Building Regulations in Dual Generations at KIDTHINK

Depression Clinical Trial

Official title:

Building Regulations in Dual Generations at KIDTHINK

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893850
• Other study ID #: BRIDGE KIDTHINK
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: June 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Child Development
• Depression
• Self-regulation

Intervention

Behavioral:
• BRIDGE Therapy Program
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 list
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.

Locations

Country	Name	City	State
Canada	The University of Manitoba - Department of Psychology	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in child socioemotional and behavioural functioning from pre-intervention to post-intervention - Strengths and Difficulties Questionnaire (SDQ).	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.	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).
Other	Changes in specific parenting/caregiving behaviours and strategies - Parenting Young Children (PARYC).	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.	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).
Other	Changes in parent/caregiver reports of child behaviours - Parent Daily Report - Revised Version.	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.	The Revised Parent Daily Report will be completed by participants weekly throughout the intervention (approx. 16 times throughout 16 weeks).
Primary	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.	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).
Primary	Changes in the Life Events Checklist (LEC) from pre-intervention to post-intervention.	34-item measure that assesses adverse life experiences of children.	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).
Primary	Changes in Child Functioning from pre-intervention to post-intervention.	Open-ended questions regarding child functioning for qualitative analysis.	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	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	The Patient Health Questionnaire - 9 will be completed by participants weekly throughout the intervention (approx. 16 times throughout 16 weeks).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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).	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	Changes in Parental/Caregiver Functioning from pre-intervention to post-intervention.	Open-ended questions regarding parental/caregiver functioning and unmet needs.	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).