DepressionATTACH™NCT04857775
Adaptation and Pilot Testing of Web and Mobile Interface for the ATTACH™ Intervention
A study testing Attachment and Child Health (ATTACH) Parenting Program in people with Depression and Addiction, run by University of Calgary at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depression, Addiction, Domestic Violence
- What is being tested?
- Attachment and Child Health (ATTACH) Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
- parents agree to the dried blood sample collection from themselves and their children (in Calgary agencies)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Nicole Letourneau, RN, PhD, 403-210-3833, nicole.letourneau@ucalgary.ca
About this study
Official title: Attachment and Child Health (ATTACH™)
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.
Read the detailed description
ATTACH™ is well established and positioned for transition to an online format as the clinic visit program has: 1) been tested and found to be effective in seven rapid-cycling RCT's; 2) been named a Frontiers of Innovation Project of the Harvard Center of the Developing Child; 3) attained a CIHR Innovative Clinical Trial (ICT) grant to scale and spread the program across Canada; 4) three agencies already independently delivering the clinic program (Discovery House, CUPS and Alcove Addictions Recovery); and 5) agency health-service providers and families have requested an online ATTACH™ program. As building on this sound foundation requires less validation than a newly formed program, ATTACH™ online is poised for rapid uptake by the community partners, and tremendous impact.
Methods: Using participatory design and iKT approaches, the multidisciplinary team (Nursing and Software Engineering) will work collaboratively with mothers enrolled in the ongoing ATTACH™ pilot studies along with health-service providers and professional facilitators, to co-design the user interfaces for virtual delivery of ATTACH™. The goal is to develop and test a functioning minimum viable product (MVP) that is robust and reliable. We propose to undertake a four-phase study as follows:
Phases 1 and 2: Exploratory - user engagement to identify content and explore design challenges and user preferences, followed by prototyping of interface designs; Phase 3: Software Development - iterative design sessions with users to develop MVPs; and Phase 4: Pilot Test - beta test MVPs and refine user interface designs.
System Design (Phases 1-4) In Phase 1, content and delivery protocols for ATTACH™ will be determined with each program's Health-Service Provider Advisory Committee (H-SPAC), comprised of service providers who deliver the program. Further, 6 parents recruited from the ongoing or past intervention program studies and 6 H-SPAC members will take part in separate recorded Zoom focus group sessions and a REDcap survey (open and close-ended questions) to explore their experiences with online delivery of the parenting intervention and user-interface design preferences. Data will be transcribed verbatim and reviewed by design team for key design elements to be incorporated into interface prototypes (e.g., mobile app, web-based application) for co-design sessions. In Phase 2, a series of weekly design sessions (3-4) will be conducted with 6 Phase 1 parents and 6 H-SPAC members who will co-design prototypes of user interfaces for virtual intervention programs. Design sessions will be conducted via Zoom, using a whiteboard application to facilitate the co-design process, and recorded for later analysis by the design team. In Phase 3, an agile iterative software design approach will be used to integrate user feedback into design prototypes for 3-4 weekly design sessions, resulting in MVPs for ATTACH™. In Phase 4, two unique MVPs will be pilot (beta) tested with parents and a brief REDcap survey will assess user satisfaction. Refinements will be made to the final MVPs based on user feedback, resulting in the final web-interface.
Pilot Testing to Examine Child Mental, Emotional and Behavioural (MEB) Health and Development Outcomes (Phase 4). Parents will be recruited from Discovery House and CUPS for ATTACH™ (n=20; fewer as more sessions). Quasi-experimental design methods (pre/post-test) will evaluate the impact of the MVPs, for both programs, on the primary outcome of children's MEB health and development (Ages and Stages-3rd Ed. and Socio-emotional 2nd d.). Secondary outcomes include parent-infant interaction quality (via the Parent-Child Interaction Teaching Scale) and RF (in ATTACH™). As this new research program is built upon existing CIHR grant designed to test the clinic visit programs, we will determine both within group changes from the virtual program versions and compare virtual to clinic visit versions, once studies resume. Outcomes will be assessed with parametric (e.g. paired and independent t-tests), non-parametric equivalent tests, and effect size statistics as appropriate.
- Conditions
- Depression, Addiction, Domestic Violence, Poverty
- Being tested
- Attachment and Child Health (ATTACH) Parenting Program
- Medical subject headings
- Depression, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment and Child Health (ATTACH) Parenting ProgramBehavioural
ATTACH™ provides parent training to address Reflective Function (RF) of parents affected by a broad array of toxic stressors. RF, defined as the ability to have insight into one's own and one's child's mental states, feelings, thoughts and intentions, underpins parental sensitivity and responsiveness and is undermined by the experience of current or past stress. Parents require high RF to respond sensitively/appropriately to their children and thus promote secure parent-child attachments, essential for child MEB health. ATTACH™ consists of 10-12 ~45-minute clinic visits with dyadic (mother and infant) and triadic (mother, infant, and co-parent) elements, with a trained facilitator, who may be a nurse, social worker or other allied health professional.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Attachment and Child Health (ATTACH) Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother Child interaction Quality will be assessed by Parent Child Interaction Teaching Scale (PCITS)
The Parent Child Interaction Teaching Scale will be used to evaluate Mother-child interactions. See Study Detailed Description and Intervention arm for more information on the PCITS Program. Scale range from 0 - 73. A higher score means a better outcome, i.e. higher quality of parent-child interaction.
Measured: Change from baseline PCITS scores after completion of intervention (an average of 10 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start15 Mar 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Letourneau, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857775
- Sponsor's protocol ID
- REB14-0368
- Acronym
- ATTACH™
- Status last verified
- May 2024
- First submitted
- 7 Apr 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attachment and Child Health (ATTACH™)
- ClinicalTrials.gov ID
- NCT04857775
- Acronym / sponsor ID
- ATTACH™ / REB14-0368
- Conditions
- Depression, Addiction, Domestic Violence, Poverty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ATTACH™ is well established and positioned for transition to an online format as the clinic visit program has: 1) been tested and found to be effective in seven rapid-cycling RCT's; 2) been named a Frontiers of Innovation Project of the Harvard Center of the Developing Child; 3) attained a CIHR Innovative Clinical Trial (ICT) grant to scale and spread the program across Canada; 4) three agencies already independently delivering the clinic program (Discovery House, CUPS and Alcove Addictions Recovery); and 5) agency health-service providers and families have requested an online ATTACH™ program. As building on this sound foundation requires less validation than a newly formed program, ATTACH™ online is poised for rapid uptake by the community partners, and tremendous impact.
Methods: Using participatory design and iKT approaches, the multidisciplinary team (Nursing and Software Engineering) will work collaboratively with mothers enrolled in the ongoing ATTACH™ pilot studies along with health-service providers and professional facilitators, to co-design the user interfaces for virtual delivery of ATTACH™. The goal is to develop and test a functioning minimum viable product (MVP) that is robust and reliable. We propose to undertake a four-phase study as follows:
Phases 1 and 2: Exploratory - user engagement to identify content and explore design challenges and user preferences, followed by prototyping of interface designs; Phase 3: Software Development - iterative design sessions with users to develop MVPs; and Phase 4: Pilot Test - beta test MVPs and refine user interface designs.
System Design (Phases 1-4) In Phase 1, content and delivery protocols for ATTACH™ will be determined with each program's Health-Service Provider Advisory Committee (H-SPAC), comprised of service providers who deliver the program. Further, 6 parents recruited from the ongoing or past intervention program studies and 6 H-SPAC members will take part in separate recorded Zoom focus group sessions and a REDcap survey (open and close-ended questions) to explore their experiences with online delivery of the parenting intervention and user-interface design preferences. Data will be transcribed verbatim and reviewed by design team for key design elements to be incorporated into interface prototypes (e.g., mobile app, web-based application) for co-design sessions. In Phase 2, a series of weekly design sessions (3-4) will be conducted with 6 Phase 1 parents and 6 H-SPAC members who will co-design prototypes of user interfaces for virtual intervention programs. Design sessions will be conducted via Zoom, using a whiteboard application to facilitate the co-design process, and recorded for later analysis by the design team. In Phase 3, an agile iterative software design approach will be used to integrate user feedback into design prototypes for 3-4 weekly design sessions, resulting in MVPs for ATTACH™. In Phase 4, two unique MVPs will be pilot (beta) tested with parents and a brief REDcap survey will assess user satisfaction. Refinements will be made to the final MVPs based on user feedback, resulting in the final web-interface.
Pilot Testing to Examine Child Mental, Emotional and Behavioural (MEB) Health and Development Outcomes (Phase 4). Parents will be recruited from Discovery House and CUPS for ATTACH™ (n=20; fewer as more sessions). Quasi-experimental design methods (pre/post-test) will evaluate the impact of the MVPs, for both programs, on the primary outcome of children's MEB health and development (Ages and Stages-3rd Ed. and Socio-emotional 2nd d.). Secondary outcomes include parent-infant interaction quality (via the Parent-Child Interaction Teaching Scale) and RF (in ATTACH™). As this new research program is built upon existing CIHR grant designed to test the clinic visit programs, we will determine both within group changes from the virtual program versions and compare virtual to clinic visit versions, once studies resume. Outcomes will be assessed with parametric (e.g. paired and independent t-tests), non-parametric equivalent tests, and effect size statistics as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Attachment and Child Health (ATTACH) Parenting ProgramA 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 may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
- parents agree to the dried blood sample collection from themselves and their children (in Calgary agencies)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attachment and Child Health (ATTACH) Parenting ProgramATTACH™ provides parent training to address Reflective Function (RF) of parents affected by a broad array of toxic stressors. RF, defined as the ability to have insight into one's own and one's child's mental states, feelings, thoughts and intentions, underpins parental sensitivity and responsiveness and is undermined by the experience of current or past stress. Parents require high RF to respond sensitively/appropriately to their children and thus promote secure parent-child attachments, essential for child MEB health. ATTACH™ consists of 10-12 ~45-minute clinic visits with dyadic (mother and infant) and triadic (mother, infant, and co-parent) elements, with a trained facilitator, who may be a nurse, social worker or other allied health professional. | Behavioural | Intervention group |
Primary outcome
Mother Child interaction Quality will be assessed by Parent Child Interaction Teaching Scale (PCITS)
Time frame: Change from baseline PCITS scores after completion of intervention (an average of 10 weeks).
The Parent Child Interaction Teaching Scale will be used to evaluate Mother-child interactions. See Study Detailed Description and Intervention arm for more information on the PCITS Program. Scale range from 0 - 73. A higher score means a better outcome, i.e. higher quality of parent-child interaction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment and Child Health (ATTACH) Parenting Program in people with Depression and Addiction, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother Child interaction Quality will be assessed by Parent Child Interaction Teaching Scale (PCITS) (time frame: Change from baseline PCITS scores after completion of intervention (an average of 10 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.