Home/Loved One/NCT04857775
NARECRUITING
View on ClinicalTrials.gov

Testing Attachment and Child Health (ATTACH) for depression

Official title: Adaptation and Pilot Testing of Web and Mobile Interface for the ATTACH™ Intervention

Attachment and Child Health (ATTACH™)

Condition: DepressionSponsor: University of CalgaryTarget enrollment: 100

Interventions

BEHAVIORAL

Attachment and Child Health (ATTACH) Parenting Program

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.

Canadian Sites (1)

University of Calgary

Calgary, Alberta, Canada

RECRUITING

Eligibility Criteria

See who this study is looking for4 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +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 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 the dried blood sample collection from themselves and their children (in Calgary agencies)
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

What is being given or done in this study: Attachment and Child Health (ATTACH) Parenting Program.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
  • armsInterventionsModule.interventions[].name
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

There is one group in this study.

From the trial registry

Built from this field:

  • armsInterventionsModule.armGroups[].type
Who the study is looking for

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 100 people.

The study is currently expected to finish around December 2027.

The main measurement is taken over: Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → PCITS scores after completion of intervention (an average of 10 weeks).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Mother Child interaction Quality will be assessed by Parent Child Interaction Teaching Scale (PCITS) — measured over Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → PCITS scores after completion of intervention (an average of 10 weeks).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT04857775 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About 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.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → PCITS scores after completion of intervention (an average of 10 weeks)..

The study as a whole is currently expected to finish around 2027-12-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 100 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Calgary, Alberta, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About 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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.