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DepressionNCT04893850

Building Regulations in Dual Generations at KIDTHINK

A study testing BRIDGE Therapy Program and Community Services as Usual Clinical Referral list in people with Depression and Child Development, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Neurodevelopmental disorders (NDDs) such as attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), and intellectual disability (ID) are the most frequently diagnosed disability in children, accounting for 7% to 14% of children in developed countries. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Child Development, Self-regulation
What is being tested?
BRIDGE Therapy Program and Community Services as Usual Clinical Referral list
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteCanada
Study dates
14 Apr 2021to 11 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Parents/caregivers must have a 3-8 year old child.
  • The child must have diagnosed or emerging behavioural, emotional, or developmental concerns, as reported by parents.
  • Parents/caregivers must be experiencing elevated symptoms of psychological distress as measured by the Patient Health Questionnaire 9-item (PhQ-9).
  • Parents/caregivers must be 18 years of age.

Who cannot join

  • Child is outside of the 3-8 year old age range.
  • The child does not have diagnosed or emerging behavioural, emotional, or developmental concerns.
  • The parent or caregiver does not have full or joint custody of the child.
  • The parent or caregiver is not experiencing elevated symptoms of psychological distress as measured by the Patient Health Questionnaire 9-item (PhQ-9).
  • The parent or caregiver is not 18 years of age.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • The University of Manitoba - Department of Psychology

    Winnipeg, Manitoba, R3T 2N2

Other trials in Canada

About this study

Neurodevelopmental disorders (NDDs) such as attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), and intellectual disability (ID) are the most frequently diagnosed disability in children, accounting for 7% to 14% of children in developed countries. Developmental concerns emerge early, providing an opportunity to support families years before a diagnosis may occur. Emerging concerns are often predictive of problems with self-regulation, risky behaviours (e.g., substance abuse and over-eating), academic achievement, social functioning, parent-child relationship, and lower overall quality of life. Overall family wellbeing is also commonly affected given the increased challenges faced by parents and caregivers, including socioeconomic disadvantage. Parents facing hurdles to positive parenting, such as poor psychological wellbeing, may struggle further with parenting capacity in the context of the increased parenting demands of caring for a child with specific needs. The objective of this study is to create a novel adaptation of an existing program that is targeted at improving the mental wellness and parenting practices of caregivers (mothers, fathers, guardians) with elevated symptoms of depression who have 3 to 8-year-old children with emerging behavioural, emotional, or developmental concerns. It is hypothesized that taking a dual-generation intervention approach to addressing self-regulatory mechanisms underlying psychopathology at the level of the caregiver, child, and dyad (i.e. parenting interactions) will improve both caregiver capacities and child outcomes. Further, it is hypothesized that this novel adaptation of the program will be tailored to meet the identified needs of this demographic and that the program will show improvement in psychosocial, emotional, and parenting function compared to a services as usual control group. Our current study will be conducted remotely due to the COVID-19 pandemic to adhere to public health guidelines to reduce in-person contact and physical distance. The ultimate goal of this project is to improve parent wellbeing and promote supportive parenting practices that allow children with early developmental needs to reach their full potential.

Being tested
BRIDGE Therapy Program, Community Services as Usual Clinical Referral list
Medical subject headings
Depression, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BRIDGE Therapy ProgramBehavioural

    The BRIDGE Therapy Program is a novel manualized therapy that incorporates key parenting concepts and related Dialectical Behavior Therapy (DBT) modules. The primary aim of the program is to improve parent well-being and promote supportive parenting practices. There are two components of the program: 1) the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and target parental mental health symptomology, and 2) the parent skill training materials, which have been designed to correspond to the four core DBT modules (i.e., Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship.

  • Community Services as Usual Clinical Referral listBehavioural

    The community services as usual clinical referral list provides information on accessing psychological and family support services in Winnipeg. This resource is used to locate: crisis, distress, and support phone lines, counselling and peer-support resources, and free apps relating to mindfulness and meditation.

Study groups in NCT04893850
Study groupRoleWhat they receive
BRIDGE-KIDTHINK ConditionExperimentalCaregivers in this group will participate in 16 sessions of online therapy delivered through a combination of asynchronous material and virtual support groups. These sessions will include Dialectical Behaviour Therapy (DBT) and parenting training. This group will be asked to evaluate the program with surveys completed pre-program, immediately post-program, and three months post-program. This group will also be invited to complete weekly surveys expected to take 5 minutes.
Receives: Behavioral: BRIDGE Therapy Program
Services as Usual ConditionExperimentalCaregivers in this group will not participate in Dialectical Behaviour Therapy (DBT) and parenting training. Rather, this group will be asked to refer to a list of community mental health and family support services as part of the BRIDGE therapy program. This group will be asked to complete weekly surveys expected to take 5 minutes.
Receives: Behavioral: Community Services as Usual Clinical Referral list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the Child Behaviour Checklist (CBCL) from pre-intervention to post-intervention.

    99-item questionnaire used to measure child functioning across internalizing/externalizing problems. Participants respond to items on a 3-point Likert scale and are asked to describe their child's behavioural and emotional problems within the past 2 months.

    Measured: The Child Behaviour Checklist will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  2. Changes in the Life Events Checklist (LEC) from pre-intervention to post-intervention.

    34-item measure that assesses adverse life experiences of children.

    Measured: The Life Events Checklist will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  3. Changes in Child Functioning from pre-intervention to post-intervention.

    Open-ended questions regarding child functioning for qualitative analysis.

    Measured: Open-ended questions regarding child functioning will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

Secondary outcomes (12)
  1. Changes in parent/caregiver emotion regulation from pre-intervention to post-intervention - Difficulties in Emotion Regulation Scale (DERS-16).

    16-item measure that assesses emotional regulation, including awareness, clarity, goals, impulsivity, nonacceptance, and regulation strategies. Participants respond to items on a 5-point Likert scale. Higher scores suggest more severe problems with emotion regulation. The highest possible score is 80 and the lowest possible score is 16.

    Measured: The Difficulties in Emotion Regulation Scale will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  2. Changes in parenting/caregiving stress from pre-intervention to post-intervention - Parenting Stress Index (PSI; Short form).

    36-item self-report measure filled out by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. There are 3 sub categories. Responses to each item in a sub-category are totalled and then the 3 subcategory scores are summed to represent a total stress score. Higher scores indicated higher levels of parenting stress. Normal scores fall within the 15th to 85th percentile, and scores above the 85th percentile represent clinically elevated levels of stress.

    Measured: The Parenting Stress Index will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  3. Changes in recent stressful events from pre-intervention to post-intervention - Recent Stressful Events (RSE).

    Assesses the frequency of stressful events in the past month and past year. Developed based on recommendations from the JBP research network on toxic stress at the Harvard's Center on the Developing Child.

    Measured: The Recent Stressful Events Measure will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  4. Changes in parental/caregiver depressive symptoms throughout the intervention - Patient Health Questionnaire - 9 (PHQ-9).

    A measure that assesses depressive symptoms using 8-items that align with diagnostic criteria. For the purposes of this study item 9 (regarding suicide ideation) will not be used.

    Measured: The Patient Health Questionnaire - 9 will be completed by participants weekly throughout the intervention (approx. 16 times throughout 16 weeks).

  5. Changes in parental/caregiver perception of social support from pre-intervention to post-intervention - Multidimensional Scale of Perceived Social Support (MSPSS).

    A 12-item measure that assesses perceived social supports in parents/caregivers. Participants respond to items on a 7-point Likert scale. Higher scores are indicative of increased perception of social support.

    Measured: The Multidimensional Scale of Perceived Social Support will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  6. Changes in parenting/caregiving quality from pre-intervention to post-intervention - Coping with Children's Negative Emotions Scale (CCNES).

    A measure with 12 items (each with 6 sub-items for a total of 72 responses) that assesses parenting quality across supportive and unsupportive dimensions. Participants respond to items on a 7-point Likert scale.

    Measured: The Coping with Children's Negative Emotions Scale will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  7. Changes in perceived parental/caregiver resilience from pre-intervention to post-intervention - Connor-Davidson Resilience Scale 2 (CD-RISC 2).

    A 2-item measure that assesses self-reported resilience over the past month. Participants respond to items on a 5-point Likert scale. Higher scores are indicative of increased perceived resilience.

    Measured: The Connor-Davidson Resilience Scale 2 will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  8. Changes in various aspects of parenting/caregiving from pre-intervention to post-intervention - Parenting Scale (PS).

    A 30-item measure that assesses various aspects of parenting, including overreactivity, laxness, and verbosity. Participants are asked about their parenting style during the past two months.

    Measured: The Parenting Scale will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  9. Changes in parental/caregiving spanking from pre-intervention to post-intervention - Parental Spanking.

    A single-item measure assessing the frequency of spanking on a child's bottom during a typical year (restricted to age 2-5 years due to mandatory reporting guidelines for child maltreatment).

    Measured: The Parental Spanking Measure will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  10. Changes in family resources from pre-intervention to post-intervention - Family Resource Scale - Revised (FRS-R).

    A 29-item measure assessing whether families have adequate resources to meet the needs of the family as a whole as well as individual needs within the family. Participants respond to items on a 6-point Likert scale.

    Measured: The Revised Family Resource Scale will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  11. Changes in marital functioning from pre-intervention to post-intervention - Revised Dyadic Adjustment Scale (RDAS).

    A 14-item measure that assesses marital functioning across three subscales: cohesion, consensus, and satisfaction. Participants respond to items on a 6-point Likert scale.

    Measured: The Revised Dyadic Adjustment Scale will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

  12. Changes in Parental/Caregiver Functioning from pre-intervention to post-intervention.

    Open-ended questions regarding parental/caregiver functioning and unmet needs.

    Measured: open-ended questions regarding parent/caregiver functioning will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start14 Apr 2021
  3. Primary completion11 Oct 2021
  4. Study completion11 Oct 2021

Resources

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
Randomised
Intervention model
Parallel groups
Model description
The study will recruit a group of caregivers in which the caregiver meets the current criteria for elevated symptoms of psychological distress as measured by a score of 9 and above on the Patient Health Questionnaire 9-item. Eligible caregivers (mothers, fathers, guardians) will be randomly assigned to one of two intervention arms, which will occur concurrently over 16-weeks. One arm will incorporate intervention materials from Dialectical Behavior Therapy (DBT) and parent skills training, while another will provide community family support services as usual.
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893850
Sponsor's protocol ID
BRIDGE KIDTHINK
Status last verified
Jun 2021
First submitted
14 May 2021
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BRIDGE Therapy Program and Community Services as Usual Clinical Referral list in people with Depression and Child Development, run by University of Manitoba 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 5 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: finished, as of the sponsor's last update on 3 Jul 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the Child Behaviour Checklist (CBCL) from pre-intervention to post-intervention. (time frame: The Child Behaviour Checklist will be completed by participants at baseline prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 16 weeks after baseline).). The study lists 3 primary outcomes in all. 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 3 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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