Clinical trial NCT05857865: Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques
Official title: Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Family Dynamics
Stress, Psychological
Stress, Emotional
Child Development
Keywords: single-session intervention
therapy
neurodevelopmental disorder
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Specialized Services for Children and Youth (SCCY), Winnipeg, Manitoba
name: Children's Hospital Research Institute of Manitoba
First posted: 2023-05-15
Enrollment: 70
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 caregivers with young children who have a neurodevelopmental disorder and who are currently on the waitlist for relevant services. Eligible caregivers (mothers, fathers, guardians) will be randomly assigned to either participate in one 90-minute single session intervention (SSI) in which a strategy will be developed to address a primary mental health concern or receive community family support services as usual.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare outcomes between participants in the single-session psychotherapy for young kids (SPYKids) conditions and participants in the services as usual (SAU) condition. The main questions it aims to answer are:

* What is the feasibility and acceptability of SPYKids compared to services as usual?
* What are the changes in child mental health between the SPYKids group compared with the SAU group?

Participants will

* Fill out questionnaires at baseline, immediately post-program, approximately one month after the baseline assessment, and three months after the baseline assessment
* Meet with a parent coach in a virtual 90-minute session to discuss coping strategies relevant to their identified concerns

Researchers will compare participants in the SPYKids group with participants in the Services as Usual group to see if there are changes in child well-being, parent well-being, and parent self-efficacy.

Detailed description: The coronavirus disease of 2019 (COVID-19) pandemic has contributed to elevated stress experienced by parents and caregivers of children with neurodevelopmental disorders (NDDs) resulting in increased demand for relevant specialized services. Current waitlists for NDD assessments following referral are approximately 12 months in Manitoba, with similar lengths of 6-30 months across Canada, which can result in children aging out of some early intervention services. The SPYKids program aims to provide families with help, encouragement, and motivation to cope with family stressors while on waitlists at local organizations through a single-session consultation model. A single-session intervention (SSI) is designed to increase parental ability to understand and address emergent mental health problems by teaching parents how to support children's emotional development and impulse control to reduce mental health problems, while reducing high-conflict parenting that can worsen mental health over time. The present study aims to test the feasibility and value of SSIs in a 2-arm randomized control trial which will include one 90-minute consultation with psychoeducation, identification of a primary mental health issue, an opportunity to practice the skills, and an action plan for the family to apply the skills independently. The long-term goal is to create an evidence-based accessible and rapidly deployable intervention to promote well-being for children with NDDs and their families.

Eligibility criteria: Inclusion Criteria:

* Manitoba resident with a Manitoba IP address
* Caregiver must be at least 18 years old
* Primary caregiver of 2-5-year-old child
* Must be on a waitlist for neurodevelopmental services in Manitoba

Exclusion Criteria:

* Living outside of Manitoba and/or internet protocol (IP) address outside of Manitoba
* Child is outside of the 2-5-year-old age range
* The caregiver is younger than 18 years old
* Not on a waitlist for neurodevelopmental services

Primary outcomes:
measure: Parent coach adherence to intervention protocol using the Fidelity Checklist
timeFrame: This measure is completed approximately 2 weeks after baseline. The first 6 items are completed by the parent coach at the end of the intervention and the last 23 items are completed immediately following the intervention (i.e., within a few minutes).
measure: Feedback questionnaires pertaining to participant satisfaction with intervention protocol
timeFrame: The feedback questionnaires will be completed by participants immediately following the intervention (approximately 2 weeks after baseline).
measure: Participant satisfaction with SSI format using the Program Feedback Scale
timeFrame: The Program Feedback Scale will be completed by participants immediately following the intervention (approximately 2 weeks after baseline).
measure: Changes in child socioemotional and behavioural functioning between the SPYKids group compared with the SAU group - Strengths and Difficulties Questionnaire (SDQ)
timeFrame: The SDQ will be completed by participants at baseline, approximately 6 weeks from baseline (i.e., 1-month post-intervention for SPYKids group), and at 3 months post-intervention (approximately 12 weeks from baseline).
Secondary outcomes:
measure: Changes in child socioemotional and behavioural functioning from pre- to 3- month post-intervention - Strengths and Difficulties Questionnaire (SDQ)
timeFrame: The SDQ will be completed by participants at baseline, approximately 1 month post-intervention and at 3 months post-intervention (approximately 12 weeks from baseline).
measure: Changes in parenting/caregiving stress from pre- to post-intervention - Parenting Stress Index (PSI; Short form)
timeFrame: The PSI will be completed by participants at baseline, approximately 1 month post-intervention and at 3 months post-intervention (approximately 12 weeks from baseline).
measure: Changes in parental/caregiver depressive symptoms from pre- to post-intervention - Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: The PHQ-9 will be completed by participants at baseline, approximately 1 month post-intervention and at 3 months post-intervention (approximately 12 weeks from baseline).
measure: Changes in parent anxiety symptoms -- Generalized Anxiety Disorder - 7 item scale (GAD-7)
timeFrame: The GAD-7 will be completed by participants at baseline, approximately 1 month post-intervention and at 3 months post-intervention (approximately 12 weeks from baseline).
measure: Changes in parent anger symptoms -- The Patient Records and Outcome Management Information System (PROMIS) Emotional Distress - Anger - Short-Form
timeFrame: The PROMIS-Anger will be completed by participants at baseline, approximately 1 month post-intervention and at 3 months post-intervention (approximately 12 weeks from baseline).
Other outcomes:
measure: Changes in parental/caregiver feelings of hope from pre- to post-intervention - Beck Hopelessness Scale - 4 (BHS)
timeFrame: The BHS will be completed by participants at baseline, approximately 1 month post-intervention and at 3 months post-intervention (approximately 12 weeks from baseline).
measure: Changes in parental/caregiver perceived control/agency -- Perceived Control Single item (AGENCY)
timeFrame: The AGENCY will be completed by participants at baseline, immediately post-intervention (approximately 2 weeks after baseline), 1 month post-intervention, 3 months post-intervention (approximately 12 weeks from baseline).
measure: Changes in parental/caregiver readiness to change - Readiness Ruler
timeFrame: The Readiness Ruler will be completed by participants at baseline, immediately post-intervention (approximately 2 weeks after baseline), 1 month post-intervention, 3 months post-intervention (approximately 12 weeks from baseline).
measure: Changes in parental/caregiver problem-solving strategies
timeFrame: The problem-solving strategies scale will be completed by participants immediately post-intervention (approximately 2 weeks after baseline), 1 month post-intervention, 3 months post-intervention (approximately 12 weeks from baseline).
measure: Changes in parental/caregiver perceived change in hopelessness
timeFrame: The perceived change in hopelessness scale will be completed by participants immediately post-intervention (approximately 2 weeks after baseline), 1 month post-intervention, 3 months post-intervention (approximately 12 weeks from baseline).
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: Assistant professor
name: Leslie E Roos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Postdoctoral fellow
name: Emily Cameron, PhD
role: PRINCIPAL_INVESTIGATOR
References: