Clinical trial NCT04893850: Building Regulations in Dual Generations at KIDTHINK
Official title: Building Regulations in Dual Generations at KIDTHINK
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Child Development
Self-regulation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in the Child Behaviour Checklist (CBCL) from pre-intervention to post-intervention.
timeFrame: 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).
measure: Changes in the Life Events Checklist (LEC) from pre-intervention to post-intervention.
timeFrame: 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).
measure: Changes in Child Functioning from pre-intervention to post-intervention.
timeFrame: 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:
measure: Changes in parent/caregiver emotion regulation from pre-intervention to post-intervention - Difficulties in Emotion Regulation Scale (DERS-16).
timeFrame: 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).
measure: Changes in parenting/caregiving stress from pre-intervention to post-intervention - Parenting Stress Index (PSI; Short form).
timeFrame: 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).
measure: Changes in recent stressful events from pre-intervention to post-intervention - Recent Stressful Events (RSE).
timeFrame: 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).
measure: Changes in parental/caregiver depressive symptoms throughout the intervention - Patient Health Questionnaire - 9 (PHQ-9).
timeFrame: The Patient Health Questionnaire - 9 will be completed by participants weekly throughout the intervention (approx. 16 times throughout 16 weeks).
measure: Changes in parental/caregiver perception of social support from pre-intervention to post-intervention - Multidimensional Scale of Perceived Social Support (MSPSS).
timeFrame: 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).
measure: Changes in parenting/caregiving quality from pre-intervention to post-intervention - Coping with Children's Negative Emotions Scale (CCNES).
timeFrame: 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).
measure: Changes in perceived parental/caregiver resilience from pre-intervention to post-intervention - Connor-Davidson Resilience Scale 2 (CD-RISC 2).
timeFrame: 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).
measure: Changes in various aspects of parenting/caregiving from pre-intervention to post-intervention - Parenting Scale (PS).
timeFrame: 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).
measure: Changes in parental/caregiving spanking from pre-intervention to post-intervention - Parental Spanking.
timeFrame: 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).
measure: Changes in family resources from pre-intervention to post-intervention - Family Resource Scale - Revised (FRS-R).
timeFrame: 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).
measure: Changes in marital functioning from pre-intervention to post-intervention - Revised Dyadic Adjustment Scale (RDAS).
timeFrame: 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).
measure: Changes in Parental/Caregiver Functioning from pre-intervention to post-intervention.
timeFrame: 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 outcomes:
measure: Changes in child socioemotional and behavioural functioning from pre-intervention to post-intervention - Strengths and Difficulties Questionnaire (SDQ).
timeFrame: 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).
measure: Changes in specific parenting/caregiving behaviours and strategies - Parenting Young Children (PARYC).
timeFrame: 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).
measure: Changes in parent/caregiver reports of child behaviours - Parent Daily Report - Revised Version.
timeFrame: The Revised Parent Daily Report will be completed by participants weekly throughout the intervention (approx. 16 times throughout 16 weeks).
Locations:
city: Winnipeg
country: Canada
facility: The University of Manitoba - Department of Psychology
state: Manitoba
Study officials:
References: