Building Regulations in Dual Generations at KIDTHINK

NCT04893850 | Completed

• 1 other identifier: BRIDGE KIDTHINK
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Child Development; Self-regulation

Outcome Measures

Primary Outcomes (3)

• 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).

• 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).

• 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 Outcomes (12)

• Changes in parent/caregiver emotion regulation from pre-intervention to post-intervention - Difficulties in Emotion Regulation Scale (DERS-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).

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

  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).

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

  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).

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

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

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

  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).

Other Outcomes (3)

• Changes in child socioemotional and behavioural functioning from pre-intervention to post-intervention - Strengths and Difficulties Questionnaire (SDQ).

  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).

• Changes in specific parenting/caregiving behaviours and strategies - Parenting Young Children (PARYC).

  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).

• Changes in parent/caregiver reports of child behaviours - Parent Daily Report - Revised Version.

  The Revised Parent Daily Report will be completed by participants weekly throughout the intervention (approx. 16 times throughout 16 weeks).

Study Arms (2)

BRIDGE-KIDTHINK Condition

EXPERIMENTAL

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.

Behavioral: BRIDGE Therapy Program

Services as Usual Condition

EXPERIMENTAL

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.

Behavioral: Community Services as Usual Clinical Referral list

Interventions

BRIDGE Therapy Program BEHAVIORAL

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.

BRIDGE-KIDTHINK Condition

Community Services as Usual Clinical Referral list BEHAVIORAL

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.

Services as Usual Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

The University of Manitoba - Department of Psychology

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Depression; Self-Control

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Departments of Psychology and Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 20, 2021
• Study Start: April 14, 2021
• Primary Completion: October 11, 2021
• Study Completion: October 11, 2021
• Last Updated: July 3, 2025

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)