The goal of this feasibility randomized controlled pilot trial is to learn whether the trial can be done as planned, and to investigate if the 10-session parenting program "ATTACH(TM) increases mentalizing skills (the ability to reflect on thoughts and feelings) in parents of children between 0-5 years of age, who are receiving support for psychosocial problems in their municipal family treatment center.
The main questions the trial aims to answer are:
* How many eligible parents agree to participate in the random allocation to treatment? * How many parents allocated to receive "ATTACH(TM) will have completed the program 5 months after allocation (at least 7 out of 10 sessions)? * How many parents complete the data collection 5 months after allocation on the primary exploratory clinical outcome, i.e., parental mentalizing skills? * Do parents who received the ATTACH(TM) program show more increase in their mentalizing skills, compared to parents, who did not receive treatment with ATTACH(TM)?
Researchers will compare ATTACH, added to Treatment as Usual, with Treatment as Usual without ATTACH in three municipal family treatment centers located in the Capital Region of Denmark.
Participants will:
1. Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills. 2. Be randomly allocated to receive treatment in their local family center with or without ATTACH. 3. Take part in data collection 5 months after being allocated to either group, as well as participate in an interview about their experiences with the treatment they received. 4. After one year, the research group will follow up on the current treatment/support needs of the families, who were allocated to either group.
Child aged 0 - 5.7 years at enrollment.
Speaks Danish or English sufficiently to take part in assessments and intervention without an interpreter.
Both parents provide consent in case of shared child custody. Parents experience psycho-social problems that have resulted in referral to the family treatment center on the basis of legislation from the Danish Child Act ("Barnets Lov"), under the following Sections defining support needs: Section 29: Family counselling: Includes open access to family counselling as an early preventive effort. In this context, the counselling may involve referring the family to other departments within the municipality or to other relevant authorities that can provide the appropriate guidance and support. Section 30: Early preventive intervention: Includes a variety of approaches, such as consultancy services and participation in network or discussion groups to address and prevent challenges faced by the family at an early stage. Section 32: Supportive interventions: May be initiated on the basis of a preliminary assessment or a child welfare investigation pursuant to Sections 19 and 20 of the Child Act, or concurrently with the completion of such an assessment or investigation. Support may include practical, pedagogical, or other types of support in the home; appointment of a permanent contact person for the entire family; family therapy or individual treatment for the child or young person; family placement involving residential care in a foster family, an approved child and youth residential facility, or a housing facility; supportive placement in a foster family or in an approved child and youth residential facility; other forms of assistance aimed at providing counseling, treatment, and practical and pedagogical support.
Parents who have their child in out-of-home placement /foster care (with or without consent).
Child is older than 5.7 years at enrollment.
Parent does not speak Danish or English sufficiently to take part in assessments and intervention without an interpreter.
Consent cannot be obtained from both parents in case of shared child custody.
The parent is known to move to a different municipality within 5 months from randomization.
Parallel
ATTACH
BehavioralATTACH(TM) is a manualized, 10-session, mentalizing/reflective functioning-based parenting program, with one 45-60-minute weekly session. It is conducted individually with one parent focusing on one child throughout the program; however, a co-parent/parental support person will participate in session 7 and session 9. A session includes three components to facilitate parental reflective functioning: 1)Video-review of parent-child interaction, 2) reflection on a hypothetical situation (pre-defined for each session), and 3) reflection on a mildly stressful situation from the parent's everyday life with the child. The parent's reflective process is supported by handouts, e.g., "emotion cards". All material used in the sessions have been translated into Danish, and the wording have been modified to fit with the cultural context, based on feedback from two pilot studies. ATTACH is facilitated by professionals employed at the family centers, who have been trained and certified in ATTACH.
Treatment as Usual (TAU)
BehavioralTreatment As Usual (TAU) consists of the standard services and support typically offered to families by the local social- and healthcare systems within each municipality. These services vary depending on individual needs, risk assessment of the family, and municipal practices, but often include individual and/or group-based parenting support or therapeutic services at the trial site and/or in the parent's home. TAU may also involve referrals to additional resources or interventions deemed necessary by social authorities or healthcare providers (e.g., psychiatric treatment in the region). The control group will not receive the ATTACH™ program but will have access to all relevant standard care options available within their municipality. TAU can be delivered by different professionals, such as health visitors, social workers, family therapists/counsellors or clinical psychologists. For more details on TAU services at each trial site, see the attached project protocol.
Feasibility outcomes
As this is a feasibility trial, the primary aim is to assess feasibility rather than efficacy. We have therefore pre-defined three criteria that will guide our evaluation of whether a future large-scale trial is feasible: 1. Inclusion proportion: At least 25% of eligible parents consent to participation and randomization. 2. Compliance proportion: At least 50% of parents randomized to the ATTACH group complete ≥7 of 10 sessions. 3. Completion proportion: At least 70% of randomized participants provide complete data on the primary clinical exploratory outcome at 5 months.
Primary clinical exploratory outcome - parental mentalizing/insightfulness
Parents are assessed for their mentalizing capacity using the Parental Insightfulness Assessment interview (IA). Parental insightfulness is defined as the capacity to see things from the child's point of view. The IA is conducted as follows: 1) Video recordings of parent and child interacting. 2) Reviewing 2x2 minute video segments with the parent while conducting the interview. 3) transcription and coding of interview. The interview procedure has been modified to be in accordance with the trial's videorecording procedures, which originally includes reviewing of three video segments, while for this trial, we will include two video segments. The IA consists of 10 different scales, each given a score on a 9-point scale (low to high). Based on the scale scores, the parent is classified into one of four categories: Positively Insightful; One-sided; Disengaged; or Mixed. However, for this study, we will use scale scores from 1 to 9 as the primary indication of parental mentalizing capacity
Parental Reflective Functioning
Parental reflective functioning will be assessed using the Parental Reflective Functioning Questionnaire (PRFQ) for parents of children from 1 to 5 years, while the infant version (PRFQ-I) is used for children aged 0-1 year. The PRFQ/I is a self-report questionnaire consisting of 18 and 15 items, respectively. Item are scored on a 7-point Likert scale, ranging from 1 (completely disagree) to 7 (completely agree). Each item corresponds to one of three subscales reflecting aspects of parental reflective functioning, i.e., Interest and Curiosity in the child's thoughts and feelings; Certainty about the child's mental states; and pre-mentalizing (a non-mentalizing stance). The PRFQ/I is included in an online survey.
Reflective functioning, general
To assess non-parenting specific reflective functioning, we will use the 8-item version of the Reflective Functioning Questionnaire (RFQ-8). Each item of the RFQ-8 is scored on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The RFQ-8 is included in an online survey
Parental Mind-Mindedness
Mind-Mindedness (MM) reflects the parent's tendency to treat the child as a psychological individual in term of how they describe their child from a mentalizing stance, i.e., the child's thoughts, feelings, intentions etc. We will use the representational measure of MM, using parental written descriptions of their child: In the beginning of the online survey, the parent is probed to "describe your child", which will be coded according to the standard procedures. The MM is included in an online survey
Parent-child interaction quality, free-play
At the home-visit, a trial investigator instructs the parent to play with their child as they normally would for a total duration of seven minutes. If the child is seven months or older, the interaction includes a mild frustration episode after three minutes, lasting for one minute (parent is instructed to remove child's preferred toy and keep it away from child for one minute). This will be assessed using the method Coding Interactive Behavior, assessing mainly parental sensitivity. The CIB consist of 33 items, 18 related to parental behavior (e.g., acknowledging child signals); eight to the child's behavior (e.g., initiation), and five to the dyad (e.g., dyadic reciprocity), and, finally, two scales are on the lead-lag of the interaction (i.e., child- or parent-led). All items are rated on a scale ranging from 1 (representing the minimal level of the behavior) to 5 (representing the highest level), with the possibility of providing half points.
Support needs of family one year after randomization
One year after randomization, we will retrieve information from the family treatment units on the current support needs of the family. This is to assess whether the family has required additional or ongoing support, or whether their need for support has changed.
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Johanne Smith-Nielsen
Lead sponsor
University of Copenhagen
Sponsor institution
University of Calgary
Collaborator
