Emotion RegulationNCT05657067
Effectiveness and Feasibility of Structured EFFT
A study testing Emotionally Focused Family Therapy (EFFT) in people with Emotion Regulation, run by VU University of Amsterdam at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Emotionally Focused Family Therapy (EFFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jul 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Psychologiepraktijk Lenny Rodenbrug
Bussum, 1402BD
Lenny Rodenburg, MSc, 0031645663281, info@lennyrodenburg.nl
About this study
Official title: Effectiveness and Feasibility of Structured Emotionally Focused Family Therapy: A Pilot Study
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.
Read the detailed description
Background
The prevalence of mental health problems of children and adolescents worldwide is substantial with 10-20%. Attachment related emotion regulation is considered an important transdiagnostic process underlying mental health problems in adolescents. Emotionally Focused Family Therapy (EFFT) aims at the development of secure attachment between parents and their children in order to reduce the child's vulnerability for mental health problems and enhance resilience.
Intervention
The current pilot study is a first test of the newly developed protocol of structured EFFT. It consists of 4 phases and 16-21 sessions: phase 1 (1-2 sessions with the whole family) reframing the individual adolescent's problem as related to insecure attachment relations with the parents; phase 2A (4-6 sessions with the parents) and phase 2B (3 sessions with the adolescent) are delivered in parallel fashion and aim to prepare them to phase 3 by exploring insecure attachment relations and unfulfilled attachment needs; phase 3 (3 sessions with parents and adolescent) is focused on development of secure attachment relations between parents and adolescent; phase 4 (3 sessions with the whole family) consolidation of secure attachment and additional interventions for residual psychopathology; and finally a booster session with the whole family. Treatment adherence will be assessed with a check list by independent raters of sound recordings of random sessions.
Design and method
A within-subjects design, without randomized control group, with three waves will be applied: (1) waiting period of 2 months, (2) treatment phase 3-4 months, and (3) 2 months follow-up period concluded with a booster session. Comparing change during the waiting period vs. change during treatment will provide a clear indication of spontaneous remission vs. treatment-related change. The study will use a multi-method approach: quantitative for the effectiveness part (multilevel analyses of questionnaires) and qualitative for the feasibility part (semi-structured interviews). Treatment adherence will be assessed with sound recording of random sessions.
Hypotheses
Concerning the effectiveness of structured EFFT the researchers anticipate that, if limited power of this pilot study yields significant differences, outcomes will show:
- no, or less change during the waiting period compared with the treatment phase;
- gain during the treatment phase;
- and substantial maintenance during follow-up. Hypotheses will be tested with multi-level analyses. Feasibility will be explored.
- Conditions
- Emotion Regulation
- Being tested
- Emotionally Focused Family Therapy (EFFT)
- Keywords
- Attachment, Adolescents, Family, Mental Health Problems, Emotionally Focused Family Therapy (EFFT)
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotionally Focused Family Therapy (EFFT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Emotionally Focused Family Therapy (EFFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Feasibility will be assessed by semi-structured interviews.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start26 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Utrecht University
- Responsible party
- Principal investigator, Henk Jan Conradi, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657067
- Sponsor's protocol ID
- 2022-CP-15102
- Other IDs
- 2022-CP-15102
- Status last verified
- Jun 2024
- First submitted
- 27 Nov 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data management The data will be saved under administration numbers to which each family member is linked and stored on the protected ICT environment of the University of Amsterdam. The data analysis will be performed at the University of Amsterdam. Personal data will be handled conform the General Data Protection Regulation.
Publications
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.
PubMed 37352284
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Feasibility of Structured Emotionally Focused Family Therapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT05657067
- Acronym / sponsor ID
- 2022-CP-15102
- Conditions
- Emotion Regulation
- Keywords
- Attachment, Adolescents, Family, Mental Health Problems, Emotionally Focused Family Therapy (EFFT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Utrecht University
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
The prevalence of mental health problems of children and adolescents worldwide is substantial with 10-20%. Attachment related emotion regulation is considered an important transdiagnostic process underlying mental health problems in adolescents. Emotionally Focused Family Therapy (EFFT) aims at the development of secure attachment between parents and their children in order to reduce the child's vulnerability for mental health problems and enhance resilience.
Intervention
The current pilot study is a first test of the newly developed protocol of structured EFFT. It consists of 4 phases and 16-21 sessions: phase 1 (1-2 sessions with the whole family) reframing the individual adolescent's problem as related to insecure attachment relations with the parents; phase 2A (4-6 sessions with the parents) and phase 2B (3 sessions with the adolescent) are delivered in parallel fashion and aim to prepare them to phase 3 by exploring insecure attachment relations and unfulfilled attachment needs; phase 3 (3 sessions with parents and adolescent) is focused on development of secure attachment relations between parents and adolescent; phase 4 (3 sessions with the whole family) consolidation of secure attachment and additional interventions for residual psychopathology; and finally a booster session with the whole family. Treatment adherence will be assessed with a check list by independent raters of sound recordings of random sessions.
Design and method
A within-subjects design, without randomized control group, with three waves will be applied: (1) waiting period of 2 months, (2) treatment phase 3-4 months, and (3) 2 months follow-up period concluded with a booster session. Comparing change during the waiting period vs. change during treatment will provide a clear indication of spontaneous remission vs. treatment-related change. The study will use a multi-method approach: quantitative for the effectiveness part (multilevel analyses of questionnaires) and qualitative for the feasibility part (semi-structured interviews). Treatment adherence will be assessed with sound recording of random sessions.
Hypotheses
Concerning the effectiveness of structured EFFT the researchers anticipate that, if limited power of this pilot study yields significant differences, outcomes will show:
- no, or less change during the waiting period compared with the treatment phase;
- gain during the treatment phase;
- and substantial maintenance during follow-up. Hypotheses will be tested with multi-level analyses. Feasibility will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emotionally Focused Family Therapy (EFFT) | Experimental | Behavioral: Emotionally Focused Family Therapy (EFFT)For this pilot study we aim for 15-20 included families who will be treated by three to five family therapists. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotionally Focused Family Therapy (EFFT)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. | Behavioural | Emotionally Focused Family Therapy (EFFT) |
Primary outcome
Change from the waiting period in Negative interaction patterns on the Relationship Dynamics Scale (RDS; Stanley et al., 2001) during and after EFFT.
Time frame: 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)
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.
Change from the waiting period in Accessibility and responsiveness of the attachment figures on the Accessibility, Responsiveness, Emotional Engagement questionnaire (ARE; Johnson, 2008).
Time frame: 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)
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.
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).
Time frame: 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)
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.
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)
Time frame: 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)
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.
Change from the waiting period in Relationship satisfaction between the parents as partners on the Couple Satisfaction Index (CSI; Funk & Rogge, 2007).
Time frame: 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)
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.
Change from the waiting period in the adolescent's Complaints on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).
Time frame: 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)
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.
1 secondary outcome
Feasibility of structured EFFT.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 37352284Conradi 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data management The data will be saved under administration numbers to which each family member is linked and stored on the protected ICT environment of the University of Amsterdam. The data analysis will be performed at the University of Amsterdam. Personal data will be handled conform the General Data Protection Regulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotionally Focused Family Therapy (EFFT) in people with Emotion Regulation, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henk Jan Conradi, PhD (+31(0)205258606, h.j.conradi@uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the waiting period in Negative interaction patterns on the Relationship Dynamics Scale (RDS; Stanley et al., 2001) during and after EFFT. (time frame: 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.