NCT05032742

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Sep 2021Jul 2026

First Submitted

Initial submission to the registry

August 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

4.9 years

First QC Date

August 27, 2021

Last Update Submit

January 9, 2026

Conditions

Keywords

parenting stressjuvenile justicedigital health

Outcome Measures

Primary Outcomes (10)

  • Interpersonal Mindfulness in Parenting Scale (Mindful Parenting)

    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 months post baseline

  • Interpersonal Mindfulness in Parenting Scale (Mindful Parenting)

    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.

    6 months post baseline

  • Stress Index for Parents of Adolescents (Parenting Stress)

    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.

    3 months post baseline

  • Stress Index for Parents of Adolescents (Parenting Stress)

    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.

    6 months post baseline

  • Parenting Self-Efficacy

    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.

    3 months post baseline

  • Parenting Self-Efficacy

    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 months post baseline

  • Child and Adolescent Services Assessment (Barriers to Youth Treatment)

    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).

    3 months post baseline

  • Child and Adolescent Services Assessment (Barriers to Youth Treatment)

    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).

    6 months post baseline

  • Motivation for Youth Treatment

    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.

    3 months post baseline

  • Motivation for Youth Treatment

    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.

    6 months post baseline

Secondary Outcomes (2)

  • Youth Treatment Engagement

    3 months post baseline

  • Youth Treatment Engagement

    6 months post baseline

Other Outcomes (5)

  • Caregiver Mental Health & Substance Use

    3 months post baseline

  • Caregiver Mental Health & Substance Use

    6 months post baseline

  • mHealth Application Acceptability

    3 months post baseline

  • +2 more other outcomes

Study Arms (2)

mHealth parenting stress app

EXPERIMENTAL

mHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement.

Behavioral: mHealth parenting stress app

Standard of care

NO INTERVENTION

Caregiver participants will receive an informational brochure describing ways to support one's adolescent during detention and community reentry and any other usual care.

Interventions

mHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement.

mHealth parenting stress app

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • 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.
  • 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:
  • years or older
  • and speak fluent English.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, 94131, United States

RECRUITING

Related Publications (2)

  • Folk JB, McBride E, Nova S, Hurtado Y, Tolou-Shams M. Co-Design of the RAISE Mobile Health Intervention for and with Caregivers of Detained Youth. Res Child Adolesc Psychopathol. 2025 Dec;53(12):1813-1827. doi: 10.1007/s10802-025-01361-7. Epub 2025 Sep 22.

  • Folk JB, Aguilera A, Chaplin TM, Tolou-Shams M. Stress Management Among Caregivers of Detained Youth: Protocol for Randomized Controlled Trial of the RAISE Web-Based mHealth App. JMIR Res Protoc. 2025 Jul 10;14:e67511. doi: 10.2196/67511.

Study Officials

  • Johanna B Folk, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna B Folk, PhD

CONTACT

Alison Czopp, MSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 2, 2021

Study Start

September 15, 2021

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations