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Building Regulations in Dual Generations at KIDTHINK

Primary Purpose

Depression, Child Development, Self-regulation

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BRIDGE Therapy Program
Community Services as Usual Clinical Referral list
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • The University of Manitoba - Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BRIDGE-KIDTHINK Condition

Services as Usual Condition

Arm Description

Caregivers 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.

Caregivers 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.

Outcomes

Primary Outcome Measures

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.
Changes in the Life Events Checklist (LEC) from pre-intervention to post-intervention.
34-item measure that assesses adverse life experiences of children.
Changes in Child Functioning from pre-intervention to post-intervention.
Open-ended questions regarding child functioning for qualitative analysis.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
Changes in Parental/Caregiver Functioning from pre-intervention to post-intervention.
Open-ended questions regarding parental/caregiver functioning and unmet needs.

Full Information

First Posted
May 14, 2021
Last Updated
June 16, 2021
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT04893850
Brief Title
Building Regulations in Dual Generations at KIDTHINK
Official Title
Building Regulations in Dual Generations at KIDTHINK
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Child Development, Self-regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BRIDGE-KIDTHINK Condition
Arm Type
Experimental
Arm Description
Caregivers 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.
Arm Title
Services as Usual Condition
Arm Type
Experimental
Arm Description
Caregivers 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.
Intervention Type
Behavioral
Intervention Name(s)
BRIDGE Therapy Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community Services as Usual Clinical Referral list
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the Child Behaviour Checklist (CBCL) from pre-intervention to post-intervention.
Description
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.
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).
Title
Changes in the Life Events Checklist (LEC) from pre-intervention to post-intervention.
Description
34-item measure that assesses adverse life experiences of children.
Time Frame
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).
Title
Changes in Child Functioning from pre-intervention to post-intervention.
Description
Open-ended questions regarding child functioning for qualitative analysis.
Time Frame
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 Outcome Measure Information:
Title
Changes in parent/caregiver emotion regulation from pre-intervention to post-intervention - Difficulties in Emotion Regulation Scale (DERS-16).
Description
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.
Time Frame
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).
Title
Changes in parenting/caregiving stress from pre-intervention to post-intervention - Parenting Stress Index (PSI; Short form).
Description
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.
Time Frame
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).
Title
Changes in recent stressful events from pre-intervention to post-intervention - Recent Stressful Events (RSE).
Description
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.
Time Frame
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).
Title
Changes in parental/caregiver depressive symptoms throughout the intervention - Patient Health Questionnaire - 9 (PHQ-9).
Description
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.
Time Frame
The Patient Health Questionnaire - 9 will be completed by participants weekly throughout the intervention (approx. 16 times throughout 16 weeks).
Title
Changes in parental/caregiver perception of social support from pre-intervention to post-intervention - Multidimensional Scale of Perceived Social Support (MSPSS).
Description
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.
Time Frame
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).
Title
Changes in parenting/caregiving quality from pre-intervention to post-intervention - Coping with Children's Negative Emotions Scale (CCNES).
Description
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.
Time Frame
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).
Title
Changes in perceived parental/caregiver resilience from pre-intervention to post-intervention - Connor-Davidson Resilience Scale 2 (CD-RISC 2).
Description
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.
Time Frame
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).
Title
Changes in various aspects of parenting/caregiving from pre-intervention to post-intervention - Parenting Scale (PS).
Description
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.
Time Frame
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).
Title
Changes in parental/caregiving spanking from pre-intervention to post-intervention - Parental Spanking.
Description
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).
Time Frame
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).
Title
Changes in family resources from pre-intervention to post-intervention - Family Resource Scale - Revised (FRS-R).
Description
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.
Time Frame
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).
Title
Changes in marital functioning from pre-intervention to post-intervention - Revised Dyadic Adjustment Scale (RDAS).
Description
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.
Time Frame
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).
Title
Changes in Parental/Caregiver Functioning from pre-intervention to post-intervention.
Description
Open-ended questions regarding parental/caregiver functioning and unmet needs.
Time Frame
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).
Other Pre-specified Outcome Measures:
Title
Changes in child socioemotional and behavioural functioning from pre-intervention to post-intervention - Strengths and Difficulties Questionnaire (SDQ).
Description
A 25-item measure that assesses child and socioemotional behavioural functioning over the last six months or current school year. Parents/caregivers respond to items on a 3-point Likert scale.
Time Frame
The Strengths and Difficulties Questionnaire 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).
Title
Changes in specific parenting/caregiving behaviours and strategies - Parenting Young Children (PARYC).
Description
A 21-item measure assessing specific parenting behaviours and strategies during the last month. Parents/caregivers respond to items on a 5-point Likert scale.
Time Frame
The Parenting Young Children 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).
Title
Changes in parent/caregiver reports of child behaviours - Parent Daily Report - Revised Version.
Description
Parent/caregiver reports of child behaviours in the past 24 hours. Participants respond to items on a 3-point Likert scale indicating whether a thought/behaviour occurred for their child, and whether it was stressful for them as the parent/caregiver.
Time Frame
The Revised Parent Daily Report will be completed by participants weekly throughout the intervention (approx. 16 times throughout 16 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
The University of Manitoba - Department of Psychology
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Cameron, PhD
Phone
431-977-0550
Email
emily.cameron@umanitoba.ca
First Name & Middle Initial & Last Name & Degree
Leslie E. Roos, PhD
Email
leslie.roos@umanitoba.ca
First Name & Middle Initial & Last Name & Degree
Leslie E. Roos, PhD
First Name & Middle Initial & Last Name & Degree
Emily Cameron, PhD

12. IPD Sharing Statement

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Building Regulations in Dual Generations at KIDTHINK

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