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Clinical Trials in Spain / NCT06604988
Unknown Not applicable

Effectiveness of Video-feedback for Positive Parenting with Children At Risk of ASD

NCT06604988 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-12-20
Last updated
2024-09-20

Condition(s) studied

Autism Spectrum Disorder (ASDParental Behaviors

Investigational drug(s) / intervention(s)

Video-feedback intervention to promote positive parenting

Video-feedback intervention to promote positive parenting: Each session will focus on three parental behaviours (that support child development) that have appeared clearly, frequently and consistently in the video (PICCOLO score of 2) in any of the 4 dimensions (affection, responsiveness, encouragement, teaching). Other aspects of parental behaviours that have scored 1 or 0 on the PICCOLO will also be considered, to increase their frequency or encourage their appearance. It is to be expected that all the behaviours collected in PICCOLO appear in one or more of the recordings, even if only occasionally. Behaviours that do not appear can be introduced through linking strategies with other behaviours in which parents show strength (for example, if a caregiver tends to name objects a lot, a link can be established between naming and asking the child the name of objects, if questions are behaviour that does not appear in the logs). In each session, the caregiver is shown video clips that clearly show the positive parenting behaviours.

Study summary

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.

Eligibility

Sex
ALL
Min age
24 Months
Max age
36 Months
Healthy volunteers
No
Inclusion Criteria: 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. Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Barcelona Barcelona Catalonia

More University of Barcelona trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06604988 on ClinicalTrials.gov ↗ ← All trials in Spain