Clinical trial NCT06966323: Hold me Tight/Let me Go: Effectiveness of a Course to Enhance Parent-adolescent Relationship
Official title: Hold me Tight/Let me Go: Effectiveness of a Course to Enhance Parent-adolescent Relationship
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parent Training
Parent Child Relationship
Parent-child Problem
Keywords: Hold Me Tight Program
Emotionally Focused Therapy
Parent Child Problems
Parent Child Relationships
Adolescents
Lead sponsor: University of Amsterdam
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: HOLD ME TIGHT/LET ME GO: STUDY PROTOCOL (version 2025-05-01) Participants In- and exclusion criteria will be determined with unstructured clinical interviews by experienced clinicians during the screening.

Inclusion criteria:

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.

Exclusion criteria:

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.

Design A randomized design comparing the intervention with a control group is not deemed feasible as this requires the simultaneous consent of families (i.e., father, mother and adolescent) to be randomized, which is much harder to achieve than with individuals. Further, the group format of the program (4 to 6 families) requires randomization of 8 to 12 families to be completed within a reasonable time frame otherwise families that were first randomized may drop out. From earlier experiences with randomization of groups of couples is known that this is not feasible because it will compromise inclusion unacceptably. Moreover, it was concluded that studies aiming at relationship enhancement may not need to include waitlist control groups as two meta-analyses found no statistically significant spontaneous improvement from relational problems (Baucom et al., 2003; Roddy et al., 2020). This is in contrast with depression which is known for its high spontaneous remission rates.

All in all, a within-subjects design will be used in which families serve as their own controls with three waves: waiting-period, treatment and follow-up. The waiting period will span on average five weeks (i.e., two to eight weeks), the treatment phase will last about 6 weeks, followed by a follow-up period of about 8 weeks). Change across the three waves will be compared. Little change is anticipated little change during the waiting period (indicating no spontaneous remission), gain during treatment, and little change (substantial maintenance) during follow-up.

Hypotheses:

1. ∆ waiting period \< ∆ intervention period
2. M post-intervention period ≈ M follow-up period To enable these comparisons all questionnaires must be administered at least four times (pre-waiting, pre-treatment, post-treatment, follow-up)

Procedure: intervention and assessments

The intervention is a course for groups of parents from 4-6 families to help them to enhance their relationship with their adolescent child. The procedure plus timeline for parents and adolescents will be:

1. Parents intake session (8 to 2 weeks prior to session 1, duration 45-60 min.) is part of the standard procedure of the participating clinical practice.

   Goal: determining whether parents and adolescent are eligible for the HmT/LmG program.

   Measurements: (a) parents: paper and pencil (14 min., see measurement scheme parents), and (b) adolescent: paper and pencil when coming along with the parents otherwise via Qualtrics (11 min., see measurement scheme adolescents).
2. Parents group session 1 (2 to 8 weeks after intake, duration 150 min.). Goal: parents receive psycho-education about: (a) basic adolescent's needs (safe bonding with parents, validation, and autonomy to discover their identity), (b) the importance of parents being open and helpful (the building blocks of secure attachment) to facilitate fulfillment of the adolescent's needs, and (c) recognition of negative parent-adolescent interaction patterns that thwart need fulfillment. Exercises and role play on recognition of negative patterns and their effects are included.

   Measurement: (a) parents: paper and pencil (14 min.), and (b) adolescent: Qualtrics (11 min.).
3. Parents group session 2 (1 week after session 1, duration: 150 min.). Goal: parents receive psycho-education about: (a) self-protective behavior modes that underlie the negative interaction pattern, (b) attachment underlying self-protective behavior, (c) how to de-escalate and validate their adolescent. Exercises and role play on validation are included.

   Measurement: (a) parents: paper \& pencil (5 min.).
4. Parents group session 3 (2 weeks after session 2, duration: 150 min.). Goal: parents receive psycho-education about: (a) stop escalation and start being open and helpful, (b) apologizing when the negative patterns re-emerges, ad (c) limit-setting to their adolescent. Exercises and role play on apologizing and limit setting are included.

   Measurements: (a) parents: paper \& pencil (6 min.).
5. Adolescent individual session (between group sessions 3 and 4, duration: 30-45 min.).

   Goal: adolescent interviewed by EFT therapist about: (a) negative patterns with the parents, and (b) unfulfilled needs.

   Measurement: (a) adolescent: live Qualtrics (8 min.). PhD student will take care of this.
6. Parents individual session (between group sessions 3 and 4, duration: 90 minutes).

   Goal: parents are prepared by an EFT therapist to a conversation with their adolescent aiming at restoring: (a) staying open and helpful, (b) help their adolescent to fulfil their needs, (c) without relapsing into the negative pattern.

   Measurement: parents: paper \& pencil (6.5 min.).
7. Parents-adolescent individual session (between sessions 3 and 4, duration: 90 min.).

   Goal: restoring the secure bond with parents and adolescents refraining from the negative pattern, and the adolescent is stimulated to be open about his/her unfulfilled needs, while the parents have to stay open \& helpful to the adolescents needs (i.e., repairing the secure bond by the three learned skills apologizing, validating and safe limit setting) Measurements: parents: paper \& pencil (6 min.), and (b) adolescent: paper \& pencil (7 min.), and EFT therapist: (c) audio recording of the session, and (d) scoring the degree of goal attainment for this sessions.
8. Parents group session 4 (3 weeks after session 3, duration: 150 min.). Goal: parents receive psycho-education about: (a) summary of the core content of the course. Exercises and role play on (aspects) of restoring the secure bond, and reading emotions and facilitation of needs of the adolescent.

   Measurements: (a) parents: paper \& pencil (12 min.), and (b) adolescent: Qualtrics (11 min.).
9. Parents-adolescent follow-up interview (8 weeks after session 4, duration 30-60 min.).

Goal: interview with parent(s) and adolescent about working mechanisms of HmT/LmG, testing a (initial) program theory (realist evaluation) to identify causal processes by examining how the program outcomes are caused by which underlying mechanisms within specific contexts.

Measurements: parents: live Qualtrics (12 min.), and (b) adolescent: live Qualtrics (11 min.), and (c) parents and adolescent: record of live qualitative interview via Zoom (30-60 min.).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in relationship satisfaction (CSI-4)
timeFrame: Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
measure: Change in negative patterns (RDS)
timeFrame: Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
Secondary outcomes:
measure: Adolescents psychological need fulfillment (BPNS-9)
timeFrame: Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
measure: Adolescents support seeking to parent (IERQ-3)
timeFrame: Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
measure: Adolescents quality of life (KIDSCREEN-10)
timeFrame: Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
measure: Perceived ARE from parent to adolescent (BARE-6)
timeFrame: Change from baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
Other outcomes:
measure: Attachment
timeFrame: baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
measure: Emotional clarity (understanding own emotions)
timeFrame: baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
measure: Validation of emotions
timeFrame: baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
measure: Apologizing and repair
timeFrame: baseline (pre-waiting, week 0) to post-intervention (week 5) and follow-up (week 13)
measure: Observation of secure base behavior
timeFrame: one-time measurement at parent-adolescent session (week 4)
Locations:
city: Almere
country: Netherlands
facility: Connected Together
city: Almere
country: Netherlands
facility: Molemann Mental Health
city: Bilthoven
country: Netherlands
facility: Twig Clinics B.V.
city: Hilversum
country: Netherlands
facility: Molemann Mental Health
city: Woerden
country: Netherlands
facility: Twig Clinics B.V.
Study officials:
affiliation: University of Amsterdam
name: Henk Jan Conradi, Doctor of Philosophy
role: PRINCIPAL_INVESTIGATOR
References: