Clinical trial NCT05603000: Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties
Official title: A Randomized Controlled Trial of Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Behavior Problem
Keywords: children
parents
mental health
emotion
psychotherapy
parent-child relationship
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled trial, consisting of an intervention arm (EFFT) and a waitlist control (delayed intervention) arm, which will occur concurrently.
Primary purpose: TREATMENT

Brief summary: Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly.

This randomized controlled trial (RCT; EFFT vs waitlist control) will (1) test the efficacy of a 6-week group EFFT program on parent and child outcomes and (2) examine maintenance of treatment gains up to four months post-intervention.

Detailed description: This randomized controlled trial (RCT) will test the efficacy of a 6-week Emotion Focused Family Therapy (EFFT) group program on parent and child outcomes, compared to a waitlist control. Families will be randomized to either the EFFT group treatment or a waitlist. The RCT will evaluate changes in parent functioning, child functioning, and parent-child relationship functioning. A 4-month follow-up will test whether any changes from pre-to-post intervention are maintained at 4 months.

The RCT will also test proposed mechanisms of change (parent-child relationship quality, family functioning) and moderators of treatment effectiveness (parental stress).

Eligibility criteria: Inclusion Criteria:

* Parent of child aged 7 to 15 years old with anxiety, depression, or behavioural challenges
* Parent of child is willing to participate in intervention
* Parent is living at home with the child

Exclusion Criteria:

* Parent or child not proficient enough in speaking/understanding English to complete measures or EFFT intervention components
* Parent or child with a severe mental health disorder (e.g., active suicidality and psychosis) is not considered suitable for the trial intervention due to the clinical need for immediate intervention
* Parent or child is actively receiving, or due to receive, intensive psychological intervention focused on cognitive and/or behavioural strategies to intervene with emotional or behavioural difficulties
* Parent or child has any disabilities in language, speech or hearing that would interfere with their completion of the EFFT and measures
* Parent or child are allergic to adhesive electrode gel use in some tasks (i.e., sodium chloride)

Primary outcomes:
measure: Change in parental psychopathology symptoms at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Change in child psychopathology symptoms at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Change in parental emotion regulation at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Change in child emotion regulation at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Change in parent-child co-regulation at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Change in parent-child relationship functioning at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
Secondary outcomes:
measure: Change in parental emotion socialization at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Change in parental emotion blocks at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Change in parental self-efficacy at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Fidelity of EFFT program
timeFrame: Throughout intervention over 6 weeks
measure: Change in perceived parental stress at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Parental treatment satisfaction
timeFrame: At 6 weeks
measure: Parent-reported change in familial functioning at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
measure: Change in physiological arousal at 6 weeks and 4 months
timeFrame: Change at 6 weeks; Change at 4 months
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Maplewoods Centre for Family Therapy and Child Psychology, University of Guelph
state: Ontario
Study officials:
affiliation: University of Guelph
name: Kristel Thomassin, Ph.D
role: PRINCIPAL_INVESTIGATOR
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