Group Intervention to Improve Parent-Adolescent Relationships
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|ClinicalTrials.gov Identifier: NCT04780620|
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Depression||Other: Parent Intervention Group||Not Applicable|
Parent involvement in psychosocial interventions for youth diagnosed with internalizing disorders has been cited as a contributor to better outcomes for these youth, and parent components have been included in several evidence-based interventions for adolescent mental health problems. Additionally, youth experiencing mood and behaviour changes that come about as a result of a depressive episode can lead to frustrated/overprotective reactions from parents, which can contribute to worse outcomes for these adolescents. Interventions focused on addressing parent-adolescent conflict and reducing negative interactions can potentially support recovery from depression and reduce episode relapse. However, there is very little research on including parent components in psychosocial interventions specifically aimed at youth depression. This randomized control trial aims to fill this gap by randomizing parents of youth receiving treatment for depression into either 1) an 8-week virtual or in-person group parent intervention, or 2) usual care.
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 part of the care pathway for youth depression 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 and adolescents will complete a combination of questionnaire, interview, and observationally coded measures at pre- and posttreatment, along with questionnaire measures at mid-treatment and 3 months follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||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).|
|Primary Purpose:||Supportive Care|
|Official Title:||Addressing Parent-Adolescent Relationship Issues in the Treatment of Adolescent Depression: A Pilot Study|
|Estimated Study Start Date :||March 2021|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
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.
Other: Parent Intervention Group
Parents will be involved in 8 weekly sessions.
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.
- Feasibility Outcomes [ Time Frame: 2 years (study duration) ]
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
- Parent Expressed Emotion [ Time Frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up ]Parent report on the Family Questionnaire; Adolescent report on the Level of Expressed Emotion questionnaire; Observational coding of parent Five Minute Speech Sample
- Parent Affective Responding [ Time Frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up ]Parent and adolescent report on the Coping with Children's Negative Emotions Scale and the Responding to Adolescents' Happy Affect Scale
- Parent-Adolescent Conflict [ Time Frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up ]Parent and adolescent report on the Issues Checklist
- Parent-Adolescent Interaction [ Time Frame: Pre- & post-treatment (8 weeks) ]Observational coding of parent-adolescent discussion of a topic of conflict (drawn from the Issues Checklist), coded using the System for Coding Interactions in Family Functioning
- Adolescent depression [ Time Frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up ]Adolescent self-report on the Mood and Feelings Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780620
|Contact: Madison Aitken, Ph.D.||416-535-8501 ext firstname.lastname@example.org|
|Principal Investigator:||Madison Aitken, Ph.D.||Centre for Addiction and Mental Health|