Attachment and Child Health (ATTACH) Added to Treatment As Usual Versus Treatment As Usual Alone for Parents With Psychosocial Problems: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- Feasibility outcomes
研究概览
简要总结
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:
- Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills.
- Be randomly allocated to receive treatment in their local family center with or without ATTACH.
- 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.
- After one year, the research group will follow up on the current treatment/support needs of the families, who were allocated to either group.
详细描述
See the attached project protocol for a detailed description
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •Parental psychosocial problems such as (but are not limited to) mental health problems, cognitive difficulties, substance abuse, poverty, social isolation, adverse childhood experiences, functional or somatic disorders, criminal involvement, domestic violence, having a child with emotional regulation difficulties, having a child with developmental problems, having a child with functional or somatic problems, having a child with internalizing or externalizing problems.
排除标准
- •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.
结局指标
主要结局
Feasibility outcomes
时间窗: We will assess the proportion of three criteria at 5 months after randomization in both arms.
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
时间窗: IA is assessed at baseline prior to randomization and again at 5 months post randomization.
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
次要结局
- Parental Reflective Functioning(Assessed at baseline prior to randomization and at 5 months post randomization)
- Reflective functioning, general(Assessed at baseline prior to randomization and at 5 months post randomization)
- Parental Mind-Mindedness(Assessed at baseline prior to randomization and at 5 months post randomization)
- Parent-child interaction quality, free-play(Assessed at baseline prior to randomization and at 5 months post randomization)
- Parent-child interaction quality, teaching situation(Assessed at baseline prior to randomization and at 5 months post randomization)
- Child development(Assessed at baseline prior to randomization and again at 5 months post randomization)
- Child externalizing and internalizing problems and wellbeing(Assessed at baseline prior to randomization and at 5 months post randomization)
- Parental depression(Assessed at baseline prior to randomization and at 5 months post randomization)
- Parenting stress(Assessed at baseline prior to randomization and at 5 months post randomization)
- Resilience and coping with stress(Assessed at baseline prior to randomization and at 5 months post randomization)
- Family functioning(Assessed at baseline prior to randomization and at 5 months post randomization)
研究者
Johanne Smith-Nielsen
Associate Professor
University of Copenhagen