Effectiveness and Feasibility of Structured EFFT

NCT05657067 | Recruiting

• 1 other identifier: 2022-CP-15102
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical pilot study is to assess effectiveness and feasilibity of structured Emotionally Focused Family Therapy (EFFT) for parents and adolescents. Participants will fill out questionnaires before, during and after the EFFT treatment Finally, feasibility will be assessed by semi-structured interviews.

Conditions

Emotion Regulation

Keywords

Attachment; Adolescents; Family; Mental Health Problems; Emotionally Focused Family Therapy (EFFT)

Outcome Measures

Primary Outcomes (6)

• Change from the waiting period in Negative interaction patterns on the Relationship Dynamics Scale (RDS; Stanley et al., 2001) during and after EFFT.

  The RDS is a validated self-reported 4 item questionnaire assessing negative interaction patterns over the past 2 weeks. Possible total scores range from 4 (negligible) to 16 (often). Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.

  Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)

• Change from the waiting period in Accessibility and responsiveness of the attachment figures on the Accessibility, Responsiveness, Emotional Engagement questionnaire (ARE; Johnson, 2008).

  The ARE is a validated self-reported 6 item questionnaire assessing accessibility and responsiveness of the attachment figures over the past month. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.

  Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)

• Change from the waiting period in Discipline on the Discipline subscale of the Self-Efficacy for Parenting Tasks Index Toddler Scale (SEPTI; Coleman & Karraker, 2003).

  The Discipline 7 item subscale is part of the SEPTI a validated self-reported questionnaire assessing displine of the children by their partners over the past month. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.

  Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)

• Change from the waiting period in Attachment between parents and adolescent and the parents as partners on the Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS; Fraley et al., 2011)

  The ECR is a validated self-reported 9 item questionnaire assessing Anxiety about rejection and abandonment and Avoidance of intimacy. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.

  Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)

• Change from the waiting period in Relationship satisfaction between the parents as partners on the Couple Satisfaction Index (CSI; Funk & Rogge, 2007).

  The CSI is a validated self-reported 4 item questionnaire assessing relationship satisfaction over the past week. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.

  Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)

• Change from the waiting period in the adolescent's Complaints on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).

  The SDQ is a validated self-reported 20 item questionnaire assessing adolescent's Complaints over the past month. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.

  Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)

Secondary Outcomes (1)

• Feasibility of structured EFFT.

  Two months after the final session, after the booster session has taken place. Semi-structured interviews will take place with the adolescent being interviewed separately from his or her parents.

Study Arms (1)

Emotionally Focused Family Therapy (EFFT)

EXPERIMENTAL

For this pilot study we aim for 15-20 included families who will be treated by three to five family therapists.

Behavioral: Emotionally Focused Family Therapy (EFFT)

Interventions

Emotionally Focused Family Therapy (EFFT) BEHAVIORAL

The rationale behind EFFT is that mental health problems in children and adolescents often originate and/or are exacerbated by negative interaction patterns rooted in insecure attachment bonds within families. Therefore, the main treatment goal of EFFT is the development of secure attachment between parents and their children.

Emotionally Focused Family Therapy (EFFT)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For this pilot study we will include families with
• adolescents aged 12-18 years (the so called 'identified' patient), and
• families coping with mild problems.

You may not qualify if:

• The latter means that we will exclude:
• blended families because of the more complex loyalties that exist between children and stepparents,
• families of which individual members cope with serious trauma such as sexual and physical abuse and severe neglect, and
• families of which the parents or children are diagnosed with severe DSM disorders (substance abuse or psychosis).

Sponsors & Collaborators

• VU University of Amsterdam: lead
• Utrecht University: collaborator

Study Sites (1)

Psychologiepraktijk Lenny Rodenbrug

Bussum, 1402BD, Netherlands

RECRUITING

Related Publications (1)

• Conradi HJ, Meuwese D, Rodenburg L, Dingemanse P, Mooren T. Effectiveness and feasibility of structured emotionally focused family therapy for parents and adolescents: Protocol of a within-subjects pilot study. PLoS One. 2023 Jun 23;18(6):e0287472. doi: 10.1371/journal.pone.0287472. eCollection 2023.

  PMID: 37352284 DERIVED

Related Links

• This is the preregistration at the Open Science Framework which was published before recruitment commenced. The study protocol described at OSF is identical to the one provided here.

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Central Study Contacts

Henk Jan Conradi, PhD

CONTACT

+31(0)205258606; h.j.conradi@uva.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant Professor

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 20, 2022
• Study Start: July 26, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)