Clinical trial NCT05032742: Parenting Stress mHealth
Official title: Reducing Parenting Stress to Facilitate Justice-Involved Youth's Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Keywords: parenting stress
juvenile justice
digital health
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 randomized controlled trial; and 4) understand systems-level factors that could influence eventual system adoption and sustainability.

Eligibility 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 in a juvenile detention center or correctional facility, mandated by the juvenile justice system to a congregate out-of-home placement (e.g., group home);
* 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.

Primary outcomes:
measure: Interpersonal Mindfulness in Parenting Scale (Mindful Parenting)
timeFrame: 3 months post baseline
measure: Interpersonal Mindfulness in Parenting Scale (Mindful Parenting)
timeFrame: 6 months post baseline
measure: Stress Index for Parents of Adolescents (Parenting Stress)
timeFrame: 3 months post baseline
measure: Stress Index for Parents of Adolescents (Parenting Stress)
timeFrame: 6 months post baseline
measure: Parenting Self-Efficacy
timeFrame: 3 months post baseline
measure: Parenting Self-Efficacy
timeFrame: 6 months post baseline
measure: Child and Adolescent Services Assessment (Barriers to Youth Treatment)
timeFrame: 3 months post baseline
measure: Child and Adolescent Services Assessment (Barriers to Youth Treatment)
timeFrame: 6 months post baseline
measure: Motivation for Youth Treatment
timeFrame: 3 months post baseline
measure: Motivation for Youth Treatment
timeFrame: 6 months post baseline
Secondary outcomes:
measure: Youth Treatment Engagement
timeFrame: 3 months post baseline
measure: Youth Treatment Engagement
timeFrame: 6 months post baseline
Other outcomes:
measure: Caregiver Mental Health & Substance Use
timeFrame: 3 months post baseline
measure: Caregiver Mental Health & Substance Use
timeFrame: 6 months post baseline
measure: mHealth Application Acceptability
timeFrame: 3 months post baseline
measure: Caregiver Qualitative Interview
timeFrame: 3 months post baseline
measure: Youth Qualitative Interview
timeFrame: After youth's release to the community within study period (estimated 2 years or less)
Locations:
city: San Francisco
country: United States
facility: UCSF Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Johanna B Folk, PhD
role: PRINCIPAL_INVESTIGATOR
References: