Group Intervention to Improve Parent-Adolescent Relationships
NCT ID: NCT04780620
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-07-28
2023-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants will be parents or caregivers (for simplicity, the term "parent" is used to refer to parents or caregivers) of adolescents aged 13-18 with depression who are referred for outpatient services at a mental health research hospital in Toronto, Canada. Their adolescents will also participate in the study in order to provide multi-informant data; however, should adolescents decline to participate in the study, their parent will still be able to take part.
Parents will complete a combination of questionnaire and observationally coded measures at pre- and posttreatment, along with questionnaire measures at mid-treatment and 3 months follow-up. Adolescents will only complete questionnaire measures for all four time points.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Parent Intervention Group
The parent intervention group will undergo 8 weekly, manualized group sessions, with between 6 and 10 parent participants. Sessions are structured and follow an agenda including check-in and review of home practice, discussion of a skill or strategy, and review and assignment of home practice. Group sessions are held weekly for 1.5 hours and include both didactic, discussion, and practice elements, as well as assigned home practice.
Parent Intervention Group
Parents will be involved in 8 weekly sessions.
Usual Care Group
Parents in the usual care condition will be involved in their adolescent's care as is standard in our clinical program. With adolescent consent, parents are invited to participate in a single, 2-hour orientation session for parents/caregivers that provides information about depression, as well as the role of sleep, diet, and exercise in improving mood. Based on adolescent preference, parents can also attend regular psychiatric appointments with their adolescent, in which they will receive further information about depression and may receive and provide information about their adolescent's depression symptoms and response to psychosocial and pharmacological interventions. This control condition will allow us to determine whether the parent intervention is more effective than a relevant clinical alternative.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Parent Intervention Group
Parents will be involved in 8 weekly sessions.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* the adolescent is referred for outpatient services at CAMH
* adolescent has significant depressive symptoms, having either: a) a self-reported score of 23 or higher on the Mood and Feelings Questionnaire; or b) a depression diagnosis based on the Kiddie-Schedule for Affective Disorders and Schizophrenia from the last 3 months
* parent or youth endorse problematic levels of conflict in their relationship, having either: a) a total score of 9 or greater on the adolescent version, or a total score of 11 or greater on the parent version, of the 20-item Conflict Behavior Questionnaire; or b) a rating of 2 or higher on item 2 or 3 (Item 2 "getting along with your mother/mother figure;" item 3 "getting along with your father/father figure") of the youth-report version of the Columbia Impairment Scale
* both parent and adolescent speak, read, and write English at a Grade 6 level or above
Exclusion Criteria
* the adolescent has been diagnosed with bipolar disorder (I or II), schizophrenia, moderate-severe eating disorder, moderate-severe substance use disorder, or an intellectual disability (as the clinical and family needs of these adolescents are not likely to be sufficiently addressed by a general group for parents of adolescents with depression), or requires immediate hospitalization for suicide risk
* the parent/caregiver does not consent to participate
* (specific only to the virtual format of the study) the parent is not comfortable communicating via email or using WebEx for virtual appointments (as the use of WebEx and email is required for study visits and for participation in the parent intervention)
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre for Addiction and Mental Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Madison Aitken
Clinician Investigator at Cundill Centre for Child and Youth Depression; Psychologist in the Child, Youth and Emerging Adult Program
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Madison Aitken, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Madison Aitken, Ph.D.
Role: primary
Yola El Dahr, M.Sc.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
098-2020
Identifier Type: -
Identifier Source: org_study_id