Group Intervention to Improve Parent-Adolescent Relationships

NCT04780620 | Unknown

• 1 other identifier: 098-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility Outcomes

  Feasibility defined as: * Participant recruitment rates, retention in the study, and completion of measures across time points * Parent satisfaction with the intervention * Parent attendance at the group and dropout from the group * Clinician fidelity to the intervention

  2 years (study duration)

Secondary Outcomes (4)

• Parent Expressed Emotion

  Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up

• Parent Affective Responding

  Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up

• Parent-Adolescent Conflict

  Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up

• Adolescent depression

  Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up

Study Arms (2)

Parent Intervention Group

EXPERIMENTAL

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.

Other: Parent Intervention Group

Usual Care Group

NO INTERVENTION

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 OTHER

Parents will be involved in 8 weekly sessions.

Parent Intervention Group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Madison Aitken, Ph.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison Aitken, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research personnel involved in data collection will be blind to participants' treatment condition (single blind). In addition, coders for the interaction task and speech sample will be blind to treatment condition (intervention versus control) and measurement time point (baseline vs. posttreatment).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator at Cundill Centre for Child and Youth Depression; Psychologist in the Child, Youth and Emerging Adult Program

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: July 28, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)