substance use, suggesting that the ATTACH™ Parenting Program may also be beneficial. ^{1 2 3 4 5}

Is the ATTACH™ 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. ^{4 6 7 8 9}

How is the ATTACH™ Parenting Program treatment different from other treatments for improving parent-child relationships?

The ATTACH™ Parenting Program is unique because it focuses on enhancing the emotional quality of the parent-child relationship, which is crucial for children's psychological development. Unlike traditional behavioral parenting programs, it is attachment-based, aiming to foster emotional bonds rather than just managing behavior. ^{1 4 5 10 11}

Research Team

Nicole Letourneau, PhD RN FCAHS

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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).

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

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 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 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]

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]

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]

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 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 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 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 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 '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]

References

1. England 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. [2021]

2. 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]

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

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

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

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

5. United States 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). [2019]

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

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

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

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

8. 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]

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

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

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

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

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

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