Mental Health IssueSPYKidsNCT05857865
Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques
A study testing SPYKids and Services as Usual (SAU) in people with Mental Health Issue and Family Dynamics, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Family Dynamics, Stress, Psychological
- What is being tested?
- SPYKids and Services as Usual (SAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2023to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Mental Health Issue, Family Dynamics, Stress, Psychological, Stress, Emotional, Child Development
- Being tested
- SPYKids, Services as Usual (SAU)
- Keywords
- single-session intervention, therapy, neurodevelopmental disorder
- Medical subject headings
- Stress, Psychological, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPYKidsBehavioural
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.
Services as Usual (SAU)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Caregivers in this group will participate in one 90-minute session delivered by a parenting coach via Zoom. This group will be asked to complete questionnaires at baseline, immediately post-program, approximately one month after the baseline assessment, and three months after the baseline assessment. Receives: Behavioral: SPYKids |
| Services as Usual (SAU) | Experimental | Caregivers in this group will not participate in a single-session intervention (SSI). Rather, this group will receive services as usual on the Specialized Services for Children and Youth (SCCY) waitlist. This group will be asked to complete questionnaires at baseline, approximately one month after the baseline assessment, and three months after the baseline assessment. Receives: Other: Services as Usual (SAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: The feedback questionnaires will be completed by participants immediately following the intervention (approximately 2 weeks after baseline).
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.
Measured: The Program Feedback Scale will be completed by participants immediately following the intervention (approximately 2 weeks after baseline).
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.
Measured: 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 (5)
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start12 Jan 2023
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Research Institute of Manitoba, Specialized Services for Children and Youth
- Responsible party
- Principal investigator, Leslie E. Roos, University of Manitoba
- Investigators
- Leslie E Roos, PhD, Principal investigator, Assistant professorEmily Cameron, PhD, Principal investigator, Postdoctoral fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857865
- Sponsor's protocol ID
- SPYKids
- Acronym
- SPYKids
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data (e.g. standardized questionnaire responses, aggregated program use data, sociodemographics linked to an identifier number) may be made available on public data platforms such as open science framework or a requirement by a granting agency or journal.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques
- ClinicalTrials.gov ID
- NCT05857865
- Acronym / sponsor ID
- SPYKids / SPYKids
- Conditions
- Mental Health Issue, Family Dynamics, Stress, Psychological, Stress, Emotional, Child Development
- Keywords
- single-session intervention, therapy, neurodevelopmental disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Children's Hospital Research Institute of Manitoba, Specialized Services for Children and Youth
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: SPYKidsCaregivers in this group will participate in one 90-minute session delivered by a parenting coach via Zoom. This group will be asked to complete questionnaires at baseline, immediately post-program, approximately one month after the baseline assessment, and three months after the baseline assessment. |
| Services as Usual (SAU) | Experimental | Other: Services as Usual (SAU)Caregivers in this group will not participate in a single-session intervention (SSI). Rather, this group will receive services as usual on the Specialized Services for Children and Youth (SCCY) waitlist. This group will be asked to complete questionnaires at baseline, approximately one month after the baseline assessment, and three months after the baseline assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPYKidsSSIs 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. | Behavioural | Experimental |
| 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). | Other | Services as Usual (SAU) |
Primary outcome
Parent coach adherence to intervention protocol using the Fidelity Checklist
Time frame: 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).
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.
Feedback questionnaires pertaining to participant satisfaction with intervention protocol
Time frame: The feedback questionnaires will be completed by participants immediately following the intervention (approximately 2 weeks after baseline).
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.
Participant satisfaction with SSI format using the Program Feedback Scale
Time frame: The Program Feedback Scale will be completed by participants immediately following the intervention (approximately 2 weeks after baseline).
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.
Changes in child socioemotional and behavioural functioning between the SPYKids group compared with the SAU group - Strengths and Difficulties Questionnaire (SDQ)
Time frame: 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).
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.
5 secondary outcomes
Changes in child socioemotional and behavioural functioning from pre- to 3- month post-intervention - Strengths and Difficulties Questionnaire (SDQ)
Time frame: 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).
Changes in parenting/caregiving stress from pre- to post-intervention - Parenting Stress Index (PSI; Short form)
Time frame: 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).
Changes in parental/caregiver depressive symptoms from pre- to post-intervention - Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 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).
Changes in parent anxiety symptoms -- Generalized Anxiety Disorder - 7 item scale (GAD-7)
Time frame: 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).
Changes in parent anger symptoms -- The Patient Records and Outcome Management Information System (PROMIS) Emotional Distress - Anger - Short-Form
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data (e.g. standardized questionnaire responses, aggregated program use data, sociodemographics linked to an identifier number) may be made available on public data platforms such as open science framework or a requirement by a granting agency or journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie E Roos, PhD principal investigator
Assistant professor
Emily Cameron, PhD principal investigator
Postdoctoral fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPYKids and Services as Usual (SAU) in people with Mental Health Issue and Family Dynamics, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent coach adherence to intervention protocol using the Fidelity Checklist (time frame: 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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.