Recruiting

Observational Study

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT04780620

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

Parent Intervention Group

Study Details

Brief summary:

This pilot randomized control trial investigates whether a psychosocial intervention targeting parent-adolescent conflict is feasible and acceptable, in preparation for a future trial that will test whether the intervention can improve treatment outcomes for youth diagnosed with depression.

Conditions

Depression

Study ID

NCT04780620

Start date

Jul 28, 2021

Status verified date

Dec, 2022

Completion date

Aug, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • parent/caregiver of an adolescent aged 13-18 years
  • 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's primary diagnosis is not depression, based on information in their health record
  • 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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

Parent Intervention Group

Parents will be involved in 8 weekly sessions.

Primary outcome measure

  • Feasibility Outcomes [ Time Frame: 2 years (study duration) ]

Central Contacts and Locations

Central contacts

Madison Aitken, Ph.D.

416-535-8501madison.aitken@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Madison Aitken, Ph.D.

416-535-8501madison.aitken@camh.ca

Yola El Dahr, M.Sc.

yola.eldahr@camh.ca

Principal Investigator:

Madison Aitken, Ph.D.

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Dec 9, 2022

Last verified

Dec, 2022

Keywords

  • youth depression
  • adolescent depression
  • psychosocial intervention
  • parent-adolescent conflict

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2022-12-09.