NCT05603000

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
10mo left

Started Oct 2022

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2022Mar 2027

Study Start

First participant enrolled

October 11, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 23, 2026

Status Verified

October 1, 2025

Enrollment Period

4.4 years

First QC Date

October 13, 2022

Last Update Submit

January 21, 2026

Conditions

Keywords

childrenparentsmental healthemotionpsychotherapyparent-child relationship

Outcome Measures

Primary Outcomes (6)

  • Change in parental psychopathology symptoms at 6 weeks and 4 months

    This outcome will be measured through the Kessler Psychological Distress Scale (K10), a 10-item self report measure of psychological symptoms that parents will complete. Parents will rate the extent to which they are affected by various psychopathology symptoms on a five-point Likert scale from 1 (None of the time) to 5 (All of the time), with greater total scores (range = 10-50) indicating more severe psychopathology.

    Change at 6 weeks; Change at 4 months

  • Change in child psychopathology symptoms at 6 weeks and 4 months

    This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by both parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem), with greater scores (Internalizing subscale range = 0-24; Externalizing subscale range = 0-24; Total score range = 0-48) indicating more severe psychopathology.

    Change at 6 weeks; Change at 4 months

  • Change in parental emotion regulation at 6 weeks and 4 months

    This outcome will be measured through the Difficulties in Emotion Regulation Scale (DERS), a 36-item self-report measure of emotion regulation difficulties to be completed by parents. Parents will indicate the frequency with which they experience difficulties with emotion regulation on a five-point Likert scale from 1 (Almost never) to 5 (Almost always), with greater total scores (range = 36-180) indicating greater difficulties with emotion regulation.

    Change at 6 weeks; Change at 4 months

  • Change in child emotion regulation at 6 weeks and 4 months

    This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report). Parents and children will rate the seven Negative Emotionality items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7-28) indicating poorer emotion regulation.

    Change at 6 weeks; Change at 4 months

  • Change in parent-child co-regulation at 6 weeks and 4 months

    This outcome will be measured by parent-child synchrony of heart rate variability during the completion of two lab tasks together (conflict discussion and puzzle task).

    Change at 6 weeks; Change at 4 months

  • Change in parent-child relationship functioning at 6 weeks and 4 months

    This outcome will be measured by having parents and their children participate in two lab tasks together (conflict discussion and puzzle task) and coding for behavioural observations.

    Change at 6 weeks; Change at 4 months

Secondary Outcomes (8)

  • Change in parental emotion socialization at 6 weeks and 4 months

    Change at 6 weeks; Change at 4 months

  • Change in parental emotion blocks at 6 weeks and 4 months

    Change at 6 weeks; Change at 4 months

  • Change in parental self-efficacy at 6 weeks and 4 months

    Change at 6 weeks; Change at 4 months

  • Fidelity of EFFT program

    Throughout intervention over 6 weeks

  • Change in perceived parental stress at 6 weeks and 4 months

    Change at 6 weeks; Change at 4 months

  • +3 more secondary outcomes

Study Arms (2)

Waitlist (delayed intervention)

NO INTERVENTION

No treatment will be administered to participants in this arm until after the 4-month follow-up in-lab assessment is completed.

EFFT intervention

EXPERIMENTAL

Treatment (6-week group Emotion Focused Family Therapy) will be administered to participants in this arm.

Behavioral: Emotion Focused Family Therapy

Interventions

The Emotion Focused Family Therapy (EFFT) intervention for this study will be delivered to groups of four to ten parents over six weekly sessions of two hours each. The goal of EFFT is to teach and empower parents to coach their child to process the emotions at the source of their mental health symptoms, to increase their child's adaptive behaviours, and to repair emotional injuries within the parent-child relationship. EFFT also targets parents' own emotional challenges that may prevent them from feeling capable or being able to support their child's treatment. Each EFFT session will include introductions, psychoeducation about emotion and psychopathology, introduction of skills, experiential activities (e.g., chair work), open discussion and feedback, and homework activities covering the foci of EFFT: emotion coaching, behaviour coaching, therapeutic apology, and parental emotion blocks.

Also known as: EFFT
EFFT intervention

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maplewoods Centre for Family Therapy and Child Psychology, University of Guelph

Guelph, Ontario, N1G 4S7, Canada

RECRUITING

Related Publications (30)

  • National Research Council (US) and Institute of Medicine (US) Committee on the Prevention of Mental Disorders and Substance Abuse Among Children, Youth, and Young Adults: Research Advances and Promising Interventions; O'Connell ME, Boat T, Warner KE, editors. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32775/

    PMID: 20662125BACKGROUND
  • Ogundele MO. Behavioural and emotional disorders in childhood: A brief overview for paediatricians. World J Clin Pediatr. 2018 Feb 8;7(1):9-26. doi: 10.5409/wjcp.v7.i1.9. eCollection 2018 Feb 8.

    PMID: 29456928BACKGROUND
  • Campbell SB, Shaw DS, Gilliom M. Early externalizing behavior problems: toddlers and preschoolers at risk for later maladjustment. Dev Psychopathol. 2000 Summer;12(3):467-88. doi: 10.1017/s0954579400003114.

    PMID: 11014748BACKGROUND
  • Freuchen A, Kjelsberg E, Lundervold AJ, Groholt B. Differences between children and adolescents who commit suicide and their peers: A psychological autopsy of suicide victims compared to accident victims and a community sample. Child Adolesc Psychiatry Ment Health. 2012 Jan 4;6:1. doi: 10.1186/1753-2000-6-1.

    PMID: 22216948BACKGROUND
  • Reef J, Diamantopoulou S, van Meurs I, Verhulst FC, van der Ende J. Developmental trajectories of child to adolescent externalizing behavior and adult DSM-IV disorder: results of a 24-year longitudinal study. Soc Psychiatry Psychiatr Epidemiol. 2011 Dec;46(12):1233-41. doi: 10.1007/s00127-010-0297-9. Epub 2010 Oct 10.

    PMID: 20936464BACKGROUND
  • Buckholdt KE, Parra GR, Jobe-Shields L. Intergenerational Transmission of Emotion Dysregulation Through Parental Invalidation of Emotions: Implications for Adolescent Internalizing and Externalizing Behaviors. J Child Fam Stud. 2014 Feb 1;23(2):324-332. doi: 10.1007/s10826-013-9768-4.

    PMID: 24855329BACKGROUND
  • Cao M, Powers A, Cross D, Bradley B, Jovanovic T. Maternal emotion dysregulation, parenting stress, and child physiological anxiety during dark-enhanced startle. Dev Psychobiol. 2017 Dec;59(8):1021-1030. doi: 10.1002/dev.21574. Epub 2017 Oct 13.

    PMID: 29027660BACKGROUND
  • Fabes RA, Leonard SA, Kupanoff K, Martin CL. Parental coping with children's negative emotions: relations with children's emotional and social responding. Child Dev. 2001 May-Jun;72(3):907-20. doi: 10.1111/1467-8624.00323.

    PMID: 11405590BACKGROUND
  • Morris AS, Silk JS, Steinberg L, Myers SS, Robinson LR. The Role of the Family Context in the Development of Emotion Regulation. Soc Dev. 2007 May 1;16(2):361-388. doi: 10.1111/j.1467-9507.2007.00389.x.

    PMID: 19756175BACKGROUND
  • Ramsden SR, Hubbard JA. Family expressiveness and parental emotion coaching: their role in children's emotion regulation and aggression. J Abnorm Child Psychol. 2002 Dec;30(6):657-67. doi: 10.1023/a:1020819915881.

    PMID: 12481978BACKGROUND
  • Granic I, O'Hara A, Pepler D, Lewis MD. A dynamic systems analysis of parent-child changes associated with successful "real-world" interventions for aggressive children. J Abnorm Child Psychol. 2007 Oct;35(5):845-57. doi: 10.1007/s10802-007-9133-4. Epub 2007 Jun 5.

    PMID: 17549621BACKGROUND
  • Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.

    PMID: 12214795BACKGROUND
  • Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.

    PMID: 30657721BACKGROUND
  • Lahey BB, Applegate B, Chronis AM, Jones HA, Williams SH, Loney J, Waldman ID. Psychometric characteristics of a measure of emotional dispositions developed to test a developmental propensity model of conduct disorder. J Clin Child Adolesc Psychol. 2008 Oct;37(4):794-807. doi: 10.1080/15374410802359635.

    PMID: 18991130BACKGROUND
  • Foroughe M, Stillar A, Goldstein L, Dolhanty J, Goodcase ET, Lafrance A. Brief Emotion Focused Family Therapy: An Intervention for Parents of Children and Adolescents with Mental Health Issues. J Marital Fam Ther. 2019 Jul;45(3):410-430. doi: 10.1111/jmft.12351. Epub 2018 Aug 13.

    PMID: 30105875BACKGROUND
  • Lafrance Robinson A, Dolhanty J, Stillar A, Henderson K, Mayman S. Emotion-Focused Family Therapy for Eating Disorders Across the Lifespan: A Pilot Study of a 2-Day Transdiagnostic Intervention for Parents. Clin Psychol Psychother. 2016 Jan-Feb;23(1):14-23. doi: 10.1002/cpp.1933. Epub 2014 Nov 23.

    PMID: 25418635BACKGROUND
  • Lafrance A, Strahan EJ, Stillar A. Treatment-engagement fears in family-oriented interventions: validation of the caregiver traps scale for eating disorders. Eat Disord. 2022 Nov-Dec;30(6):670-685. doi: 10.1080/10640266.2021.1993706. Epub 2021 Nov 7.

    PMID: 34743672BACKGROUND
  • Lafrance A, Henderson KA, Mayman S. Emotion-focused family therapy: A transdiagnostic model for caregiver-focused interventions. American Psychological Association; 2020.

    BACKGROUND
  • Vrana G, Greenberg L. Overview of emotion-focused therapy. In Emotion Focused Family Therapy with Children and Caregivers 2018 Mar 15 (pp. 1-22). Routledge.

    BACKGROUND
  • Strahan EJ, Stillar A, Files N, Nash P, Scarborough J, Connors L, Gusella J, Henderson K, Mayman S, Marchand P, Orr ES. Increasing parental self-efficacy with emotion-focused family therapy for eating disorders: A process model. Person-Centered & Experiential Psychotherapies. 2017 Jul 3;16(3):256-69.

    BACKGROUND
  • Wilhelmsen-Langeland A, Aardal H, Hjelmseth V, Fyhn KH, Stige SH. An emotion focused family therapy workshop for parents with children 6-12 years increased parental self-efficacy. Emotional and Behavioural Difficulties. 2020 Jan 2;25(1):29-41.

    BACKGROUND
  • Nash P, Renelli M, Stillar A, Streich B, Lafrance A. Long-term outcomes of a brief emotion-focused family therapy intervention for eating disorders across the lifespan: a mixed-methods study. Canadian Journal of Counselling and Psychotherapy. 2020 Apr 14;54(2):130-49.

    BACKGROUND
  • Bode AA, George MW, Weist MD, Stephan SH, Lever N, Youngstrom EA. The impact of parent empowerment in children's mental health services on parenting stress. Journal of Child and Family Studies. 2016 Oct;25(10):3044-55.

    BACKGROUND
  • Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment. 2004 Mar;26(1):41-54.

    BACKGROUND
  • Fabes RA, Poulin RE, Eisenberg N, Madden-Derdich DA. The Coping with Children's Negative Emotions Scale (CCNES): Psychometric properties and relations with children's emotional competence. Marriage & Family Review. 2002.

    BACKGROUND
  • Hamilton VE, Matthews JM, Crawford SB. Development and preliminary validation of a parenting self-regulation scale:"me as a parent". Journal of child and family studies. 2015 Oct;24(10):2853-64.

    BACKGROUND
  • Berry JO, Jones WH. The Parental Stress Scale: Initial psychometric evidence. Journal of Social and Personal Relationships. 1995; 12(3), 463-472.

    BACKGROUND
  • Hawley K, Weersing V, Weisz J. The parent and youth consumer satisfaction scales; unpublished questionnaire; 1998.

    BACKGROUND
  • Epstein NB, Baldwin LM, Bishop DS. The McMaster Family Assessment Device. Journal of Marital and Family Therapy. 1983; 9(2), 171-180.

    BACKGROUND
  • Seddon JA, Reaume CL, Thomassin K. A six-week group program of emotion focused family therapy for parents of children with mental health challenges: protocol for a randomized controlled trial. BMC Psychiatry. 2025 Feb 14;25(1):131. doi: 10.1186/s12888-024-06382-y.

MeSH Terms

Conditions

Anxiety DisordersDepressionMental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Kristel Thomassin, Ph.D

    University of Guelph

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristel Thomassin, Ph.D

CONTACT

Jessica A Seddon, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled trial, consisting of an intervention arm (EFFT) and a waitlist control (delayed intervention) arm, which will occur concurrently.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 13, 2022

First Posted

November 2, 2022

Study Start

October 11, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 23, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations