Clinical trial NCT05353751: Kind Minds Program for Youth With Anxiety and Depression
Official title: Examining the Effectiveness of a Mindfulness-based Intervention for Underserved Adolescents With and Without Caregiver Involvement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Anxiety
Depression
Keywords: mindfulness
children
adolescents
anxiety
depression
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective interventions. Participation in mindfulness interventions has been demonstrated to reduce anxiety and depressive symptoms among teenagers. Parents' participation in mindfulness interventions has also been shown to reduce their children's mental health symptoms. However, there is no available evidence regarding potential additional benefits for adolescents' mental health of having both the adolescent and their parent or caregiver learn and practice mindfulness simultaneously.

This pilot intervention study aims to explore potential additive effects of parent/caregiver participation in a digitally-based, kindness-focused, coached mindfulness intervention program for adolescents that lasts 9 weeks. Participating parent/caregiver-child pairs (n = 30) will include one teenager between 12 and 17 years old with a current diagnosis of an anxiety or depressive disorder and one parent/caregiver. All adolescent participants will take part in the mindfulness intervention. Half of the parents/caregivers will be randomized to also take part in the mindfulness program. Outcomes will be compared between families in which only the teen participates in the mindfulness program and families in which the teen and parent/caregiver participate in the intervention.

Adolescents and parents/caregivers will take part in evaluations before, in the middle of, and after the end of the mindfulness program, meaning that participation in the study will take a total of approximately 12 weeks. Pre, mid, and post evaluations will include online questionnaires. Pre and post evaluations will also include clinical interviews via phone or video conference. Evaluations will include measures of mental health diagnoses and symptoms, mood, interpersonal and family functioning, mindfulness, and perceptions of/satisfaction with the program. Participating adolescents and parents/caregivers will also fill out weekly brief questionnaires of anxiety and depressive symptoms. The primary outcome of interest is adolescent mental health, including anxiety and depressive symptoms.


Eligibility criteria: Inclusion Criteria:

* Participants will include:

  1. one adolescent (aged 12-17 years) with a current diagnosis of an anxiety or depressive disorder)
  2. one of their parents/caregivers.
  3. Both adolescent and caregiver must speak English to the degree necessary to participate in the intervention program, which is only available in English.
  4. Parent and youth must have a smart phone and be willing to download the online mindfulness program.

Exclusion Criteria:

* Exclusion criteria apply to both caregiver and adolescent and include:

  1. current alcohol or substance use disorder or suicidality
  2. lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay diagnosed by an independent evaluator;
  3. English reading level below 4th grade
  4. non English speaking
  5. currently receiving mindfulness-based mental health services or taking medication to treat anxiety or depression.

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: 12-14 weeks after baseline assessment
measure: Generalized Anxiety Disorder-7
timeFrame: 12-14 weeks after baseline assessment
measure: SCARED -Screen for child anxiety and related emotional disorders
timeFrame: 12-14 weeks after baseline assessment
Secondary outcomes:
measure: Kiddie Schedule for Affective Disorders and Schizophrenia interview -anxiety and depressive disorder modules
timeFrame: 12-14 weeks after baseline assessment
Other outcomes:
Locations:
city: Imperial
country: United States
facility: Imperial High School
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Denise A Chavira, PhD
role: PRINCIPAL_INVESTIGATOR
References: