NCT06966323

Brief Summary

HmT/LmG is a group course for 4-6 parental dyads and consists of 4 group sessions with psycho-education and skills training and 3 individual sessions per family (i.e., 1 session with the adolescent, 1 session with the parents, and 1 session with parents and adolescent together). We want to evaluate effectiveness and treatment process mechanisms applying self-reports, audio observation and interviews.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
28mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Jun 2025Sep 2028

First Submitted

Initial submission to the registry

May 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 11, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

May 2, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

Hold Me Tight ProgramEmotionally Focused TherapyParent Child ProblemsParent Child RelationshipsAdolescents

Outcome Measures

Primary Outcomes (2)

  • Change in relationship satisfaction (CSI-4)

    Positive change in relationship satisfaction of partners and adolescents (partners will report about their partner relationship, and parents and adolescents report about the parent-adolescent relationship). Satisfaction with the partner relationship of the parents, and the parent-adolescent relationship will be assessed with the 4 item Couple Satisfaction Index (CSI-4; Funk \& Rogge, 2007). Funk, J. L., \& Rogge, R. D. (2007). Testing the ruler with item response theory: Increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. Journal of Family Psychology, 21(4), 572-583. https://doi.org/10.1037/0893-3200.21.4.572

    Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)

  • Change in negative patterns (RDS)

    Negative change in negative patterns of partners and parents (partners will report about their partner relationship and parents and adolescents report about the parent-adolescent relationship). Negative patterns between the parents as partners and between parents and adolescent will be measured by the Relationship Dynamics Scale (RDS; Stanley et al., 2006) a four item self-report questionnaire. An example item is: 'When we argue, one of us withdraws, that is, does not want to talk about it anymore or leaves the scene.' Stanley, S. M., Amato, P. R., Johnson, C. A., \& Markman, H. J. (2006). Premarital education, marital quality, and marital stability: Findings from a large, random household survey. Journal of Family Psychology, 20(1), 117-126. https://doi.org/10.1037/0893-3200.20.1.117

    Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)

Secondary Outcomes (4)

  • Adolescents psychological need fulfillment (BPNS-9)

    Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)

  • Adolescents support seeking to parent (IERQ-3)

    Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)

  • Adolescents quality of life (KIDSCREEN-10)

    Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)

  • Perceived ARE from parent to adolescent (BARE-6)

    Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)

Other Outcomes (5)

  • Attachment

    baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)

  • Emotional clarity (understanding own emotions)

    baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)

  • Validation of emotions

    baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)

  • +2 more other outcomes

Interventions

Hold Me Tight / Let Me Go (HmT/LmG) is a manualized, group-based behavioral intervention for parents of adolescents aged 12 to 18. Grounded in Emotionally Focused Therapy (EFT) and Hold me Tight for couples. HmT/LmG aims to improve the parent-adolescent relationship by enhancing emotional validation, secure attachment, and effective communication. The intervention consists of four group sessions for parents, supplemented by three structured individual or dyadic sessions involving both parents and adolescents. Key components include psycho-education, role plays, emotion-focused conversations, and exercises targeting validation, apologizing, and supportive limit setting. Families complete pre- and post-intervention questionnaires and a follow-up assessment to evaluate changes in relationship quality and psychological well-being.

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Families with adolescents aged 12 to 18 years will be recruited via participating clinical practices (mental health organizations) in the Netherlands. Recruitment will focus on families experiencing difficulties in the parent-adolescent relationship that are believed to contribute to the adolescent's emotional or behavioral problems. The population includes single-parent families, two-parent families, and blended families. The intervention is offered in the context of regular care.

We will include: 1. Families with one or both parents/primary caretaker (single parent or blended families are allowed) with one adolescent of 12 to 18 years of age; 2. Adolescent problems are deemed to be exacerbated by a stressful parent-adolescent relationship. We will exclude: 1. Participants in command of the Dutch language. 2. Parents/primary caretakers and adolescents with severe psychopathology (e.g., psychosis, acute suicidality, severe depression) that will interfere with participation in the program. 3. Parents/primary caretakers already attending systemic therapy or intensive parental guidance during the waiting period and during HmT/LmG. Other individual therapy will be registered during intake, and afterwards by the therapists. During follow-up systemic interventions are allowed but have to be registered.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Connected Together

Almere Stad, Netherlands

ACTIVE NOT RECRUITING

Molemann Mental Health

Almere Stad, Netherlands

ACTIVE NOT RECRUITING

Twig Clinics B.V.

Bilthoven, Netherlands

RECRUITING

Molemann Mental Health

Hilversum, Netherlands

RECRUITING

Twig Clinics B.V.

Woerden, Netherlands

RECRUITING

Study Officials

  • Henk Jan Conradi, Doctor of Philosophy

    University of Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Jonker, Master of Science

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Psychology

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 11, 2025

Study Start

June 11, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Currently decided that individual participant data (IPD) will not be shared due to the sensitive nature of the data, which involves minors and families in a clinical setting. Ensuring participant confidentiality is a priority, and current infrastructure does not support secure sharing of these data. Future data sharing may be considered if appropriate anonymization and data use agreements can be established.

Locations