Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques

NCT05857865 | Unknown

• 1 other identifier: SPYKids
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

single-session intervention; therapy; neurodevelopmental disorder

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• 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).

• 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 Outcomes (5)

• Changes in child socioemotional and behavioural functioning from pre- to 3- month post-intervention - Strengths and Difficulties Questionnaire (SDQ)

  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)

  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)

  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)

  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

  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 (5)

• Changes in parental/caregiver feelings of hope from pre- to post-intervention - Beck Hopelessness Scale - 4 (BHS)

  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).

• Changes in parental/caregiver perceived control/agency -- Perceived Control Single item (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).

• Changes in parental/caregiver readiness to change - Readiness Ruler

  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).

Study Arms (2)

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.

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.

Other: Services as Usual (SAU)

Interventions

SPYKids BEHAVIORAL

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.

Experimental

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).

Services as Usual (SAU)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Specialized Services for Children and Youth (SCCY), Winnipeg, Manitoba: collaborator
• Children's Hospital Research Institute of Manitoba: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Stress, Psychological; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Leslie E Roos, PhD

  Assistant professor

  PRINCIPAL INVESTIGATOR

• Emily Cameron, PhD

  Postdoctoral fellow

  PRINCIPAL INVESTIGATOR

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

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: May 15, 2023
• Study Start: January 12, 2023
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: It would become available when the investigators publish the results of the study, approximately January 2024.
• Access Criteria: Access will be based on the academic journal's level of access and requirements (e.g., subscription). Open access will be preferred at the time of journal selection, as possible, and preprint articles will be submitted online (e.g., psyarxiv.com) as possible based on journal requirements.

Locations

CA (1)