Effectiveness of Video-feedback to Promote Positive Parenting in Families with Children At Risk of Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Parental anxiety
研究概览
简要总结
Improving parent-child interactions benefits child development and parents' perception of their competencies for childrearing and support for child learning and development, which in turns positively impacts on parental emotional well-being and Family Qualiy of Life.
This intervention protocol aims to improve the quality of parent-child interactions in daily-routine activities (bath time, dressing, mails...), specially during play interactions at home, increasing the frequency and consistency of the 29 positive parental behaviors included in the PICCOLO. PICCOLO is an observational tool for assessing positive parental behaviors in caregiver-child interactions that have been positively related to child cognitive, socioemotional, and linguistic development. It was developed and published in the United States, and it was validated in Spain with mothers and fathers. An Spanish handbook has been also published.
Guiding principles of the intervention protocol are an emphasis on the parents' strengths; a focus on daily routines in family context; and a non-directive intervention style, based on video feedback and coaching strategies as self-appraisal and reflection.
Although the protocol could be applied to different populations, this study is implemented with mothers and fathers with a young child (aged 24-36 months) at risk of Autism Spectrum Disorder (ASD). All children and their families are being cared for by professionals in Early Intervention Centers in Spain. Inclusion criteria for receiving this intervention are a) child at medium-high risk of ASD; b) primary caregiver at risk of anxiety, depression, or parental stress; c) primary caregiver with a low or medium-low level of positive parental behaviors in the PICCOLO.
The protocol includes bimonthly sessions of 60 minutes duration for six months with the main caregiver who participates in the program. Sessions are conducted by videoconference. Every session focuses on three different PICCOLO behaviors that have been identified in a previously recorded caregiver-child interaction during play at home (book-reading, symbolic play, or manipulative play). A new video is auto recorded every month by parents, so that each video is analyzed together with the caregiver in two sessions. After each session, the parents receive a written reminder of the aspects that have been worked on in the video feedback session, and of the agreements regarding the situations of daily life in which these aspects could be put into practice.
Family picture-books are progressively created, including selected frames from the videotapes that illustrate the positive parental behaviors that have been discussed. Six new images are included every month. Caregivers are encouraged to look at and talk about the book with their children at home and to share it with other family members.
The primary aim of the proposed study is to assess the efficacy of an intervention to improve caregiver competencies through the observation of caregiver-child interaction, using video-feedback coaching strategies based on parental strengths, from a collaborative model.
It is hypothesized that (1) developmentally supportive parental behaviors of mothers and fathers, measured with PICCOLO, after the intervention will be significantly higher in the intervention group (IG) than in the control group (CG); (2) levels of anxiety, or depression and/or stress of mothers and fathers after intervention will be significantly lower in the IG than in the CG; (3) Parental self-efficacy of mothers and fathers after the intervention will be significantly higher in the IG than in the CG; and (4) family quality of life after intervention will be significantly higher in the IG than in the CG. Also, it is hypothesized that individual trajectories in families within the IG will show changes in the outcome variables consistent with these expectations during the intervention period. it is hypothesized that these positive changes will not be observed in the CG, who will continue receiving the usual early intervention services.
With respect to intervention assessment, it is hypothesized that there will be significant and positive associations between key outcomes of the study and the scores obtained on the HOVRS-3 measure of four evidence-based home visiting practices: relationship building with families, responsiveness to family strengths, facilitating family interaction, collaboration with caregivers.
Finally, it is expected to find a secondary benefit on child's development, assessed with the DP-3 (Developmental Profile-3), particularly in the communication and social adaptation areas.
详细描述
The main objective of the study is to analyze the efficacy of a video feedback intervention in a group of mothers and fathers with children at risk of autism spectrum disorders (ASD). The intervention's impact on four variables will be assessed: parenting (1), the emotional distress of mothers and fathers (anxiety, depression and stress) (2), parental self-efficacy (3) and family quality of life (4). The differential change in individual trajectories will be analyzed for the four variables, based on belonging to the experimental group. The aim is to develop an intervention guide for the use of coaching strategies based on observation and video feedback.
Participants in the study will be 60 families comprised of a main caregiver (mother or father) of a child at risk of ASD between 24 and 36 months of age, with adequate internet access, who will be recruited from early intervention centers in Spain. The inclusion criteria are: a) the children have M-Chat scores compatible with medium-high risk of ASD (scores equal to or greater than 8); b) the main caregiver has high scores in at least one of the following variables: b.1) anxiety quantified using the HADS scale (scores equal to or greater than 7); b.2) depression quantified using the HADS scale (scores equal to or greater than 7); b.3) stress measured using the stress dimension of the PSI-F tool (scores equal to or greater than 86); c) the main caregiver has low parenting scores, quantified by the total score on the PICCOLO, an observational tool to score parental behaviors that support child development (score equal to or less than 40). The exclusion criteria are that the family: a) is currently receiving or has received in the last 12 months an intervention to improve parental interactions similar to the one proposed in this project or protocol; b) does not have a good level of written and spoken Spanish; or c) has mental health problems or children with serious physical problems or multiple disabilities.
The 60 families that meet the inclusion criteria will be randomly distributed into two groups of 30 families (intervention group and control group).
All the participants, both in the intervention group and the control group, will answer the questionnaires on emotional distress (anxiety, depression and parental stress), parental self-efficacy and family quality of life before and after the intervention. Child development will be evaluated before and after the intervention with the DP-3 instrument. Families will make an audiovisual recording of 10 minutes of play interaction at home with their child, under the conditions to which we will refer later.
For all the cases in the intervention group, the same protocol will be followed, which combines coaching strategies based on observation and video feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A masking technique will be applied during the evaluation/recording phases of primary and secondary variables, as well as in the statistical analysis phase as described below. During the recording of variables, participants will only be identified by an alphanumeric label and without any reference to the group assigned at the beginning of the investigation. As regards data analysis, this will be carried out using anonymized databases and, automatically, a correspondence will be made between the participant's identifier and the group to which he/she has been assigned to carry out the appropriate statistical analyses.
入排标准
- 年龄范围
- 24 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate family internet access. Child aged between 24 and 36 months. Child with a M-CHAT-R score compatible with high risk of ASD according to the manual (Score equal to or greater than 8 points).
- •Main caregiver with a high score in at least one of the following variables: a) anxiety quantified using the Hospital Anxiety and Depression Scale (HADS) (score equal to or greater than 7 points); b) depression quantified using the HADS (score equal to or greater than 7 points); c) stress measured using the stress dimension of the Parenting Stress Scale Short Form (PSI-F) (score equal to or greater than 86 points).
- •Main caregiver with a low level of developmentally supportive parental behaviors, quantified by the total score on the Spanish version of the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) (score equal to or less than 40 points). 40 points correspond to the 16% of the lowest scores in the Spanish validation sample for mothers, at 36 months of child's age.
排除标准
- •The family is currently receiving or has received in the last twelve months an intervention to improve parental interactions like the one proposed in this protocol, using positive feedback guidance based on observation of parent-child interaction.
- •Caregiver without a level of written and spoken Spanish that allows the intervention to be carried out.
- •Caregiver without internet connection for videoconferences. Caregiver with diagnosed mental health problems, excluding anxiety or depression symptoms.
- •Child with serious physical disability or multiple disabilities.
结局指标
主要结局
Parental anxiety
时间窗: Pre-intervention, after six months of intervention, and follow-up six months later
The Spanish version of the Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety symptoms in children's caregivers. The HADS is a self-reporting screening questionnaire composed of 14 items (seven items concerning depression symptoms and seven for anxiety symptoms) scored on a Likert scale from 0 to 3 points. Scores higher than 7 points in the subscale of anxiety symptoms, would indicate a risk of suffering health problems due to the mental issue assessed.
Parental depression
时间窗: Pre-intervention, after six months of intervention, and follow-up six months later
The Spanish version of the Hospital Anxiety and Depression Scale (HADS) will be used to assess depression symptoms in children's caregivers. The HADS is a self-reporting screening questionnaire composed of 14 items (seven items concerning depression symptoms and seven for anxiety symptoms) scored on a Likert scale from 0 to 3 points. Scores higher than 7 points in the subscale of depression symptoms, would indicate a risk of suffering health problems due to the mental issue assessed.
Parental stress
时间窗: Pre-intervention, after six months of intervention, and follow-up six months later
The Spanish version of the Parental Stress Scale (PSS) will be used to assess how caregivers perceive parental situations as stressful. This tool is composed of 12 items scored on a Likert scale, from 1 (total disagreement) to 5 (full agreement). The higher the score obtained, the higher the level of parental stress. Scores greater than or equal to 86 points would indicate a clinically significant parental stress score.
Parental behaviors ( Affection, Responsiveness, Encouragement, Teaching)
时间窗: Pre-intervention, after six months of intervention, and follow-up six months later
The Spanish version of the PICCOLO (Parenting Interactions with Children: Checklist of Observations Linked to Outcomes) will be used to assess parental behaviors. It is a reliable and validated 29-item measure of parent-child interactions for parents with children aged between 10 and 47 months old. The items are scored according to their frequency as 0 (absent, not observed), 1 (rare, minor or emerging) and 2 (clear, definitive, strong and frequent). The items are grouped into four domains: (a) Affection (7 items), which involves the physical and verbal expression of affection; (b) Responsiveness (7 items), which includes reacting sensitively to a child's cues and expressions; (c) Encouragement (7 items), which considers the parents' support of their child's efforts; and (d) Teaching (8 items), which includes cognitive stimulation, joint attention, and shared play. This tool has a total score between 0 and 58. Scores equal to or less than 40 points would indicate a low parenting score
Family Quality of Life
时间窗: Pre-intervention, after six months of intervention, and follow-up six months later
The Families in Early Intervention Quality of Life (FEIQoL) in its Spanish version will be used. The FEIQoL asks families to rate 39 FQoL features (i.e., items) on a 5-point rating scale from 1 = poor to 5 = excellent. The FEIQoL is comprised of four factors: family relationships, access to information and services, overall life situation, and child functioning. The minimum score on the scale is 39 points and the maximum score that can be obtained is 195 points. The higher the score obtained, the higher the level of Family Quality of Life. The scale shows a high internal consistency for the total score (α = .94) and its factors ranged from α = .74 to α = .89.
Parental self-efficacy
时间窗: Pre-intervention, after six months of intervention, and follow-up six months later
The Spanish version of the Parental Sense of Competence Scale (PSOC) will be administered to assess parental self-efficacy. The PSOC is a 17-item self-report scale that measures perceived parental self-efficacy. Responses are scored on a 6 point likert scale (from strongly disagree (1) to strongly agree (6)). The minimum score on the scale is 17 points and the maximum score that can be obtained is 102 points. Scores on the PSOC are transformed into three scores, a total score and a score for value/conforting dimension and the dimension of skills/conforting. The higher the score obtained, the higher the level of parental self-efficacy. The internal consistency coefficient was 0.85 for the total scale, and 0.78 and 0.85 for the two dimensions respectively.
Quality of intervention with caregivers
时间窗: Intervention period
To examine the quality of this highly individualized VFI process carried out with caregivers, four scales domains (relationship building with families, responsiveness to family strengths, facilitation of caregiver-child interaction, and collaboration with caregivers) of the Home Visit Rating Scale, version 3 (HOVRS-3) will be used. HOVRS-3 is structured in a list format, with each scale listing four to seven descriptive items, and each item followed by four quality indicators-1 (needs support), 3 (adequate), 5 (good), and 7 (excellent)-formatted similarly to multiple-choice test items. When the HOVRS-3 home-visit quality scores were higher, means a better quality of home visiting and it is related to parenting scores and children development. The scale demonstrated high values of validity and reliability (alphas between 0.69 to 0.91 depending on subscales) and adequate predictive validity.
Family satisfaction with the intervention
时间窗: After six months of intervention
To evaluate family satisfaction with the intervention, we will use the Spanish version of the Client Satisfaction Questionnaire (CSQ-8). It is a short questionnaire of 8 items with a likert-type response range from 1 to 4. It includes two open questions regarding the most valued aspects of the intervention and those that should be improved. The minimum score on the questionnaire is 8 points and the maximum score that can be obtained is 32 points. The higher the score obtained, the higher the level of satisfaction with the intervention. The original tool presented an adequate internal consistency, obtaining an alpha of 0.93. To add greater validity and to be able to obtain data on caregivers' perceptions of the quality of their working relationship with the VFI intervenor, we will use the Spanish version of the Working Alliance Inventory Adapted to Home Visiting - Short Revised (WAI -SR-HV).
次要结局
- Children's development(Pre-intervention, after six months of intervention, and follow-up six months later)
研究者
Rosa Vilaseca
Associate professor
University of Barcelona