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Parenting Stress mHealth

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ClinicalTrials.gov Identifier: NCT05032742
Recruitment Status : Not yet recruiting
First Posted : September 2, 2021
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Parenting stress is a well-documented barrier to youth engagement in community-based substance use treatment. The current project aims to develop and evaluate a mobile health parenting stress intervention for caregivers of justice-involved youth, a population with high rates of substance use and low rates of treatment engagement.

Condition or disease Intervention/treatment Phase
Stress Behavioral: mHealth parenting stress app Not Applicable

Detailed Description:
Justice-involved youth exhibit high rates of substance use and mental health symptoms, yet few receive treatment during detention or community re-entry. Once released into the community, caregivers must facilitate youth's treatment engagement, mobilizing significant resources and facing many barriers (e.g., transportation, mistrust) to do so. Parenting stress, which is heightened during youth detention and community reentry, is associated with greater perceived barriers to treatment, less youth therapeutic change throughout treatment, and premature treatment dropout. Addressing parenting stress improves youth treatment engagement and outcomes among youth exhibiting antisocial behavior, yet given the many barriers to treatment, novel approaches to intervention are needed; mobile health (mHealth) technology is one promising approach. Caregivers of justice-involved youth and system stakeholders are interested in mHealth treatment and mHealth addresses instrumental barriers (e.g., transportation) to treatment. Advances in technology and community engaged research allow for active stakeholder collaboration in mHealth application development, with no technological expertise required, through participatory informatics; caregiver involvement increases the likelihood the intervention will be relevant and efficacious. The purpose of this mixed-methods K23 study is to 1) develop a mHealth parenting stress intervention using participatory informatics; 2) assess the feasibility and acceptability of the participatory informatics approach and the intervention; 3) evaluate the intervention's preliminary efficacy in reducing parenting stress and increasing youth engagement in substance use or dual diagnosis treatment post-detention through a pilot RCT; and 4) understand systems-level factors that could influence eventual system adoption and sustainability.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Parenting Stress to Facilitate Justice-Involved Youth's Treatment
Estimated Study Start Date : April 1, 2023
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: mHealth parenting stress app
mHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement.
Behavioral: mHealth parenting stress app
mHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement.

No Intervention: Standard of care
Caregiver participants will receive an informational brochure describing ways to support one's adolescent during detention and community reentry and any other usual care.



Primary Outcome Measures :
  1. Interpersonal Mindfulness in Parenting Scale (Mindful Parenting) [ Time Frame: 3 months post baseline ]
    The Interpersonal Mindfulness in Parenting Scale is an 8-item self-report of mindful parenting, including four sub-scales reflecting present-centered emotional awareness in parenting, present-centered attention in parenting, non-reactivity/low reactivity in parenting, and non-judgmental acceptance in parenting that will be used to measure mindful parenting as a construct. Each item is rated on a 1 to 5 scale and items are summed to create sub-scale scores (possible range=8 to 40); higher scores indicate greater mindful parenting.

  2. Interpersonal Mindfulness in Parenting Scale (Mindful Parenting) [ Time Frame: 6 months post baseline ]
    The Interpersonal Mindfulness in Parenting Scale is an 8-item self-report of mindful parenting, including four sub-scales reflecting present-centered emotional awareness in parenting, present-centered attention in parenting, non-reactivity/low reactivity in parenting, and non-judgmental acceptance in parenting that will be used to measure mindful parenting as a construct. Each item is rated on a 1 to 5 scale and items are summed to create sub-scale scores (possible range=8 to 40); higher scores indicate greater mindful parenting.

  3. Stress Index for Parents of Adolescents (Parenting Stress) [ Time Frame: 3 months post baseline ]
    The Stress Index for Parents of Adolescents (SIPA) is a 90-item self-report measure of parenting stress. Items are rated on a 1 to 5 scale and summed to create sub-scale scores; higher scores reflect greater parenting stress.

  4. Stress Index for Parents of Adolescents (Parenting Stress) [ Time Frame: 6 months post baseline ]
    The Stress Index for Parents of Adolescents (SIPA) is a 90-item self-report measure of parenting stress. Items are rated on a 1 to 5 scale and summed to create sub-scale scores (possible range=90 to 450); higher scores reflect greater parenting stress.

  5. Parenting Self-Efficacy [ Time Frame: 3 months post baseline ]
    Parenting Self-Efficacy Scale (PSES) is a 20-item assessment of caregivers' perceived parenting ability across 3 dimensions: parental connection, behavioral influence, and psychological autonomy and used to measure parenting self-efficacy. Items are rated on a scale from 0 to 10 (possible range=0 to 200) with higher scores reflecting greater parenting self-efficacy.

  6. Parenting Self-Efficacy [ Time Frame: 6 months post baseline ]
    Parenting Self-Efficacy Scale (PSES) is a 20-item assessment of caregivers' perceived parenting ability across 3 dimensions: parental connection, behavioral influence, and psychological autonomy and used to measure parenting self-efficacy. Items are rated on a scale from 0 to 10 (possible range=0 to 200) with higher scores reflecting greater parenting self-efficacy.

  7. Child and Adolescent Services Assessment (Barriers to Youth Treatment) [ Time Frame: 3 months post baseline ]
    The Child and Adolescent Services Assessment (CASA) is a parent-report instrument designed to assess the use of behavioral health services by children ages 8 years to 17 years. The CASA includes 31 settings covering inpatient, outpatient, and informal services provided by a variety of child-serving providers and sectors. This instrument collects information on whether a service was ever used, as well as more detailed information (length of stay/number of visits, focus of treatment) on services used in the recent past. Select items from the CASA will assess 16 barriers to youths' services use (e.g., language, transportation, cost, stigma). Caregivers will report whether each barrier was a concern during the 3 months prior to the youths' detention or for follow-ups, in the 3 months since the last assessment (6 months post baseline).

  8. Child and Adolescent Services Assessment (Barriers to Youth Treatment) [ Time Frame: 6 months post baseline ]
    The Child and Adolescent Services Assessment (CASA) is a parent-report instrument designed to assess the use of behavioral health services by children ages 8 years to 17 years. The CASA includes 31 settings covering inpatient, outpatient, and informal services provided by a variety of child-serving providers and sectors. This instrument collects information on whether a service was ever used, as well as more detailed information (length of stay/number of visits, focus of treatment) on services used in the recent past. Select items from the CASA will assess 16 barriers to youths' services use (e.g., language, transportation, cost, stigma). Caregivers will report whether each barrier was a concern during the 3 months prior to the youths' detention or for follow-ups, in the 3 months since the last assessment (6 months post baseline).

  9. Motivation for Youth Treatment [ Time Frame: 3 months post baseline ]
    Motivation for Youth's Treatment Scale (MYTS) is an 8-item measure of intrinsic motivation for youth treatment and assesses a youth and caregiver's problem recognition and treatment readiness. Responses are rated on a 1 to 5 scale and are summed to yield two sub-scale scores (problem recognition: possible range=3 to 15; treatment readiness: possible range=5 to 25). Higher scores reflect higher motivation.

  10. Motivation for Youth Treatment [ Time Frame: 6 months post baseline ]
    Motivation for Youth's Treatment Scale (MYTS) is an 8-item measure of intrinsic motivation for youth treatment and assesses a youth and caregiver's problem recognition and treatment readiness. Responses are rated on a 1 to 5 scale and are summed to yield two sub-scale scores (problem recognition: possible range=3 to 15; treatment readiness: possible range=5 to 25). Higher scores reflect higher motivation.


Secondary Outcome Measures :
  1. Youth Treatment Engagement [ Time Frame: 3 months post baseline ]
    Caregiver report and electronic medical record data on whether youth initiated substance use, mental health, dual diagnosis, or family based treatment in the community (i.e., scheduled appointment, attended first appointment), treatment retention (i.e., number of sessions attended) is collected to measure youth treatment engagement. Caregiver report will provide information on non-MediCal based services (e.g., private pay, 12 step programs) and whether the youth complied with treatment mandated by the juvenile court (e.g., probation requirement), which are not be captured in the centralized electronic medical record system. electronic medical record data will also provide information on services youth participated in that caregivers are not aware of due to minor age consent laws.

  2. Youth Treatment Engagement [ Time Frame: 6 months post baseline ]
    Caregiver report and electronic medical record data on whether youth initiated substance use, mental health, dual diagnosis, or family based treatment in the community (i.e., scheduled appointment, attended first appointment), treatment retention (i.e., number of sessions attended) is collected to measure youth treatment engagement. Caregiver report will provide information on non-MediCal based services (e.g., private pay, 12 step programs) and whether the youth complied with treatment mandated by the juvenile court (e.g., probation requirement), which are not be captured in the centralized electronic medical record system. electronic medical record data will also provide information on services youth participated in that caregivers are not aware of due to minor age consent laws.


Other Outcome Measures:
  1. Caregiver Mental Health & Substance Use [ Time Frame: 3 months post baseline ]
    DSM-5 Cross Cutting Symptom Inventory is a 23-item self-report assessment of psychiatric symptoms (e.g., depression, anxiety, mania, psychosis) and substance use during the past 2 weeks; 1 item regarding suicidal ideation was removed. Items are rated on a scale from 0 to 4 (possible range=0 to 88). Higher scores reflect greater symptom severity.

  2. Caregiver Mental Health & Substance Use [ Time Frame: 6 months post baseline ]
    DSM-5 Cross Cutting Symptom Inventory is a 23-item self-report assessment of psychiatric symptoms (e.g., depression, anxiety, mania, psychosis) and substance use during the past 2 weeks; 1 item regarding suicidal ideation was removed. Items are rated on a scale from 0 to 4 (possible range=0 to 88). Higher scores reflect greater symptom severity.

  3. mHealth Application Acceptability [ Time Frame: 3 months post baseline ]
    Completed by the intervention condition only, the mHealth App Usability Questionnaire for Standalone mHealth Apps is a 21-item self-report assessment of the acceptability (i.e., ease of use, interface and satisfaction, usefulness) of the mHealth application. Items are rated on a scale from 1 to 4 (possible range=21 to 84). Higher scores reflect greater acceptability of the mobile health app intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The following is a description for the inclusion criteria for aims 1 and 2 for caregivers participating in this research study.

Eligible caregivers must be the parent or legal guardian of a youth who is:

  • currently detained;
  • 12-17 years old;
  • has an identified substance use or substance use and co-occurring mental health need;
  • and is scheduled to be released into the community to the care of the enrolled caregiver.

The following is a description for the inclusion criteria for aim 3 for system stakeholders participating in this research study.

Eligible behavioral health providers (e.g., substance use counselor) must:

  • Provide substance use or dual diagnosis treatment justice-involved youth and their caregivers,
  • be over 18 years old,
  • and speak English fluently.

Eligible juvenile probation officers must be:

  • 18 years or older
  • and speak fluent English.

Exclusion Criteria:

Exclusion criteria for all participants includes:

  • lack of proficiency in English
  • and cognitive impairment or active psychosis which precludes provision of informed consent.

Caregivers who do not have access to a device with internet access will also not be eligible as this would preclude them from being able to participate in the mHealth intervention.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032742


Contacts
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Contact: Johanna B Folk, PhD 415-602-9521 johanna.folk@ucsf.edu
Contact: Priyanka P Kulkarni, BA 408-507-8754 priyanka.kulkarni2@ucsf.edu

Locations
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United States, California
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94131
Contact: Johanna Folk, PhD       johanna.folk@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Johanna B Folk, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05032742    
Other Study ID Numbers: K23DA050798 ( U.S. NIH Grant/Contract )
K23DA050798 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
parenting stress
juvenile justice
digital health