Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques

Stress, Psychological Clinical Trial

— SPYKids  

Official title:

Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05857865
• Other study ID #: SPYKids
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: July 2023

Study information

• Verified date: May 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Family Dynamics
• Mental Health Issue
• Stress, Emotional
• Stress, Psychological

Intervention

Behavioral:
• SPYKids
SSIs will be tailored to the parent areas of primary concern as identified in the pre-questionnaire. Participants will meet with the parent coach in a virtual 90-minute session to discuss coping strategies relevant to the identified concerns. Content will be informed by the baseline questionnaire and include psychoeducation with an explanation of 1 or 2 skills to manage a primary mental health issue (e.g., Emotion Regulation, Distress Tolerance, Communication), a brief practice of the skills (as appropriate), and an action plan for the family to apply the skills at home. Families will also be provided with recommendations for relevant services from our family-focused resource list. Please note, the session length may be extended to 120 minutes if an interpreter is required in order to provide equal opportunity for understanding the session content.

Other:
• Services as Usual (SAU)
Participants will receive links to the Manitoba 211 websites and a local organization's resource website with resources for adults and children. This resource is used to locate crisis, distress, and support phone lines, and counselling. Following completion of the 3-month survey, participants will receive a lab-developed comprehensive list of resources (also provided to participants in the SPYKids arm).

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Children's Hospital Research Institute of Manitoba, Specialized Services for Children and Youth (SCCY), Winnipeg, Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in parental/caregiver feelings of hope from pre- to post-intervention - Beck Hopelessness Scale - 4 (BHS)	A self-report measure that uses 20 true or false statements to assess feelings about the future, loss of motivation, and expectations. Higher total scores indicate greater hopelessness.	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).
Other	Changes in parental/caregiver perceived control/agency -- Perceived Control Single item (AGENCY)	A single-item scale that measures perceived control of parents/caregivers by asking parents to rate their perceived sense of control on a scale from 1 to 10. Higher scores indicate less perceived control/agency.	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).
Other	Changes in parental/caregiver readiness to change - Readiness Ruler	A visual tool for parents/caregivers to rate the importance of making a change, their readiness to change, and confidence to change/take action on a 1-10 scale. Higher scores indicate ongoing attempts at changing.	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).
Other	Changes in parental/caregiver problem-solving strategies	A measure that assesses the extent to which parents/caregivers are able to solve problems compared to pre-intervention on a 5-point scale from "much less able to solve problems" to "a lot more able to solve problems." Higher scores indicate more self-efficacy.	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).
Other	Changes in parental/caregiver perceived change in hopelessness	A measure that assesses the extent to which parents/caregivers perceive changes in hopelessness compared to pre-intervention on a 5-point scale from "much more hopeless" to "a lot less hopeless." Higher scores indicate more hopefulness.	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).
Primary	Parent coach adherence to intervention protocol using the Fidelity Checklist	29-item measure that assesses the extent to which the parent coach followed intervention protocols. Items are measured on a 5-point Likert scale with higher scores indicating greater adherence to protocols.	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).
Primary	Feedback questionnaires pertaining to participant satisfaction with intervention protocol	10-item questionnaire that measures parent satisfaction with intervention protocol. Participants respond to open-ended items regarding their satisfaction with the format of the SSI. This measure is qualitative in nature and no scores are generated.	The feedback questionnaires will be completed by participants immediately following the intervention (approximately 2 weeks after baseline).
Primary	Participant satisfaction with SSI format using the Program Feedback Scale	4-item questionnaire used to measure participant satisfaction with SSI. Participants respond to items on a 5-point Likert scale and are asked to rate the extent to which they feel the SSI will help with their identified problem. Higher scores indicate greater satisfaction.	The Program Feedback Scale will be completed by participants immediately following the intervention (approximately 2 weeks after baseline).
Primary	Changes in child socioemotional and behavioural functioning between the SPYKids group compared with the SAU group - Strengths and Difficulties Questionnaire (SDQ)	A 25-item instrument developed to detect psychosocial problems in children aged 3-16 years. A value is given to each selection of "not true," somewhat true," and "certainly true." It measures five factors: emotional problems, conduct problems, hyperactivity/inattention problems, peer problems, and prosocial behaviour. All subscales include five items and range from 0-10. A total score can be summed from the first four factors; the total score ranges from 0-40, with higher scores indicating greater difficulties. Scores on the fifth factor of prosocial behaviour range from 0-10, with a lower score on this scale being less favourable.	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	Changes in child socioemotional and behavioural functioning from pre- to 3- month post-intervention - Strengths and Difficulties Questionnaire (SDQ)	A 25-item instrument developed to detect psychosocial problems in children aged 3-16 years. A value is given to each selection of "not true," somewhat true," and "certainly true." It measures five factors: emotional problems, conduct problems, hyperactivity/inattention problems, peer problems, and prosocial behaviour. All subscales include five items and range from 0-10. A total score can be summed from the first four factors; the total score ranges from 0-40, with higher scores indicating greater difficulties. Scores on the fifth factor of prosocial behaviour range from 0-10, with a lower score on this scale being less favourable.	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).
Secondary	Changes in parenting/caregiving stress from pre- to post-intervention - Parenting Stress Index (PSI; Short form)	A 36-item self-report measure completed by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. Responses to each item in a sub-category are totalled to calculate three subcategory scores, which are summed to represent a total parenting stress score. Higher scores indicate 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 PSI will be completed by participants at baseline, approximately 1 month post-intervention and at 3 months post-intervention (approximately 12 weeks from baseline).
Secondary	Changes in parental/caregiver depressive symptoms from pre- to post-intervention - Patient Health Questionnaire - 9 (PHQ-9)	A measure that assesses depressive symptoms using 8 items that align with diagnostic criteria with total possible scores ranging from 0 to 27, where higher scores are indicative of more severe symptoms.	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).
Secondary	Changes in parent anxiety symptoms -- Generalized Anxiety Disorder - 7 item scale (GAD-7)	A brief self-report measure to screen for generalized anxiety disorder. Scores range from 0-21, with higher scores indicating more severe anxiety.	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).
Secondary	Changes in parent anger symptoms -- The Patient Records and Outcome Management Information System (PROMIS) Emotional Distress - Anger - Short-Form	A brief self-report measure used to assess the domain of anger. The items are measured on a 5-point Likert scale from "never" (1) to "always" (5). Total scores range from 5 to 25, with higher scores indicating more severe anger.	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).