ATTACH™ Virtual Parenting Program for Children's Mental Health
(ATTACH™ Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Calgary
No Placebo Group
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.
12345Is 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.
678910How 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.
611121314Eligibility 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)
+1 more
Exclusion Criteria
None
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Intervention groupExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of CalgaryCalgary, Canada
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Who Is Running the Clinical Trial?
University of CalgaryLead Sponsor
References
Video-feedback intervention with maltreating parents and their children: program implementation and case study. [2014]This article describes a video-feedback intervention program with maltreating parents and their children aged 1 to 5 years using a case-study approach. The 8-week program is of interest to researchers and clinicians because it is the first short-term attachment-based intervention program to demonstrate efficacy in enhancing parental sensitivity, improving child attachment security, and reducing disorganized attachment for children and parents who have been reported for child abuse and/or neglect. We have previously described the theoretical and empirical basis of the intervention program and evidence for its efficacy. Details of program implementation and a case study are currently presented.
Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers. [2019]Maternal psychopathology and traumatic life experiences may adversely impact family functioning, the quality of the parent-child relationship and the attachment bond, placing the child's early social-emotional development at risk. Attachment-based parenting interventions may be particularly useful in decreasing negative outcomes for children exposed to risk contexts, yet high risk families frequently do not engage in programs to address mental health and/or parenting needs. This study evaluated the effects of Mom Power (MP), a 13-session parenting and self-care skills group program for high-risk mothers and their young children (age
Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. [2021]During child psychiatry hospitalization, working with the families or attachment figures is a challenge, most of the children who are admitted to these units come from multi-problem families, with limited research in this area. Video feedback (VF) interventions have proved to be a powerful resource to promote parental and child well-being in small children and has been used with parents with a psychiatric condition. Parental Reflective Functioning (PRF) is one of the parental abilities that can be improved with VF and could be especially important in coping with conflict and negative emotions in older children. The aim of this study is to implement Video Intervention Therapy (VIT) to enhance PRF in primary caregivers of inpatient psychiatric children. As there is no published research using VF with parents of children with severe psychopathology in a hospitalized context. This report, then, becomes a much needed pilot study providing evidence for a larger randomized control trial (RCT).
[Strengthening Attachment Competencies in Parents with Mental Illness: Adaptation and Pilot Testing of the Mentalization-Based Lighthouse Parenting Program]. [2019]Strengthening Attachment Competencies in Parents with Mental Illness: Adaptation and Pilot Testing of the Mentalization-Based Lighthouse Parenting Program Mentalizing describes the imaginative ability to understand human behaviour in terms of mental states. Parents with mental illnesses and experiences of early maltreatment frequently show impairments in mentalizing, which negatively impact their caregiving competences for the child. A number of mentalization-based programs to strengthen parental competences have been developed and most of them have been positively evaluated with regard to their efficacy. However, approaches which specifically aim to reach highly impaired families with children from different age groups and which can be implemented in psychiatric settings are currently lacking. The newly adapted mentalization-based Lighthouse-Parenting Program aims to fill this gap and strengthen competences of parents with a mental illness. The specific MBT-based stance, the structure and content of this new program are outlined and first results of a pilot test are presented. The program is a promising approach, which can easily be trained and implemented in existing mental health care systems. The Lighthouse-Parenting Program aims to improve the relationship between parent and child, to reduce parental stress and in the long-term to promote the child's development. A randomized controlled trial to evaluate the program's effectiveness is currently being planned.
Patterns and Predictors of Different Youth Responses to Attachment-Based Parent Intervention. [2022]Label="OBJECTIVE">Few studies have evaluated attachment-based parent interventions for pre-teens and teens, and in particular, differential adolescent trajectories of response. This study examined distinct patterns, and multi-level predictors, of intervention response among youth with serious behavioral and mental health problems whose parents participated in Connect, an attachment- and trauma-informed parent program.
Study protocol for Attachment & Child Health (ATTACHTM) program: promoting vulnerable Children's health at scale. [2022]Label="BACKGROUND">Children's exposure to toxic stress (e.g., parental depression, violence, poverty) predicts developmental and physical health problems resulting in health care system burden. Supporting parents to develop parenting skills can buffer the effects of toxic stress, leading to healthier outcomes for those children. Parenting interventions that focus on promoting parental reflective function (RF), i.e., parents' capacity for insight into their child's and their own thoughts, feelings, and mental states, may understand help reduce societal health inequities stemming from childhood stress exposures. The Attachment and Child Health (ATTACHTM) program has been implemented and tested in seven rapid-cycling pilot studies (n = 64) and found to significantly improve parents' RF in the domains of attachment, parenting quality, immune function, and children's cognitive and motor development. The purpose of the study is to conduct an effectiveness-implementation hybrid (EIH) Type II study of ATTACHTM to assess its impacts in naturalistic, real-world settings delivered by community agencies rather than researchers under more controlled conditions.
A brief online mindful parenting program: Feasibility and initial effects pilot in a community sample. [2023]Mindful parenting programs are effective in reducing parenting stress. More efficient offerings may increase accessibility. The current single case study aimed to determine the feasibility, acceptability and initial effects of a brief, online mindful parenting program. Six parents, recruited from the community, completed a 4-week online mindful parenting program (Two Hearts). Feasibility and acceptability were assessed by participant program evaluation, retention, engagement with program materials (i.e., videos), and home practice. Parents completed primary outcome measurements of parenting stress, and general distress, at pre- and post-intervention, and 4-week follow-up. Individual level reliable change index and clinically significant change were calculated for outcome measures. All parents were retained through the study; all participants reported obtaining something of lasting value from the training. Program adherence varied over time. At post-intervention, four parents reported 40-50 minutes practice per week; two parents reported 10-15 minutes practice per week. At follow-up, 50% of parents reported 30-50 minutes practice per week. Three parents showed a reliable reduction in parenting stress; two of these parents demonstrated clinically significant change. Improvements in parent general distress were indicated in half the sample. Two parents experienced a clinically significant increase in parenting stress and/or general distress. In conclusion, the Two Hearts program demonstrated good acceptability, and may be a feasible and effective program for some parents. Program adherence and dosage require further investigation. The role of acute stressors (e.g., COVID-19) must be also considered.
Supporting insensitive mothers: the Vilnius randomized control trial of video-feedback intervention to promote maternal sensitivity and infant attachment security. [2009]This randomized control trial examined the effects of a short-term, interaction-focused and attachment-based video-feedback intervention (VIPP: video-feedback intervention to promote positive parenting). Design VIPP effect on mothers' sensitive responsiveness and infant-mother attachment security was evaluated in a sample (n = 54) of low sensitive, non-clinical, middle class Lithuanian mothers.
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]Infant mental health is a significant public health issue as early adversity and exposure to early childhood stress are significant risk factors that may have detrimental long-term developmental consequences for the affected children. Negative outcomes are seen on a range of areas such as physical and mental health, educational and labor market success, social network and establishing of family. Secure attachment is associated with optimal outcomes in all developmental domains in childhood, and both insecure and disorganized attachment are associated with a range of later problems and psychopathologies. In disadvantaged populations insecure and disorganized attachment are common, which points to the need of identifying early risk and effective methods of addressing such problems. This protocol describes an experimental evaluation of an indicated group-based parental educational program, Circle of Security-Parenting (COS-P), currently being conducted in Denmark.
Effect of Attachment and Child Health (ATTACHTM) Parenting Program on Parent-Infant Attachment, Parental Reflective Function, and Parental Depression. [2023]High-risk families exposed to toxic stressors such as family violence, depression, addiction, and poverty, have shown greater difficulty in parenting young children. In this study, we examined the effectiveness of ATTACHTM, a 10−12 session manualized one-on-one parental Reflective Function (RF)-based parenting program designed for high-risk families. Outcomes of parent-child attachment and parental RF were assessed via the Strange Situation Procedure (SSP) and Reflective Function Scale (RFS), respectively. The protective role of ATTACHTM on parental depression was also assessed. Data were available from caregivers and their children
Development of the virtual-VIPP and a systematic review of online support for families during the COVID-19 pandemic. [2023]During the COVID-19 pandemic lockdowns made it impossible for parenting coaches to reach the families without digital means of communication. Several studies were initiated to transform existing parenting interventions into hybrid or fully online versions and to examine their feasibility, acceptability and efficacy. We present one such transformation in detail, the Virtual-VIPP which is based on Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD). Furthermore, we report a systematic review of 17 published trials with online versions of parenting programs. Overall, online parenting interventions seem feasible to implement, are well-received by most families, and to show equivalent effects to face-to-face approaches. Careful preparation of technicalities and monitoring of fidelity are prerequisites. Advantages of online parenting interventions are their potentially broader reach, more detailed process documentation, and better cost-utility balance. We expect that online parenting interventions are here to stay, but their efficacy needs to be rigorously tested.
eConnect: implementation and preliminary evaluation of a virtually delivered attachment-based parenting intervention during COVID-19. [2023]Connect, an attachment-based and trauma-informed parenting group intervention, has been demonstrated to improve adolescent mental health, parental wellbeing, and family functioning. We report on the online adaptation and delivery of Connect (eConnect) and pre-post treatment changes in parent, family and youth functioning in a clinical sample (N= 190) of parents of youth with serious mental health challenges. Consistent with research evaluating in-person Connect, parents reported significant reductions in youth internalizing and externalizing problems, attachment anxiety and avoidance, and aggression toward parents. Parents also reported significant reductions in caregiver strain and aggression toward their child. Unlike prior research, parent depressed mood did not decline, perhaps due to pandemic stressors. Program completion was remarkably high (84.7%), and parents reported high program satisfaction. Uptake by eConnect program facilitators and host agencies was extremely positive, suggesting good potential for sustainability and broadened program accessibility. Randomized clinical trials and implementation within diverse populations are needed.
Technology-based parenting interventions for children's physical and psychological health: a systematic review and meta-analysis. [2020]Parenting interventions have important consequences for the wellbeing and emotional competences of parents and their children. Technology provides an opportunity with advantages for psychological intervention. The aim of this systematic review and meta-analysis is to analyze the characteristics and effectiveness of technology-based interventions for parents to promote children's physical health or psychological issues.
Preventing anxiety problems in children with Cool Little Kids Online: study protocol for a randomised controlled trial. [2019]Anxiety disorders are the most common type of mental health problem and begin early in life. Early intervention to prevent anxiety problems in young children who are at risk has the potential for long-term impact. The 'Cool Little Kids' parenting group program was previously established to prevent anxiety disorders in young children at risk because of inhibited temperament. This group program was efficacious in two randomised controlled trials and has recently been adapted into an online format. 'Cool Little Kids Online' was developed to widen and facilitate access to the group program's preventive content. A pilot evaluation of the online program demonstrated its perceived utility and acceptability among parents. This study aims to evaluate the efficacy of Cool Little Kids Online in a large randomised controlled trial.